An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease

Idiopathic Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00505687
• Other study ID #: SP0833
• Secondary ID: 2004-002641-12
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2007
• Last updated: September 24, 2014
• Start date: February 2005
• Est. completion date: December 2008

Study information

• Verified date: September 2010
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustria: Agency for Health and Food SafetyItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthIsrael: Ethics CommissionSouth Africa: Department of HealthSpain: Spanish Agency of MedicinesGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 31 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• Rotigotine
Rotigotine transdermal patches: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) Optimal dosing: The maximum rotigotine dose allowed is 16 mg/24 hours.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Israel,  Italy,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With at Least One Adverse Event During This Open-label Extension Study	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.	four years	No
Secondary	Number of Subjects Who Withdrew From the Trial Due to an Adverse Event	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.	four years	No
Secondary	Mean Epworth Sleepiness Scale Score During the Open-label Extension.	The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.	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)	No

External Links

•   FDA Safety Alerts and Recalls
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