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The effect of amantadine as add-on therapy for motor fluctuations in advanced Parkinson’s disease: a randomized double-blinded placebo-controlled trial
EU CTIS ID: 2023-509728-16-00
What this study is testing
The main objective of this study is to evaluate the effect of amantadine 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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)Patients who have taken Amantadine less than 7 days can be included if they did not stop Amantadine because of side effects or lack of efficacy.
- Patients affiliated or beneficiary of a social security scheme
You likely can't join if
- • Severe or unpredictable periods in the Off-state, or both
- • Patient with behavioral disorder, ECMP item ≥ 3
- • Patients with on-going advanced treatments: subcutaneous continuous apomorphine infusion, levodopa-carbidopa intestinal gel and foslevodopa/foscarbidopa subcutaneous pump;
- • 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 previously submitted to deep brain stimulation
See the full eligibility criteria
- 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)Patients who have taken Amantadine less than 7 days can be included if they did not stop Amantadine because of side effects or lack of efficacy.
- Patients affiliated or beneficiary of a social security scheme
- Patients who signed the written informed consent form.
- Patients in capacity to complete Hauser diaries
- Concomitant anti-Parkinson drug use should be stable for at least 4 weeks prior to screening
- • Severe or unpredictable periods in the Off-state, or both
- • Patient with behavioral disorder, ECMP item ≥ 3
- • Patients with on-going advanced treatments: subcutaneous continuous apomorphine infusion, levodopa-carbidopa intestinal gel and foslevodopa/foscarbidopa subcutaneous pump;
- • 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 previously submitted to deep brain stimulation
- • 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, patients with history of mild eczema will be allowed to participate and closely monitored)
- • A history of neuroleptic malignant syndrome or nontraumatic Rhabdomyolysis;
- • renal failure and renal insufficiency (creatinine > 150 µmol/L)
- • 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
- • states of agitation or confusion
- • delirious syndromes or exogenous psychosis in the anamnesis
- • Pregnant female subjects or potential childbearing female participant without highly effective contraception
- • 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;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.