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Ongoing Clinical Trials for Parkinson’s Disease

There are currently 38 clinical trials investigating new treatments and therapies for Parkinson’s disease across Europe. These studies are testing various approaches including gene therapies, new medications, infusion systems, and drug combinations to help manage symptoms and slow disease progression.

Clinical trial locations

Study of AAV2-GDNF for Adults with Moderate Parkinson’s Disease Using a Drug Combination

This trial is investigating AAV2-GDNF, a gene therapy approach for adults with moderate Parkinson’s disease. The treatment involves a single injection directly into a brain region called the putamen, which is involved in movement control.

Main focus: The study aims to determine if AAV2-GDNF can improve or stabilize motor symptoms in patients at Hoehn and Yahr stage 2-3 who have been diagnosed with Parkinson’s disease for 4-10 years. The therapy delivers a gene that produces GDNF (Glial cell line-Derived Neurotrophic Factor), a protein that may help protect and repair nerve cells affected by the disease.

Who can participate: Adults aged 45-75 years with idiopathic Parkinson’s disease diagnosed 4-10 years ago, who show improvement with levodopa medication and have bradykinesia (slowness of movement) plus at least one other key symptom such as rigidity, resting tremor, or postural instability.

Treatment approach: Participants receive either AAV2-GDNF or placebo through a single injection into the brain. Throughout the study, patients continue their regular Parkinson’s medications and undergo regular assessments including MRI scans and neurological examinations to monitor changes in symptoms and safety.

Study of apomorphine and rifaximin for Parkinson’s disease patients with reduced levodopa effectiveness

This study is testing different treatment approaches for patients whose bodies break down levodopa too quickly, reducing its effectiveness. The research compares apomorphine (a medication that directly stimulates dopamine receptors) and rifaximin (an antibiotic) to see which helps manage symptoms better.

Main focus: The trial aims to improve symptom management in patients who have developed resistance to standard levodopa treatment, as indicated by increased levels of certain enzymes (AADC or TDC) that break down the medication before it can work properly.

Who can participate: Dutch-speaking adults aged 25 and older with neurologist-confirmed Parkinson’s disease who have documented levodopa resistance and elevated enzyme levels in blood or stool samples. Participants must be able to temporarily stop taking Parkinson’s medication for up to 12 hours at multiple points during the study.

Treatment approach: Participants receive either rifaximin tablets (550 mg) or placebo by mouth, along with apomorphine injections under the skin. The study also uses domperidone to prevent potential side effects. Throughout the trial, patients continue their regular Madopar medication while researchers monitor their response to the different treatment combinations.

Study of CVN424 for Reducing Motor Complications in Parkinson’s Disease Patients

This trial is investigating CVN424, a once-daily tablet medication designed to reduce “OFF time” in patients with Parkinson’s disease. OFF time refers to periods when regular medications aren’t working well and symptoms return or worsen.

Main focus: The study evaluates whether CVN424 can reduce the amount of time patients experience motor complications, specifically measuring changes in daily OFF time over a 12-week treatment period. Researchers will also assess improvements in overall quality of life and symptom control.

Who can participate: Adults aged 30-80 years who have been diagnosed with Parkinson’s disease for at least 3 years, are in Hoehn & Yahr stage I-IV when on medication, and experience at least 3 hours of OFF time per day despite stable medication doses for the past 4 weeks. Participants must also be able to accurately track their ON/OFF periods in a diary.

Treatment approach: Participants are randomly assigned to receive either CVN424 (150 mg) or placebo once daily for 12 weeks. Throughout the study, patients keep a daily diary recording their motor symptoms and OFF periods. Regular assessments monitor safety, side effects, and changes in motor function using standard Parkinson’s disease rating scales.

Study of Radotinib safety and effectiveness compared to placebo in people with Parkinson’s disease

This French study is testing Radotinib HCl, an investigational medication, in patients with early Parkinson’s disease. The research focuses on people who were diagnosed within the past 3 years and have not yet started regular treatment for their condition.

