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A Placebo-controlled Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa
The primary objective of this study is to investigate efficacy and safety of SPM 962 in advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12 weeks of dose titration/maintenance period). Recommended maintenance dose range is also to be investigated with distribution of the maintenance dose and accumulated response rate of efficacy.
Details
| Lead sponsor | Otsuka Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 174 |
| Start date | 2006-08 |
| Completion | 2008-04 |
Conditions
- Parkinson's Disease
Interventions
- SPM 962
- Placebo
Primary outcomes
- Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score — baseline, 12 weeks after dosing
Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing. UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.
Countries
Japan