Close
Interventional clinical trials ("drug trials") test the safety and efficacy of new drugs and treatments that could potentially help manage symptoms better or even slow or halt disease progression.
If you are interested in taking part in research, please contact us at movementdisorders@ucl.ac.uk
Research during COVID-19
Following the COVID-19 pandemic, researchers have been working to change the way we do clinical studies and trials to adapt to the new situation. Our top priority is to ensure the safety and wellbeing of research participants. In many cases this includes efforts to reduce the number and duration of visits to the hospital for research purposes. Many studies are now offering participants the option to complete some (or all) of the research-related activities from home, via telephone, video or on-line platforms. If you are taking part in ongoing research, or wish to take part in open or future research studies, please discuss this with the respective research team.
MDC researchers lead a wide range of clinical trials carried out across UCL-affiliated hospitals, including University College London Hospital (UCLH), National Hospital for Neurology and Neurosurgery at Queen Square and The Royal Free Hospital.
If you are unsure whether or not research participation is for you, you can find more information about how clinical trial are conducted and what can you expect if you choose to participate at our What research participation involves webpage. You can find more information on specific types of trials, tests and procedures used for clinical research on our Methods dictionary webpage.
Please note that the list of ongoing clinical trials is updated regularly, as some trials reach their recruitment capacity and stop enrolling new participants, and new trials open. If you would like to be notified whenever new trials which might be potentially suitable for you open for recruitment you are invited to sign up for our Research Registry.
For any general questions about participation in our clinical trials please contact our clinical research administration team at: movementdisorders@ucl.ac.uk.
Please click on the title of each trial in the list below for more information and see whether it might be suitable for you.
Open Trials - Recruiting Participants
TOP-HaT: Trial of Ondansetron to treat hallucinations in Parkinson's
COBALT: Combining memantine and cholinesterase inhibitors in Lewy Body dementia treatment
Op-TICS: Double blind comparison of optimised deep brain stimulation in severe Tourette's Syndrome
Upcoming Trials - Will Start Recruiting Participants Soon
ASPro-PD: Ambroxol to slow progression in Parkinson's disease
EJS ACT-PD: The Edmond J. Safra accelerating clinical trials in Parkinson's disease initiative
Open Trials - No Longer Recruiting Participants
CHIEF-PD: Cholinesterase inhibitors to prevent falls in Parkinson’s Disease
Exenatide-PD3: Exenatide as potential disease modifying treatment for Parkinson's
Completed Trials
SUNRISE-PD: Gene therapy for advanced stage Parkinson's Disease
M-STAR: Study of a potential treatment for Multiple System Atrophy
The UP Study: Trial of Ursodeoxycholic Acid (UDCA) for Parkinson’s Disease
MOVES-PD: For early-stage Parkinson’s patients with GBA gene mutation
STARTUP: Trial for urinary problems associated with Parkinson’s Disease
PD-STAT: Simvastatin as a neuroprotective treatment for moderate Parkinson's Disease
AiM-PD: Ambroxol in disease modification in Parkinson Disease
Open Trials - Recruiting Participants
ATH434-201: A Randomized, Double-Blind, Placebo-Controlled Study of ATH434 in Early Multiple System Atrophy
Why: Multiple system atrophy (MSA) is a rare neurodegenerative disorder that progresses quickly. MSA can cause many problems including poor balance and coordination, difficulty with movement, abnormal bladder control, sleep disturbances and poor blood pressure control. MSA is associated with the presence of harmful clusters of proteins in different regions of the brain. Increased levels of iron have also been observed in a structure of the brain called the substantia nigra of patients with MSA, and this contributes to formation of the harmful protein clusters. ATH434 is an experimental drug that may reduce this effect by binding to and redistributing excess iron, thereby preserving nerve cells, and improving motor function. This trial will help determine if ATH434 is safe and effective for treating MSA.
What: This trial aims to find out if ATH434 is safe and effective for treating MSA. The trial will last approximately 60 weeks and will compare the efficacy of the study drug (ATH434) against a placebo (dummy drug). Eligible participants will be randomly assigned to take the study drug or placebo twice daily for 52 weeks. Over the course of the study, participants will have 9 in-person clinic visits and 8 remote (telephone or video) visits. During clinic visits, participants may undergo some of the following tests: blood and urine sampling, magnetic resonance imaging (MRI), electroencephalogram (EEG), lumbar puncture, questionnaires about MSA symptoms, and more.
