Is Long-term Use of Amantadine Effective in PD?

NCT04260581 | Unknown

• 1 other identifier: H-1909-072-1064
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Amantadine; Long-term effect

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (14)

• Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score

  Baseline, 4 weeks

• Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score

  Baseline, 8 weeks

• Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score

  Baseline, 4 weeks

• Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score

  Baseline, 8 weeks

• Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score

  Baseline, 4 weeks

Study Arms (1)

PD patients who have taken amantadine

EXPERIMENTAL

Drug: Determination of drug effects through amantadine cessation

Interventions

Determination of drug effects through amantadine cessation DRUG

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

PD patients who have taken amantadine

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: March 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)