Parkinson'
Conditions
Interventions
An observation period (2 to 3 weeks) An administration of amantadine hydrochloride (27 days) A wash out period (15 days) An administration of placebo (27 days)
An observation period (2 to 3 w
Sponsors
Comprehensive clinical study group concerning diagnosis, treatment, and prevention of the neurological disorders
Musashi Hospital, National Center of Neurology and Psychiatry, Japan Ehime University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients are 20 to 75 years-old, diagnosed as Parkinson disease (according to steps 1 and 2 of U.K. Parkinson's disease Society brain bank diagnostic criteria), and with dyskinesias of the limbs and the trunk
Exclusion criteria
Exclusion criteria: 1) Patients prescribed with amantadine hydrochloride during the previous 2 weeks 2) Patients with psychiatric symptoms such as auditory hallucination or delusions 3) According to the following formula, creatinine clearance is less than 75mL/min/1.73m2 Male : (140-age)X weight(kg)/(72 X serum creatinine)(mg/dL) Female : (140-age)X weight(kg)X 0.85/(72 X serum creatinine)(mg/dL) 4) Remarkable liver damage 5) Pregnant or possibly pregnant 6) History of epilepsy 7) Patients who are judged as inappropriate participants in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) UPDRS (parts 3 and 4) and Goetz score (measurements after amantadine hydrochloride and after placebo administration) 2) Incidence of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Correlation between blood concentrations of amantadine hydrochloride and the UPDRS (parts 3 and 4) and Goetz score changes 2) UPDRS (parts 3 and 4) and Goetz score changes stratified by the types of dyskinesias | — |
Countries
Japan
Contacts
Public ContactKyoko Tsunamoto / Kaho Ishibashi
Utano National Hospital, National Hospital Organization Clinical Research Institute
Outcome results
None listed