Who: People aged 30-78 years old diagnosed with MSA with motor symptoms for less than 4 years.
More information: ATH434 clinical trial page on clinicaltrials.gov
Contact: Viorica Chelban – Principal Investigator (v.chelban@ucl.ac.uk)
TOP-HaT: Trial of Ondansetron to Treat Hallucinations in Parkinson’s
Why: Visual hallucinations (seeing things that do not exist in reality) occur in as many as 60% of people with Parkinson’s. Visual hallucinations are often highly distressing and are associated with dementia and earlier care home placement. NHS treatment options are limited, and currently available medications are associated with significant harmful side effects. Ondansetron, a drug used to treat post-operative vomiting, was previously identified as a highly promising potential treatment for Parkinson’s hallucinations, based on reported past cases of people with Parkinson’s whose visual hallucinations were resolved following Ondansetron treatment. This clinical trial aims to establish whether Ondansetron has a clinically important effect on visual hallucinations in Parkinson’s and assess if it can become a cost effective treatment for the NHS.
What: The trial will compare treatment with Ondansetron to treatment with a placebo (a pill that looks identical to ondansetron but contains no drug), taken orally over 12 weeks, with follow up for a further 12 weeks. Participants will be randomly assigned to either a treatment group or placebo group. The trial will assess and measure hallucinations, delusions (false beliefs), Parkinson's symptoms (tremor, anxiety, sleep disturbance), memory, quality of life, possible side-effects (such as constipation and headache), and the proportion of people who drop out due to side effects or require additional treatment for their hallucinations.
Who: People with Parkinson’s who experience visual hallucinations at least weekly.
More information: TOP-HaT clinical trial page on ClinicalTrials.gov
Contact: Angelina Manoharan – Clinical Research Nurse (movementdisorders@ucl.ac.uk)
COBALT: Combining Memantine and Cholinesterase Inhibitors in Lewy Body Dementia Treatment
Why: Dementia with Lewy bodies (DLB) and Parkinson’s disease dementia (PDD) are related complex illnesses with a wide range of distressing symptoms. People with DLB/PDD have worse quality of life, more complex symptoms, higher care costs, and are more sensitive to medications than people with Alzheimer’s disease (AD). Acetylcholinesterase inhibitors (AChEI) are commonly used medicines that can help people with DLB/PDD by improving day to day functioning and thinking abilities. Another drug which might help is Memantine, used to treat moderate to severe confusion in AD. It may help to improve memory, awareness, and the ability to perform daily functions; however, it is not clear if taking Memantine with AChEI is beneficial for people with DLB/PDD. The aim of this trial is to find out if taking Memantine with AChEI improves overall health and functioning for people with DLB or PDD.
What: The COBALT trial will compare treatment with Memantine to treatment with a placebo (a pill that looks identical to Memantine but contains no drug). Participants will be randomly assigned to receive either Memantine or a placebo. Participants and their caregiver/informant will complete assessments at baseline, 6 months, and 12 months. During these appointments, participants and their caregiver/informant will also be asked to complete questionnaires about symptoms, quality of life, and financial impact. There will be four additional telephone appointments and an optional follow up call.
Who: People with diagnosed PDD or DLB taking an acetylcholinesterase inhibitor.
More information: COBALT trial website
Contact: Angelina Manoharan – Clinical Research Nurse (movementdisorders@ucl.ac.uk)
Op-TICS: Double Blind Comparison of Optimized Deep Brain Stimulation in Severe Tourette Syndrome
Why: Tourette syndrome (TS) is a neuropsychiatric disorder where patients exhibit multiple motor tics and at least one vocal tic. Medications or behavioural therapy can be used to control symptoms, however, there are a small number of patients with very severe tics who are unresponsive to conventional treatments, negatively impacting their quality of life. Deep brain stimulation (DBS) is a technique that involves the surgical implantation of two thin wires (electrodes) in the right and left globus pallidus – areas of the brain responsible for the control of body movement. The electrodes are connected to a stimulator placed on the chest under the skin that sends electrical signals to the brain. This type of surgery is routinely used for disorders such as Parkinson’s disease and has also been used in a smaller number of TS patients. The Op-TICS trial is a clinical investigation of the use of DBS, with a CE marked implantable device, to reduce severe motor and vocal tics in patients who suffer from TS.
