NCT01628926

A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients

A Double-Blind, 3-Arm, Parallel Group, Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 30 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

* To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in order to confirm clinical value of SPM 962. * To demonstrate the superiority of SPM 962 to placebo in terms of efficacy. * To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day.

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	Ropinirole	Ropinirole oral administration TID up to 15.0 mg/day
DRUG	Placebo	SPM962-placebo patch and Ropinirole-placebo tab

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2012-06-27
• Last updated: 2014-05-23
• Results posted: 2014-05-23

Locations

8 sites across 1 country: Japan