Main focus: The primary goal is to determine if Radotinib is safe and well-tolerated in patients with early-stage Parkinson’s disease. The study will test different doses (50 mg, 100 mg, 150 mg, or 200 mg) over a 6-month period to find the most appropriate dosage.

Who can participate: Men and women aged 40-80 years with normal blood pressure and heart function, diagnosed with Parkinson’s disease within the last 3 years, who have a positive DAT-scan confirming decreased dopamine function. Participants must have mild to moderate disease (Hoehn & Yahr stage 2.5 or less) and not have received any previous Parkinson’s disease treatment.

Treatment approach: Participants receive either Radotinib capsules or placebo by mouth for 6 months. Throughout the study, researchers monitor symptoms using the MDS-UPDRS rating scale, conduct regular health checks including ECGs and blood tests, and assess quality of life using the PDQ-39 questionnaire. The study aims to understand how the medication affects both motor and non-motor symptoms.

Study on Donepezil for Mild Cognitive Impairment in Parkinson’s Disease Patients

This Spanish trial is investigating whether donepezil, a medication typically used for Alzheimer’s disease, can help improve cognitive function in Parkinson’s disease patients experiencing mild cognitive impairment. The study runs for 12 months.

Main focus: The research evaluates if donepezil can improve thinking skills, memory, and cognitive performance in people with Parkinson’s disease who have mild cognitive impairment. This condition affects memory and thinking but is not severe enough to be classified as dementia.

Who can participate: Adults aged 50-80 years with clinically confirmed Parkinson’s disease (stages I-III on the Hoehn and Yahr scale) who have experienced personal concerns about memory or thinking problems for at least 6 months. Participants must have a MoCA score between 20-24 and have been diagnosed with Parkinson’s-related mild cognitive impairment at least 3 months before the study. They must also be on stable dopaminergic treatment for at least 4 weeks.

Treatment approach: Participants are randomly assigned to receive either donepezil (ARICEPT 10mg) or placebo once daily for 12 months, while continuing their regular Parkinson’s medications. Throughout the study, researchers conduct regular cognitive assessments using scales like PD-CRS and PD-CFRS, along with tests measuring memory, fluency, mood, and daily functioning to track changes in cognitive abilities.

Study on How Exenatide Affects Early Parkinson’s Disease Progression in Patients

This Swedish study is investigating Exenatide (Bydureon), a medication given as a weekly injection under the skin, to see if it can slow down the progression of motor symptoms in people with early Parkinson’s disease.

Main focus: The trial aims to understand how Exenatide affects the brain and whether it can help slow the worsening of motor symptoms in early-stage disease. Researchers will use advanced imaging techniques and various assessments to measure changes over time.

Who can participate: Adults aged 25-80 years with a confirmed Parkinson’s disease diagnosis who successfully completed a previous Exenatide trial. Participants must be at Hoehn and Yahr stage 2 or less when on medication, currently taking levodopa, and have experienced no major changes in treatment or movement abilities over the past year. They must also be able to administer the injection themselves or have help from a study partner.

Treatment approach: Participants receive Bydureon (2 mg) as a weekly injection under the skin. The study includes an open-label extension phase, meaning all participants receive the active medication. Throughout the trial, researchers monitor participants through FDG-PET network analysis, MDS-UPDRS assessments, and various other scales measuring motor symptoms, cognitive function, and quality of life at baseline, 9 months, and 21 months.

Study on Montelukast for Slowing Parkinson’s Disease Progression in Patients with Mild to Moderate Symptoms

This Swedish trial is testing whether Montelukast, a medication typically used for asthma and allergies, can slow disease progression in people with early to moderate Parkinson’s disease. The treatment is delivered as a buccal film (placed inside the cheek to dissolve).

Main focus: The study aims to determine if Montelukast can slow the progression of motor symptoms in early to moderate-stage Parkinson’s disease over an 18-month period. Researchers will measure changes in movement abilities using the MDS-UPDRS Part 3 scale when participants are in an OFF-medication state.

