NCT01631812

A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients

An Open-label Long-term Extension Trial From Late Phase II of SPM962 (243-05-001) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to investigate safety of SPM 962 in advanced PD patients in a multi-center, open-label, non-controlled study following once-daily multiple transdermal doses of SPM962 within a range of 4.5 to 36.0 mg (maximum treatment period: 54 weeks). Efficacy is also to be exploratory investigated.

Conditions

• Parkinson's Disease

Interventions

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

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2012-06-29
• Last updated: 2014-03-19
• Results posted: 2014-03-19

Locations

7 sites across 1 country: Japan