Is Long-term Use of Amantadine Effective in PD?

Seoul National University

Status: Unknown

Conditions: Parkinson Disease

Treatments: Drug: Determination of drug effects through amantadine cessation

Study type: Interventional

Funder types: Other

Identifiers

NCT04260581

H-1909-072-1064

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

32 participants in 1 patient group

PD patients who have taken amantadine

Experimental group

Treatment:

Drug: Determination of drug effects through amantadine cessation