Is Long-term Use of Amantadine Effective in PD?

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

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

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Determination of drug effects through amantadine cessation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PD patients who have taken amantadine	Drug: Determination of drug effects through amantadine cessation; Patients will discontinue amantadine, which has been taken since beginning of diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2020
• Primary Completion (ANTICIPATED): February 28, 2021
• Study Completion (ANTICIPATED): February 28, 2021

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (ACTUAL): February 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Parkinson's disease; Amantadine; Long-term effect
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Amantadine
• Other Study ID Numbers: H-1909-072-1064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No