A Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With Idiopathic Parkinson's Disease

UCB Pharma0 sites186 target enrollmentFebruary 2005

ConditionsIdiopathic Parkinson's Disease

InterventionsRotigotine

DrugsRotigotine

Overview

Phase: Phase 3
Intervention: Rotigotine
Conditions: Idiopathic Parkinson's Disease
Sponsor: UCB Pharma
Enrollment: 186
Primary Endpoint: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic PD.

Detailed Description

This is the open-label extension to the open-label trials SP824 (NCT00242008), SP825 (NCT00243971), and SP826 (NCT00243945) that assessed the efficacy and safety and tolerability of rotigotine in subjects with idiopathic Parkinson's Disease.

Registry

clinicaltrials.gov

Start Date

February 2005

End Date

December 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

UCB Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who have completed treatment in one of the SP824 (NCT00242008), SP825 (NCT00243971), or SP826 (NCT00243945) trials

Exclusion Criteria

•Subjects who had an ongoing serious adverse event from the previous OLE trial that was assessed as related to study medication

Arms & Interventions

Rotigotine

Intervention: Rotigotine

Outcomes

Primary Outcomes

Number of Subjects With at Least One Adverse Event During This Open-label Extension Study

Time Frame: four years

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Secondary Outcomes

Mean Epworth Sleepiness Scale Score During the Open-label Extension.(Visit 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit))
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event(four years)