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Is Long-term Use of Amantadine Effective in PD?

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Determination of drug effects through amantadine cessation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Amantadine, Long-term effect

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD patients who have taken amantadine

Arm Description

Outcomes

Primary Outcome Measures

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]
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]

Secondary Outcome Measures

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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]

Full Information

First Posted
February 5, 2020
Last Updated
February 6, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04260581
Brief Title
Is Long-term Use of Amantadine Effective in PD?
Official Title
Is Long-term Use of Amantadine Effective in Parkinson Disease?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
February 28, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, Amantadine, Long-term effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PD patients who have taken amantadine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Determination of drug effects through amantadine cessation
Intervention Description
Patients will discontinue amantadine, which has been taken since beginning of diagnosis.
Primary Outcome Measure Information:
Title
Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score
Description
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
Title
Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score
Description
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 Outcome Measure Information:
Title
Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score
Description
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
Title
Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score
Description
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
Title
Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score
Description
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
Title
Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score
Description
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, 8 weeks
Title
Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score
Description
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]
Time Frame
Baseline, 4 weeks
Title
Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score
Description
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]
Time Frame
Baseline, 8 weeks
Title
Change from baseline to 4-week f/u in Hohr and Yahr stage score
Description
Hohr and Yahr stage score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 5]
Time Frame
Baseline, 4 weeks
Title
Change from baseline to 8-week f/u in Hohr and Yahr stage score
Description
Hohr and Yahr stage score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 5]
Time Frame
Baseline, 8 weeks
Title
Change from baseline to 4-week f/u in Freezing of Gait Questionnaire score
Description
Freezing of Gait Questionnaire score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 24]
Time Frame
Baseline, 4 weeks
Title
Change from baseline to 8-week f/u in Freezing of Gait Questionnaire score
Description
Freezing of Gait Questionnaire score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 24]
Time Frame
Baseline, 8 weeks
Title
Change from baseline to 4-week f/u in Non-motor Symptom Scale score
Description
Non-motor Symptom Scale score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 360]
Time Frame
Baseline, 4 weeks
Title
Change from baseline to 8-week f/u in Non-motor Symptom Scale score
Description
Non-motor Symptom Scale score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 360]
Time Frame
Baseline, 8 weeks
Title
Change from baseline to 4-week f/u in Parkinson's Disease Questionnaire-39 score
Description
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]
Time Frame
Baseline, 4 weeks
Title
Change from baseline to 8-week f/u in Parkinson's Disease Questionnaire-39 score
Description
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]
Time Frame
Baseline, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Is Long-term Use of Amantadine Effective in PD?

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