Who can participate: Adults aged 35-80 years with a Parkinson’s disease diagnosis for less than 4 years, currently taking levodopa on stable doses for at least 4 weeks. Participants must be at H&Y stage 2 or below in the OFF state, able to take the trial medication independently, and show improvement with levodopa treatment. Women of childbearing potential must use effective birth control.

Treatment approach: Participants receive either Montelukast buccal film or placebo while continuing their regular levodopa treatment. The medication is placed inside the cheek to dissolve. Throughout the 21-month study, regular assessments monitor motor and non-motor symptoms, anxiety, depression, and any adverse events at 6, 12, 18, and 21 months.

Study on Pain in Parkinson’s Disease: Examining the Effects of 18F-MPPF in Patients with and without Pain

This French study uses specialized brain imaging with a substance called 18F-MPPF to understand how the brain processes pain in people with Parkinson’s disease. The research compares patients who experience pain with those who do not.

Main focus: The study investigates the role of the serotonin system in pain experienced by Parkinson’s disease patients. By using PET scans with 18F-MPPF, researchers can visualize serotonin receptor activity in the brain and see how it differs between people with pain and those without.

Who can participate: Men and women aged 40-80 years with Parkinson’s disease diagnosed according to specific criteria, who have been on stable treatment for at least 4 weeks. Participants must have a MoCA score greater than 25 (indicating preserved cognitive function) and a HADS-D score of 11 or less (no significant depression). They must be affiliated with a social security scheme and provide written informed consent.

Treatment approach: Participants receive an intravenous injection of 18F-MPPF followed by PET scanning to visualize brain serotonin receptors. The study also includes MRI scans to examine brain structure and function. Throughout the research, participants undergo assessments of motor and non-motor symptoms to understand the relationship between brain characteristics and pain experiences in Parkinson’s disease.

Study on Safinamide and Rasagiline for Treating Fatigue in Parkinson’s Disease Patients on Stable Dopaminergic Treatment

This Spanish trial compares two medications, Safinamide and Rasagiline, to see which better reduces persistent fatigue in people with Parkinson’s disease who are already on stable treatment.

Main focus: The study aims to evaluate the safety and effectiveness of these two medications in reducing fatigue, a common and debilitating symptom that significantly impacts daily life in Parkinson’s disease. The primary measure is change in the Fatigue Severity Scale (FSS) score over 24 weeks.

Who can participate: Men and women aged 50-80 years with a Parkinson’s disease diagnosis for at least 3 years, who are in stages I-IV on the Hoehn and Yahr scale when on medication. Participants must have experienced fatigue for at least one month with an FSS score of 8 or higher, have been on stable levodopa doses for at least 4 weeks, and have brain imaging consistent with Parkinson’s disease.

Treatment approach: Participants are randomly assigned to receive either Safinamide (100 mg per day) or Rasagiline (1 mg per day) orally for 24 weeks while continuing their regular Parkinson’s medications. Throughout the study, regular monitoring includes blood pressure, heart rate, ECGs, blood tests, and assessments using the MDS-UPDRS scale, PDQ-8, and NMSQuest to track motor symptoms, quality of life, and non-motor symptoms.

Study on the Safety and Effects of ACI-7104.056 in Patients with Early Parkinson’s Disease

This trial, conducted in Spain and Germany, is testing ACI-7104.056, a vaccine designed to help the body produce antibodies that may protect against Parkinson’s disease progression. The treatment involves an injection into the muscle.

Main focus: The study evaluates the safety and tolerability of the vaccine in patients with early Parkinson’s disease (diagnosed for less than 10 years). Researchers will monitor how the body responds to the vaccine and measure antibody production over several years.

Who can participate: Adults aged 40-75 years weighing 45-110 kg (99-242 lbs) with body mass index between 18-34 kg/m², who have early-stage idiopathic Parkinson’s disease (Modified Hoehn-Yahr Stage I-II). Participants must be taking L-Dopa at 300 mg per day with stable doses for at least 3 months, and have a brain DaT-SPECT scan consistent with Parkinson’s disease. Women must be postmenopausal or using effective birth control.

