Testing amantadine add-on for motor fluctuations in advanced Parkinson's disease
Tests amantadine versus placebo for off-time in advanced Parkinson's disease patients.
Key facts
- Who runs it
- University Hospital, Toulouse
- Where
- Toulouse, FranceSee the site
- Trial code
- Registry title
- The Effect of Amantadine as add-on Therapy for Motor Fluctuations in Advanced Parkinson's Disease: a Randomized Double-blinded Placebo-controlled Trial
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 132 people, planned
- Started
- 1 May 2025
- Expected to end
- 31 Aug 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Amantadine (100mg) as add on therapy.
- Placebo
- Record updated
- 10 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 30 to 80 with advanced Parkinson's disease and motor fluctuations (OFF time) who have never taken amantadine.
- Age
- 30 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Parkinson's disease diagnosed at least 3 years ago, Hoehn and Yahr stage 2-3 when medication is working (Med ON). Signs of motor fluctuations for at least 4 weeks, with at least 2 hours a day in the OFF state, including morning akinesia, despite adjusted anti-parkinsonian treatment.
- Earlier treatment
- Must never have taken amantadine. Other oral add-on drugs for motor fluctuations are allowed. Anti-Parkinson drugs must be stable for at least 4 weeks before screening. Must not have had apomorphine infusion, deep brain stimulation or levodopa-carbidopa intestinal gel.
Main reasons for not taking part
- Atypical parkinsonism (PSP, MSA, Lewy body dementia, corticobasal degeneration)
- Cognitive impairment (Mini Mental Status Examination below 26) or dementia
- Unstable heart disease, psychiatric illness or behavioral disorder
- Any reason that makes amantadine unsafe, such as epilepsy, heart failure, kidney failure or allergy
- Pregnancy, or childbearing potential without highly effective contraception
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Parkinson's disease diagnosis in agreement with the MDS criteria (Postuma et al., 2015) for at least 3 years HY 2-3 in Med ON condition Age: 30-80 years Signs of motor fluctuations for at least 4 weeks before screening, with a mean total awake time in the off state of at least 2 h, including morning akinesia despite anti-parkinsonian drug adjustment (best medical treatment)" Amantadine naïve (all other oral add-on treatments for motor fluctuations are allowed) Concomitant anti-Parkinson drug use should be stable for at least 4 weeks prior to screening Patients affiliated or beneficiary of a social security scheme. Patients who signed the written informed consent form. Patients in capacity to complete Hauser diaries
Who cannot take part
- Severe or unpredictable periods in the Off-state, or both; Clinically significant and unstable cardiovascular disease, psychiatric illness (including major depression, dementia, impulse control, disorders, and suicide ideation), or any other medical disorder that might have placed the patient at increased risk; Patient with behavioral disorder, ECMP item ≥ 3 Patients previously submitted to advanced treatments: subcutaneous continuous apomorphine infusion, deep brain stimulation and levodopa-carbidopa intestinal gel; Patients with cognitive impairment (Mini Mental Status Examination < 26) Patients with a diagnosis of atypical parkinsonism (Progressive supranuclear Palsy, Multiple system atrophy, Lewy Body Dementia or Cortico-basal degeneration) Patients having any contraindication to amantadine treatment (see Summary of Product characteristic in the Appendix: known hypersensitivity to drugs of the amantadine class or any of the components, combination with anti-emetic neuroleptics, patient with a history of epilepsy, confusional state, hallucinations or severe psychoneurotic state not controlled by treatment, patient with a history of congestive heart failure or peripheral oedema, patient with a history of skin eczema) A history of neuroleptic malignant syndrome or nontraumatic Rhabdomyolysis; renal failure and renal insufficiency (creatinine > 150 µmol/L) states of agitation or confusion delirious syndromes or exogenous psychosis in the anamnesis Has received any other investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening or plans to use an investigational drug (other than the study intervention) during the study Pregnant female subjects or potential childbearing female participant without highly effective contraception
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 80 years old?
Where in France
- CHU ToulouseToulouse, FranceContact: Margherita FABBRI, MDNo longer taking part
About the trial
What the trial wants to find out
Motor fluctuations are identified as the most challenging symptoms by parkinson disease patients. A recent post-hoc analysis of ADS-5012 trials (new formulation of ER Amantadine), revealed a significant improvement in OFF-time. No randomized clinical trial has ever specifically investigated to date the effect of amantadine IR on motor fluctuations. The main objective of this study is to evaluate the effect of amantadine (300 mg/day) as add-on therapy for the treatment of motor fluctuations (Off-time) in advanced Parkinson's disease patients versus placebo after 3 months of treatment.
The 2 groups in the trial
- AmantadineTreatment being tested
Amantadine will be administered at the dose of 100 mg t.i.d or b.i.d. (if t.i.d. is not tolerated) over 12 weeks, after a period of 3 weeks of titration. The study treatment will be stopped after a dose decrease of 100 mg / day every 3 days.
Treatment: Amantadine (100mg) as add on therapy.
- PlaceboPlacebo, for comparison
Placebo tablets will be also administered b.i.d. or t.i.d over 12 weeks after a period of 3 weeks of titration. Placebo tablets will be indistinguishable from amantadine ones.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- The Effect of Amantadine as add-on Therapy for Motor Fluctuations in Advanced Parkinson's Disease: a Randomized Double-blinded Placebo-controlled Trial
- Plain-language title
- Testing amantadine add-on for motor fluctuations in advanced Parkinson's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06817200, who can take part
- Record updated
- 10 February 2025