NCT01634243

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

A Open-label Dose-ranging Study for SPM 962 in Parkinson's Disease Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 30 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

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: 2005-01-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2012-07-06
• Last updated: 2014-03-19
• Results posted: 2014-03-19

Locations

5 sites across 1 country: Japan