Is Long-term Use of Amantadine Effective in PD?

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04260581
• Other study ID #: H-1909-072-1064
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: February 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Determination of drug effects through amantadine cessation
Patients will discontinue amantadine, which has been taken since beginning of diagnosis.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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