What: Participants deemed eligible for surgery will undergo DBS. The first 6 months after surgery will be spent adjusting the amplitude and other parameters of stimulation with the aim of optimising the stimulation to make the treatment as beneficial as possible. After 6 months, participants will be randomly placed into two groups: one group will keep DBS switched on and the other will have DBS switched off for up to 2 weeks. Participants will then be reassessed and swapped to the other condition. The participants and doctors doing the assessments will not know if the DBS is switched on or off. This will test, in an unbiased way, whether any tic reduction is specifically due to DBS.
Who: People diagnosed with Tourette Syndrome who have not responded to conventional treatment.
More information: ISRCTN Registry trial page
Contact: Atiyyah Moosa – Op-TICS Trial Manager (CCTU.OPTICS@ucl.ac.uk)
ADEPT-DBS: A multi-centre, prospective study exploring the use of neuronal signals to identify the ideal location to implant and apply Deep Brain Stimulation (DBS) in the Treatment of Parkinson’s Disease
Why: Deep brain stimulation (DBS) is an established treatment for Parkinson’s disease (PD) and has been shown to improve the symptoms and quality of life of patients with PD. During DBS surgery, thin metal wires called leads are implanted into specific areas of the brain. To achieve maximal benefit from the treatment, DBS needs to be applied to the ideal location in the brain. This study investigates a new electrical signal called evoked resonant neural activity (ERNA), recorded from the DBS leads of patients with PD. The use of ERNA signals to identify the best location to implant DBS leads is experimental. The aim of ADEPT-PD is to evaluate whether ERNA can be safely and reliably recorded during DBS surgery and whether ERNA can identify the best location to implant DBS leads.
What: You will only be eligible to participate in ADEPT-DBS if you are planning to have DBS as part of your treatment for PD. Your DBS surgery will go ahead per routine treatment, and during the surgery ERNA signals will be recorded to try and identify the best location to implant DBS leads. The study will last approximately 16 months and require participants to attend 4-5 study visits, during which you may be asked to have X-rays of your brain and answer questionnaires about your health. You may also be eligible to participate in a sub-study occurring 3-6 months after your DBS surgery.
Who: People diagnosed with Parkinson’s disease planning to have DBS.
Contact: San San Xu – Neurology Fellow (sansan.xu@nhs.net)
BP43176 in People with Parkinson’s Disease
Why: Some evidence suggests that people with Parkinson’s disease have more inflammation in the brain. A key part of the inflammation in the brain is a protein called NLRP3. This study will test the safety of a drug called Selnoflast, which blocks NLRP3 and may reduce brain inflammation. Selnoflast is an experimental drug and has not yet been tested as a treatment for Parkinson’s disease.
What: The study will last about 3 months and include approximately 10 clinic visits. The first visit is a screening visit and will determine if you are eligible for the study. The screening visit will include a health questionnaire, blood samples, and taking an image of your brain (also known as a dopaminergic scan). If you are deemed eligible to participate, you will be randomly assigned to either receive the study drug (Selnoflast) or a placebo (dummy drug). You will be invited to attend clinic visits over the course of the study to undergo tests such as magnetic resonance imaging (MRI), lumbar puncture, blood samples, electrocardiograms, and more. Some clinic visits will be longer than others, and for longer visits, overnight accommodation can be provided, and you will be compensated for your time, up to £4,000.
Who: People aged 40-85 years diagnosed with Parkinson’s disease within the last 5 years.
More information: BP43176 trial page on ClinicalTrials.gov.
Contact: Angelina Manoharan – Clinical Research Nurse (movementdisorders@ucl.ac.uk)
LUMA: A Study to Assess the Safety of BIIB122 Tablets and if it Can Slow the Worsening of Early-Stage Parkinson's Disease in Participants Between the Ages of 30 and 80
Why: Parkinson’s disease is a progressive disease, which means symptoms worsen over time. LUMA aims to find out if taking BIIB122 delays the progression of Parkinson’s symptoms in people who are in the early stages of Parkinson’s.
What: Participants will undergo screening to confirm they are eligible for the study, which may include questionnaires, genetic testing, and imaging (DaT scan). Participants will be randomly assigned to receive either the study drug (BIIB122) or a placebo (a pill that looks like BIIB122 but contains no drug) taken once daily for a minimum of 48 weeks and maximum of 144 weeks. Participants will visit the research office 17 times over the course of the trial and some participants will have an additional 3 remote visits.
Who: People aged 30-80 years old diagnosed with Parkinson’s within the last 2 years and not taking medication for their Parkinson's.
More information: LUMA trial page on ClinicalTrials.gov
Contact: Marte Jensen – Research Assistant (marte.theilmannjensen@nhs.net)
Upcoming Trials - Will Start Recruiting Participants Soon
ASPro-PD: Ambroxol to Slow Progression in Parkinson Disease
Why: There are currently no treatments to slow or stop the progression of Parkinson’s disease (PD). ASPro-PD will compare treatment with Ambroxol, a drug currently licenced to treat respiratory conditions, to treatment with a placebo (dummy pill). The aim of the trial is to assess whether taking Ambroxol daily can slow down the progression of PD and to establish the safety of long-term use of Ambroxol.
What: Participants will be randomly assigned to receive either Ambroxol or a placebo three times daily for 104 weeks, including a two week dose escalation period. After this, all participants will receive Ambroxol three times a day for 26 weeks, including a 2-week dose escalation period. There will be an optional sub-study in which a cerebrospinal fluid sample will be taken on two occasions via a lumbar puncture procedure to measure Ambroxol drug levels and confirm whether Ambroxol has penetrated the cerebrospinal fluid and central nervous system.
Who: People who have been diagnosed with Parkinson’s within the last 6 years and on stable dopaminergic treatment for at least 3 months. Please visit the ASPro-PD website below to register your interest and find out if you are eligible for our other studies, PD-Frontline and RAPSODI.
More information: ASPro-PD website
Contact: Felicia Ikeji – Clinical Project Manager (cctu.aspro-pd@ucl.ac.uk)
EJS ACT-PD: The Edmond J Safra Accelerating Clinical Trials in Parkinson’s Disease Initiative
Why: Over 12 million people are predicted to have Parkinson’s by 2040 and there is a great need to find treatments to slow or stop disease progression. EJS ACT-PD is fast-tracking this process by using a multi-arm multi-stage (MAMS) approach where multiple drugs are tested at the same time against one placebo (dummy drug). In current clinical trials, potential treatments need to pass three phases of clinical testing to determine their safety and efficacy. Each time a phase ends, the trial infrastructure is dismantled and has to be rebuilt for the next phase. Currently, it can take more than 10 years for one treatment to go through this process, slowing down the evaluation of potential new treatments. EJS ACT-PD aims to test up to 9 potential treatments for Parkinson’s over three years.
What: Participants will be randomly assigned to receive one of multiple active treatments or a placebo. Throughout the trial, interim analyses will be conducted to determine if each treatment appears to be working. If a treatment appears to be working, it will continue being tested. If a treatment appears not to be working, it will be replaced with another treatment without stopping the trial. Recruitment will begin late 2024.
Who: People with diagnosed with Parkinson’s who have responded to dopaminergic treatment.
More information: EJS ACT-PD website
Contact: Georgia Mills – Research Project Manager (georgia.mills@ucl.ac.uk)
Open Trials - No Longer Recruiting Participants
CHIEF-PD: Cholinesterase inhibitors to prevent falls in Parkinson’s Disease
Why: Falls are a very frequent complication of Parkinson's disease affecting 60% of people with Parkinson's. Falls can result in broken bones, injuries, and hospital admissions. This clinical trial aims to determine whether a drug called Rivastigmine (a cholinesterase inhibitor), can prevent falls in people with Parkinson's. Cholinesterase inhibitors, including Rivastigmine, are currently used to treat people with memory problems in Parkinson's and other conditions. The effect of these drugs on falls in Parkinson's has been tested in 3 small trials showing that treatment has the potential to almost halve the number of falls. The current trial is a larger, phase 3 trial required to provide a more certain answer as to whether people with Parkinson's who fall should be treated with cholinesterase inhibitors.
What: Participants will be randomly assigned to either receive the study drug (ChEi) or a placebo (dummy) treatment via a patch. Participants will take the medication for 12 months and record any falls that they experience in home-diaries.
Who: People diagnosed with idiopathic (non-genetic) Parkinson's disease who have fallen in the previous year and are able to walk >10m without aids or assistance. People who are currently or have been previously treated with a cholinesterase inhibitor cannot take part in the trial.
