Is Long-term Use of Amantadine Effective in PD?

Seoul National University Hospital32 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

Determination of drug effects through amantadine cessationDRUG

Patients will discontinue amantadine, which has been taken since beginning of diagnosis.

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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. \[minimum 0, maximum 132\]

Time frame: 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. \[minimum 0, maximum 132\]

Time frame: Baseline, 8 weeks

Secondary Outcomes

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. \[minimum 0, maximum 52\]

Time frame: 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. \[minimum 0, maximum 52\]

Time frame: 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. \[minimum 0, maximum 52\]

Time frame: Baseline, 4 weeks

Data from ClinicalTrials.gov

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