A randomized, double-blind, placebo-controlled, cross-over, multi-center study concerning the efficacy and safety of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease

UMIN ID: UMIN000000780

Registered date:01/08/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 2007/06/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 weeks) An administration of placebo (27 days) A wash out period (15 days) An administration of amantadine hydrochloride (27 days)

Outcome(s)

• Primary Outcome: 1) UPDRS (parts 3 and 4) and Goetz score (measurements after amantadine hydrochloride and after placebo administration) 2) Incidence of adverse events
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Comprehensive clinical study group concerning diagnosis, treatment, and prevention of the neurological disorders
• Secondary Sponsor: Musashi Hospital, National Center of Neurology and Psychiatry, Japan Ehime University Hospital
• Source(s) of Monetary Support: Ministry of Health, Labors and Welfare