More information: The CHIEF-PD Trial website, or visit the CHIEF-PD trial webpage on ISRCTN registry
Exenatide-PD3: Exenatide as potential disease modifying treatment for Parkinson's
Why: Dopamine replacement therapies can markedly improve the initial motor symptoms of Parkinson's disease (PD), but these have no effects on the subsequent progression of the disease, which leads to disabling, treatment refractory symptoms and signs. Therefore, there is a need to identify a drug that can slow down or stop the progression of the disease. Exenatide is a licensed drug for the treatment of diabetes. It has been shown to protect nerve cells in the laboratory, and earlier small clinical trials have indicated it could slow disease progression in people with PD. This trial aims to see if the results of beneficial effects of Exenatide in PD can be replicated in a large group of people.
What: Trial participants will be randomly allocated to receive Exenatide or placebo, which they will be taught to inject themselves under the skin once a week for two years. Participants will undergo an assessment at the beginning of the study and then again every 6 months during which the severity of their Parkinson's will be measured. Participants will also have blood tests to check the safety of Exenatide over the course of the trial.
Who: People with Parkinson’s taking some form of dopaminergic medication (such as L-Dopa or a dopamine agonist), able to be mobile without assistance during their best “ON” medication periods.
More information: Exenatide trial webpage
Completed Trials
SUNRISE-PD: Gene therapy for advanced stage Parkinson's Disease
What: OXB-102 is a gene therapy product designed to “reprogram” cells in a particular part of the brain (called the striatum) to start producing dopamine – the brain chemical missing in Parkinson’s. The gene therapy product will be administered during a surgical procedure by infusion directly into the relevant part of the brain. Participants will need to have at least four days of over-night stay in hospital to be monitored before and after surgery. Following surgery participants will be monitored regularly every three months over the first year and then annually for up to ten years. Some follow-up study visits will require an overnight stay at the hospital so that participants can be assessed with and without the effects of Parkinson’s medication. Assessments for this study will include MRI, CT and PET brain scans, blood and urine sample collections, physical, movement and neurological examinations and clinical tests and questionnaires evaluating Parkinson’s symptoms, cognitive function, activities of daily living, quality of life and more.
Who: People aged 48 to 70 years, with advanced stage Parkinson’s, with motor symptoms affecting both sides of the body
More information: OXB-102 trial page at clinicalTrial.gov
M-STAR: Study of a potential treatment for Multiple System Atrophy
Why: Myeloperoxidase (MPO) is an enzyme that is believed to contribute to neurodegeneration, and levels of MPO are increased in the brains of people with MSA. The experimental drug in this trial, called BHV-3241, is an MPO inhibitor, which means that it reduces the activity of MPO. By reducing MPO activity, BHV-3241 may possibly slow down the progression of MSA. The purpose of this trial is to evaluate the effectiveness and safety of BHV-3241 in the treatment of MSA.
What: Participants in the trial will be assigned to take either the study drug or placebo (orally) twice daily for about one year. During this time, participants will come to the clinical research site for 8 study visits. During study visits, participants will complete standard physical, neurological, blood and urine tests, as well as detailed assessments of their MSA symptoms, cognitive function (thinking and memory), mood and wellbeing. At the beginning and end of the trial, participants will also undergo MRI and lumbar punctures to collect cerebrospinal fluid (CSF) samples.
Who: People diagnosed with MSA, who are able to walk at least 10 steps without assistance of another person (use of assistive devices, such as walker or cane, is allowed).
More Information: Visit the M-STAR clinical trial webpage on clinicalTrials.gov.
The UP Study: Trial of Ursodeoxycholic Acid (UDCA) for Parkinson’s Disease
Why: This is a placebo-controlled drug trial that aims to assess the safety and tolerability of a drug called ursodeoxycholic acid (UDCA) in Parkinson's disease. UDCA has been in clinical use for the treatment of liver disease for over 30 years, and this trial will evaluate how it is tolerated when taken by patients with Parkinson's in higher doses than are currently used to treat liver disease. There is compelling evidence that UDCA rescues the function of the mitochondria (the “powerhouse” of the cell) and the overall aim of this work is to explore the potential of UDCA to slow down the progression of PD.
What: Participants will be assigned to receive either the study drug or placebo (dummy drug) (taken orally) for one year. Trial assessments will include MRI imaging scans, blood and urine sample collections and clinical tests and questionnaires. Participants will also be provided with a specialized sensor that will gather data on walking, posture, and movement in their home.
Who: People who were diagnosed with Parkinson’s within the past 3 years.
More information: Read the UP trial participant information leaflet or visit the UP trial webpage at ISRCTN registry.
