Clinical trial NCT04260581: Is Long-term Use of Amantadine Effective in PD?
Official title: Is Long-term Use of Amantadine Effective in Parkinson Disease?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Amantadine
Long-term effect
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score
timeFrame: Baseline, 4 weeks
measure: Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score
timeFrame: Baseline, 4 weeks
measure: Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score
timeFrame: Baseline, 8 weeks
measure: Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score
timeFrame: Baseline, 4 weeks
measure: Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score
timeFrame: Baseline, 8 weeks
measure: Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score
timeFrame: Baseline, 4 weeks
measure: Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score
timeFrame: Baseline, 8 weeks
measure: Change from baseline to 4-week f/u in Hohr and Yahr stage score
timeFrame: Baseline, 4 weeks
measure: Change from baseline to 8-week f/u in Hohr and Yahr stage score
timeFrame: Baseline, 8 weeks
measure: Change from baseline to 4-week f/u in Freezing of Gait Questionnaire score
timeFrame: Baseline, 4 weeks
measure: Change from baseline to 8-week f/u in Freezing of Gait Questionnaire score
timeFrame: Baseline, 8 weeks
measure: Change from baseline to 4-week f/u in Non-motor Symptom Scale score
timeFrame: Baseline, 4 weeks
measure: Change from baseline to 8-week f/u in Non-motor Symptom Scale score
timeFrame: Baseline, 8 weeks
measure: Change from baseline to 4-week f/u in Parkinson's Disease Questionnaire-39 score
timeFrame: Baseline, 4 weeks
measure: Change from baseline to 8-week f/u in Parkinson's Disease Questionnaire-39 score
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: