Parkinson Disease
Conditions
Keywords
Parkinson's disease, Amantadine, Long-term effect
Brief summary
The investigator aims to assess whether long-term use of amantadine is effective in patients with Parkinson's disease.
Detailed description
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.
Interventions
DRUGDetermination of drug effects through amantadine cessation
Patients will discontinue amantadine, which has been taken since beginning of diagnosis.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients who have been taking amantadine since the beginning of diagnosis 2. Patients who have taken amantadine for more than five years 3. Patients with Parkinson's disease who are aged 40 years or older
Exclusion criteria
1. Patient who stops amantadine or is hypersensitive to amantadine 2. Patients who have undergone brain surgery, including deep brain stimulation 3. Patient identified as atypical parkinsonism 4. Patients with psychiatric conditions such as dementia, major depression or bipolar disorder who are difficult to assess 5. Patients who are currently unable to follow up at our hospital
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score | Baseline, 4 weeks | 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. \[minimum 0, maximum 132\] |
| Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score | Baseline, 8 weeks | 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. \[minimum 0, maximum 132\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score | Baseline, 4 weeks | 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. \[minimum 0, maximum 52\] |
| Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score | Baseline, 8 weeks | 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. \[minimum 0, maximum 52\] |
| Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score | Baseline, 4 weeks | 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. \[minimum 0, maximum 24\] |
| Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score | Baseline, 8 weeks | 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. \[minimum 0, maximum 24\] |
| Change from baseline to 4-week f/u in Hohr and Yahr stage score | Baseline, 4 weeks | Hohr and Yahr stage score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. \[minimum 0, maximum 5\] |
| Change from baseline to 4-week f/u in Parkinson's Disease Questionnaire-39 score | Baseline, 4 weeks | Parkinson's Disease Questionnaire-39 score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. \[minimum 0, maximum 156\] |
| Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score | Baseline, 4 weeks | 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. \[minimum 0, maximum 52\] |
| Change from baseline to 4-week f/u in Freezing of Gait Questionnaire score | Baseline, 4 weeks | Freezing of Gait Questionnaire score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. \[minimum 0, maximum 24\] |
| Change from baseline to 8-week f/u in Freezing of Gait Questionnaire score | Baseline, 8 weeks | Freezing of Gait Questionnaire score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. \[minimum 0, maximum 24\] |
| Change from baseline to 4-week f/u in Non-motor Symptom Scale score | Baseline, 4 weeks | Non-motor Symptom Scale score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. \[minimum 0, maximum 360\] |
| Change from baseline to 8-week f/u in Non-motor Symptom Scale score | Baseline, 8 weeks | Non-motor Symptom Scale score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. \[minimum 0, maximum 360\] |
| Change from baseline to 8-week f/u in Parkinson's Disease Questionnaire-39 score | Baseline, 8 weeks | Parkinson's Disease Questionnaire-39 score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. \[minimum 0, maximum 156\] |
| Change from baseline to 8-week f/u in Hohr and Yahr stage score | Baseline, 8 weeks | Hohr and Yahr stage score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. \[minimum 0, maximum 5\] |
| Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score | Baseline, 8 weeks | 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. \[minimum 0, maximum 52\] |
Countries
South Korea
Outcome results
None listed