MOVES-PD: For early-stage Parkinson’s patients with GBA gene mutation
What: MOVES-PD is a placebo-controlled phase 2 drug trial evaluating the safety and efficacy of a drug called GZ/SAR402671. The study drug will be taken orally for one year and participants will be followed-up for two more years post-treatment. Assessments will include blood & urine sample collections, lumbar puncture to collect cerebrospinal fluid (CSF) samples, movement disorders clinical scales and questionnaires and cognitive testing.
Who: Participants with early-stage Parkinson’s (symptoms started within last two years) who have a confirmed GBA gene mutation.
Publication: Peterschmitt, M. Judith et al. ‘Safety, Pharmacokinetics, and Pharmacodynamics of Oral Venglustat in Patients with Parkinson’s Disease and a GBA Mutation: Results from Part 1 of the Randomized, Double-Blinded, Placebo-Controlled MOVES-PD Trial’. 1 Jan. 2022 : 557 – 570.
More information: Visit the MOVES-PD ClinicalTrials.gov page
Glut1 DS: Trial of UX007 for the treatment of movement disorders associated with glucose transporter type 1 deficiency syndrome
What: A Multicentre placebo-controlled phase 3 drug trial evaluating the efficacy and safety of UX007 (the study drug) in the treatment of movement disorders associated with Glut1 DS. The study uses a cross-over design, meaning participants will receive 10 weeks of active treatment (the study drug) and 10 weeks of placebo treatment (dummy drug) in random order. Assessments will include clinical scales and questionnaires evaluating the frequency and duration of disabling paroxysmal movement disorder events, mobility and other physical functions and cognitive function.
Who: Children and adults (at least 6 years old) diagnosed with Glut1 DS confirmed by SLC2A1 mutation and experiencing multiple disabling paroxysmal movement disorder events.
More information: UX007 for Glut1DS trial page at clinicalTrial.gov
STARTUP: Trial for urinary problems associated with Parkinson’s Disease
Why: People with Parkinson’s often experience a combination of movement problems (such as slow walking or tremors) and other non-motor symptoms, including bladder issues like needing to use the toilet suddenly or using the toilet frequently during the night. Previous studies have shown that using a mild electrical stimulation (similar to a TENS machine) on a nerve in the lower ankle can improve bladder problems in some people. The STARTUP trial aims to find out if using the device will reduce bladder symptoms in people with Parkinson’s.
What: The therapeutic stimulation device works by placing electrodes (patches) near the ankle to stimulate a nerve that has connections to the bladder. Stimulation patches are placed on the skin above the nerve (this is painless, and no needles are involved). Trial participants will come for one visit at a local clinic where they will be shown how to use the device. Following the clinic visit, participants will be given the stimulation device and some questionnaires to take home. Participants will use the device in their home over a course of six weeks. The research team will telephone participants regularly throughout this time to offer support and reminders about treatment and questionnaires.
Who: Adults who have been diagnosed with Parkinson’s and have bladder problems (e.g., having to go to the toilet frequently and urgently).
More Information: Read the STARTUP trial participant information leaflet, or visit the STARTUP trial webpage on ISRCTN registry.
PD-STAT: Simvastatin as a neuroprotective treatment for moderate Parkinson's Disease
What: PD-STAT is a multicentre placebo-controlled drug trial evaluating the efficacy of simvastatin, a licensed cholesterol lowering medication, as a neuroprotective agent in Parkinson’s disease. The study drug will be administered orally for 2 years and participants will be followed-up for an additional two months post-treatment. Assessments will include blood & urine samples and clinical scales and questionnaires evaluating Parkinson’s symptoms, cognitive function, mood, and quality of life.
Who: Participants over 40 years of age diagnosed with Parkinson’s, taking dopaminergic treatment but experiencing wearing-off symptoms who have not taken any statin medications prior to the trial.
Publication: Stevens KN, Creanor S, Jeffery A, et al. Evaluation of Simvastatin as a Disease-Modifying Treatment for Patients With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2022;79(12):1232–1241. doi:10.1001/jamaneurol.2022.3718
More information: PD-STAT trial page at clinicalTrial.gov
IRL790 in Parkinson’s Dyskinesia
What: This study is a phase 2 placebo-controlled drug trial evaluating the efficacy of the study drug (IRL790) in reducing L-Dopa induced dyskinesias in people with Parkinson’s. Study drug will be taken orally for four weeks and assessments will include blood & urine sample collections and clinical tests and questionnaires evaluating Parkinson’s symptoms and frequency and severity of dyskinesias.
