Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects

Idiopathic Restless Legs Syndrome Clinical Trial

Official title:

An Open-label Extension Trial to Investigate the Safety and Tolerability of Long-term Treatment With Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498108
• Other study ID #: SP0791
• Secondary ID: EudraCT Number:
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2007
• Last updated: September 24, 2014
• Start date: January 2006
• Est. completion date: September 2007

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustria: Agency for Health and Food SafetyFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open-label trial to assess safety and tolerability of rotigotine in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year in subjects who previously participated in SP790 (6-month pivotal trial) or SP794 (sleep lab trial). Subjects who successfully completed the Maintenance Period and the Taper Period of SP790 or SP794 are allowed to enroll in this trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subject completed the Maintenance Period and Taper Period of SP790 or SP794

Exclusion Criteria:

• Subject has an ongoing serious adverse event (SAE) from SP790 or SP794 that is assessed to be related to the trial medication by the investigator and/or the sponsor.

• Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Restless Legs Syndrome
• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• Rotigotine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, changes in laboratory tests, vital signs, physical and neurological examination, menstrual and sexual function, 12-lead ECGs. Subject's rating of daytime sleepiness, global subject rating of tolerability
Secondary	Change in the International Restless Legs Scale (IRLS) sum score, in CGI Items 1 and 2-3, in RLS-6 Rating Scales. IRLS Responder		from Baseline at the end of the Maintenance Period

External Links

•   Clinical Study Summary on UCB.com