NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000780

Registered date:01/08/2007

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedParkinson's disease
Date of first enrollment2007/06/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
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 Outcome1) UPDRS (parts 3 and 4) and Goetz score (measurements after amantadine hydrochloride and after placebo administration) 2) Incidence of adverse events
Secondary Outcome1) 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 minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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

Contact

public contact
Name Kyoko Tsunamoto / Kaho Ishibashi
Address 8, Ondoyama, Narutaki, Ukyo-ku, Kyoto, Kyoto 616-8255, Japan Japan
Telephone 075-461-5121
E-mail sawada@unh.hosp.go.jp
Affiliation Utano National Hospital, National Hospital Organization Clinical Research Institute
scientific contact
Name Hideyuki Sawada
Address 8, Ondoyama, Narutaki, Ukyo-ku, Kyoto, Kyoto 616-8255, Japan Japan
Telephone 075-461-5121
E-mail sawaad@unh.hosp.go.jp
Affiliation Utano National Hospital, National Hospital Organization Clinical Research Institute