Who: People with Parkinson’s experiencing dyskinesias.
More information: IRL790 for Parkinson's dyskinesia trial page at clinicalTrial.gov
Publication: Initial IRL790 trial results summarized on the IRLAB Therapeutic website.
PASSPORT: Tau antibody in Progressive Supranuclear Palsy
What: PASSPORT is a placebo-controlled drug trial evaluating the efficacy and safety of an anti-tau antibody (BIIB092) for the treatment of Progressive Supranuclear Palsy (PSP). The study drug (BIIB092) will be administered by intravenous (IV) infusion once every 4 weeks for one year, with an extension of up to four years. Assessments will include MRI scans, blood & urine sample collections and clinical tests and questionnaires evaluating PSP symptoms, cognitive function, activities of daily living, quality of life and more.
Who: Participants over 41 years of age diagnosed with probable or possible PSP, able to walk independently or with assistant and able to complete pen-and-paper assignments.
More information: PASSPORT trial page at clinicalTrial.gov
Publication: Dam, T., Boxer, A.L., Golbe, L.I. et al. Safety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial. Nat Med 27, 1451–1457 (2021). https://doi.org/10.1038/s41591-021-01455-x
Short Pulse Width DBS
What: This study is a double-blind, cross-over pilot investigation exploring the effects of using a shorter than conventional pulse width stimulation on deep brain stimulation (DBS)-induced speech problems. Each participant will undergo one month of treatment with the normal pulse width and one of treatment with a short pulse width DBS. Clinical assessments will be repeated at the first research visit and again at the end of each treatment month. Assessments will include health-related questionnaires, recordings of speech and facial movements and assessment of movement. Participants will need to stay overnight at the hospital during the first research visit so they can be assessed with and without the effects of Parkinson’s medication.
Who: People with Parkinson’s who underwent bilateral subthalamic DBS treatment for at least 12 months, who are experiencing stimulation-induced slurring of speech.
More information: Trial page at clinicalTrial.gov
Publication: Viswas, D., Grover, T., Tripoliti, E., … , Foltynie, T. (2020). Short Versus Conventional Pulse-Width Deep Brain Stimulation in Parkinson's Disease: A Randomized Crossover Comparison. Movement Disorders, January 2020, DOI: 10.1002/mds.27863.
AiM-PD: Ambroxol in disease modification in Parkinson Disease
What: AiM-PD is an open label phase 2a drug trial evaluating the safety and markers indicating biological activity of Ambroxol, a licensed medication for respiratory conditions. The drug is administered orally in escalating doses over a period of 6 months. Assessments included blood, urine and cerebrospinal fluid (CSF) sample collections, clinical scales and questionnaires to evaluate Parkinson’s symptoms and cognitive testing.
Who: Participants over 40 years of age diagnosed with Parkinson’s disease.
More information: AiM-PD trial page at clinicalTrial.gov
Publication: Mullin, S., Smith, L., Lee, K., … , Schapira, A. V. H. (2020). Ambroxol for the Treatment of Patients with Parkinson Disease with and Without Glucocerebrosidase Gene Mutations: A Nonrandomized, Noncontrolled Trial. JAMA Neurology, DOI: 10.1001/jamaneurol.2019.4611.
Exenatide for disease modification in Parkinson’s Disease
What: This study is a phase 2a placebo-controlled drug trial of Exenatide, a licensed diabetes medication, in patients with moderate Parkinson’s disease. The study drug was administered by subcutaneous injections once weekly in addition to participants’ regular medication for one year and participants were followed-up for an additional 3 months post-treatment. Assessments included quantitative changes in dopamine transporter availability as measured by DaT-SCAN imaging, Exenatide levels measured in blood, urine and cerebrospinal fluid (CSF) and clinical tests and questionnaires evaluating PD symptoms, cognitive function, mood and quality of life.
Main findings: Exenatide improved Parkinson’s motor symptoms (evaluated while patients were off PD medication) and this effect was sustained after Exenatide treatment was completed.
More information: Exenatide trial page at clinicalTrial.gov
Publication: Athauda, D., Maclagan, K., Skene, S. S., … , Foltynie, T. (2017). Exenatide once weekly versus placebo in Parkinson’s disease: a randomised, double-blind, placebo-controlled trial. The Lancet, 390 (10103), pp:1664-1675. DOI: 10.1016/S0140-6736(17)31585-4