Treatment approach: Participants receive either ACI-7104.056 vaccine or placebo through intramuscular injection while continuing their regular L-Dopa treatment. The study includes regular follow-up visits for physical and neurological examinations, brain imaging (DaT-SPECT at 48 and 100 weeks), MRI scans, ECGs, blood and urine tests, and assessments using the MDS-UPDRS Part III score to monitor motor symptoms over 100 weeks.

Study on the Safety and Effects of BIIB122 for Patients with LRRK2-Associated Parkinson’s Disease

This study in Spain and Germany is testing BIIB122, an oral tablet medication, specifically for people with Parkinson’s disease who have a genetic mutation in the LRRK2 gene. This genetic form represents a specific subtype of the disease.

Main focus: The trial assesses the safety and tolerability of BIIB122 over a 12-week period, measuring changes in specific biological markers (biomarkers) in blood and urine that are related to Parkinson’s disease and the LRRK2 gene mutation.

Who can participate: Adults aged 30-80 years (or at least 30 if they have two copies of the LRRK2 mutation) with clinically diagnosed Parkinson’s disease who have confirmed pathogenic variants in the LRRK2 gene through genetic testing. Both men and women can participate.

Treatment approach: Participants are randomly assigned to receive either BIIB122 or placebo in tablet form taken by mouth. Throughout the 12-week study, researchers monitor safety through regular health assessments and track changes in biomarkers from baseline to the end of treatment. The study aims to understand how the medication affects the body and whether it can help manage symptoms of this specific genetic form of Parkinson’s disease.

Summary

The 38 ongoing clinical trials for Parkinson’s disease demonstrate diverse approaches to treatment, spanning multiple countries across Europe. A notable concentration of trials is taking place in Spain, Germany, France, Italy, and Poland, reflecting these countries’ strong research infrastructure in neurological disorders.

Several trials focus on novel drug delivery systems, particularly continuous infusion therapies like ND0612, which aim to provide more consistent symptom control compared to traditional oral medications. Gene therapy approaches, such as AAV2-GDNF, represent innovative strategies to potentially modify disease progression rather than just managing symptoms.

A significant number of studies target specific patient populations, including those with genetic mutations (LRRK2, GBA1), early-stage disease, or specific symptoms like tremor, pain, or cognitive impairment. This personalized approach reflects the growing understanding that Parkinson’s disease varies considerably between individuals.

The trials employ various outcome measures beyond motor symptoms, including quality of life assessments, cognitive function tests, and non-motor symptom evaluations, recognizing that Parkinson’s disease affects many aspects of daily living beyond movement difficulties.

Ongoing Clinical Trials on Parkinson’s disease

  • Study of Radotinib safety and effectiveness compared to placebo in people with Parkinson’s disease

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Safety and Tolerability of Exidavnemab in Patients with Mild to Moderate Parkinson’s Disease

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Poland Spain

  • Study on the Effectiveness and Safety of ND0612 Infusion vs. Oral Treatment for Parkinson’s Disease Patients with Motor Fluctuations

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Italy Poland +3

  • Study on the Effectiveness and Safety of BIIB122 for Patients with Parkinson’s Disease

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Austria France Germany Italy The Netherlands Poland +1

  • Study on the Safety and Effects of Afamelanotide for Patients with Early Parkinson’s Disease

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Long-Term Safety of Tavapadon for Patients with Parkinson’s Disease

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia France Germany Hungary Italy +2

  • Study on the Long-Term Safety of ND0612 (Carbidopa, Levodopa) Infusion for Patients with Advanced Parkinson’s Disease

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria France Italy Poland

  • Study on the Long-Term Safety and Effectiveness of Minzasolmin and Iodine Ioflupane (123I) in Patients with Parkinson’s Disease

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Poland Spain

  • Study on BIA 28-6156 for Parkinson’s Disease in Patients with GBA1 Gene Variant

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Poland Portugal +2

  • Study of Suvecaltamide for Treating Moderate to Severe Tremor in Parkinson’s Disease Patients

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Germany Poland Spain

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