A Dose-ranging Study for SPM 962 in Parkinson's Disease Patients
The primary objective of this trial is to establish the maximum maintenance dose of SPM 962 in patients with Parkinson's disease in a multi-center, uncontrolled, open-label study by conducting safety evaluation of each patient following once-daily transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg. (The administration period will consist of a standard 8-week dose-titration period, 4-week dose-maintenance period, and a dose de-escalation period) Exploratory evaluation of each patient's maintenance dose will also be conducted with attention to patient safety. The relationship of pharmacokinetics, safety, and efficacy will also be examined.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Open-label Dose-ranging Study for SPM 962 in Parkinson's Disease Patients|
- maintenance dose of the SPM962 [ Time Frame: Up to 12 weeks after dosing ] [ Designated as safety issue: Yes ]The maintenance dose of the SPM 962 was examined based on the safety and efficacy.
- incidence and severity of adverse events, vital signs, and laboratory parameters [ Time Frame: Up to 12 weeks after dosing ] [ Designated as safety issue: Yes ]
- Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 sum score and Part 3 sum score for early Parkinson's disease without concomitant L-dopa therapy [ Time Frame: baseline, 12 weeks after dosing ] [ Designated as safety issue: No ]Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum at 12 weeks after dosing.
- UPDRS Part 3 sum score for advanced Parkinson's disease with concomitant L-dopa therapy [ Time Frame: baseline, 12 weeks after dosing ] [ Designated as safety issue: No ]Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing.
|Study Start Date:||January 2005|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
Experimental: SPM 962
SPM 962 transdermal patch
Drug: SPM 962
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Other Name: rotigotine
|Kanto Region, Japan|
|Kinki Region, Japan|
|Kyushu Region, Japan|
|Shikoku Region, Japan|
|Tohoku Region, Japan|
|Study Director:||Kyoji Imaoka, Mr||Otsuka Pharmaceutical Co., Ltd.|