Is Long-term Use of Amantadine Effective in PD?
- Conditions
- Parkinson Disease
- Interventions
- Drug: Determination of drug effects through amantadine cessation
- Registration Number
- NCT04260581
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PD patients who have taken amantadine Determination of drug effects through amantadine cessation -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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. \[minimum 0, maximum 52\]
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 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 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 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 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 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 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 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. \[minimum 0, maximum 360\]
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of