Is Long-term Use of Amantadine Effective in PD?

NCT ID: NCT04260581

Last Updated: 2020-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-02-28

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD patients who have taken amantadine

Group Type: EXPERIMENTAL

Determination of drug effects through amantadine cessation

Intervention Type: DRUG

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

Interventions

Determination of drug effects through amantadine cessation

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

BS Jeon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

H-1909-072-1064

Identifier Type: -

Identifier Source: org_study_id