Is Long-term Use of Amantadine Effective in PD?

Study Overview
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Brief Summary
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The investigator aims to assess whether long-term use of amantadine is effective in patients with Parkinson's disease.

Detailed Description
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Amantadine is used in the early stages of Parkinson's disease (PD). However, amantadine is known to be relatively weak compared to other antiparkinsonian drugs such as levodopa, dopamine agonist or Mao-B inhibitor and its effects are limited in early months, so it is rarely used than other drugs. Recently, several studies have identified the long-term effects of amantadine on dyskinesia, but the basis is still insufficient. Therefore, this study aims to investigate the long-term effectiveness of amantadine in patients with PD. Participants who have used amantadine since the early stages of diagnosis undergo clinical evaluations including the Montreal Cognitive Assessment (MoCA), Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Freezing of Gait-Questionnaire (FOG-Q), Non-motor Symptom Scale (NMSS) and Parkinson's Disease Questionnaire-39 (PDQ-39). Then, participants stop taking amantadine. To investigate the long-term effect, clinical evaluations except MoCA are repetitively assessed at 4- and 8-week follow-ups.

Official Title
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Is Long-term Use of Amantadine Effective in Parkinson Disease?

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Determination of drug effects through amantadine cessation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have been taking amantadine since the beginning of diagnosis Patients who have taken amantadine for more than five years Patients with Parkinson's disease who are aged 40 years or older Exclusion Criteria: Patient who stops amantadine or is hypersensitive to amantadine Patients who have undergone brain surgery, including deep brain stimulation Patient identified as atypical parkinsonism Patients with psychiatric conditions such as dementia, major depression or bipolar disorder who are difficult to assess Patients who are currently unable to follow up at our hospital

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD patients who have taken amantadine<br> | Drug: Determination of drug effects through amantadine cessation<br>* Patients will discontinue amantadine, which has been taken since beginning of diagnosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 132] | Baseline, 4 weeks | 
| Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 132] | Baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 52] | Baseline, 4 weeks | 
| Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 52] | Baseline, 8 weeks | 
| Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 52] | Baseline, 4 weeks | 
| Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 52] | Baseline, 8 weeks | 
| Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 24] | Baseline, 4 weeks | 
| Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 24] | Baseline, 8 weeks | 
| Change from baseline to 4-week f/u in Hohr and Yahr stage score | Hohr and Yahr stage score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 5] | Baseline, 4 weeks | 
| Change from baseline to 8-week f/u in Hohr and Yahr stage score | Hohr and Yahr stage score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 5] | Baseline, 8 weeks | 
| Change from baseline to 4-week f/u in Freezing of Gait Questionnaire score | Freezing of Gait Questionnaire score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 24] | Baseline, 4 weeks | 
| Change from baseline to 8-week f/u in Freezing of Gait Questionnaire score | Freezing of Gait Questionnaire score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 24] | Baseline, 8 weeks | 
| Change from baseline to 4-week f/u in Non-motor Symptom Scale score | Non-motor Symptom Scale score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 360] | Baseline, 4 weeks | 
| Change from baseline to 8-week f/u in Non-motor Symptom Scale score | Non-motor Symptom Scale score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 360] | Baseline, 8 weeks | 
| Change from baseline to 4-week f/u in Parkinson's Disease Questionnaire-39 score | Parkinson's Disease Questionnaire-39 score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 156] | Baseline, 4 weeks | 
| Change from baseline to 8-week f/u in Parkinson's Disease Questionnaire-39 score | Parkinson's Disease Questionnaire-39 score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 156] | Baseline, 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Amantadine, Long-term effect