NCT01628848

A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients

A Placebo-controlled Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 30 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	SPM 962	SPM 962 transdermal patch once a daily up to 36.0 mg/day
DRUG	Placebo	Placebo transdermal patch

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2012-06-27
• Last updated: 2014-03-19
• Results posted: 2014-03-19

Locations

7 sites across 1 country: Japan