Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome

Restless Legs Syndrome Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Placebo-controlled, Four-arm Parallel-group Trial to Investigate the Efficacy and Safety of Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136045
• Other study ID #: SP0790
• Secondary ID: 2005-000428-18
• Status: Completed
• Phase: Phase 3
• First received: August 24, 2005
• Last updated: September 24, 2014
• Start date: May 2005
• Est. completion date: August 2006

Study information

• Verified date: February 2010
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless leg syndrome (RLS). Additional objectives are to investigate the safety and tolerability of rotigotine.

The primary variables are the absolute change from Baseline in the International Restless Legs Severity Scale (IRLS) sum score and Clinical Global Impression-Global Improvement (CGI) Item 1 (severity of illness) score at the end of the Maintenance Period.

Subjects will be randomized to receive either placebo, 2.25, 4.5 or 6.75 mg/day rotigotine in a 1:1:1:1 (active:placebo) fashion. Approximately 450 subjects will be enrolled in this trial, participating at approximately 50 sites. The maximum duration of the trial is approximately 8 months (3-week Titration Period, 6-month Maintenance Period, 7-day Taper Period, and 30-day Safety Follow-Up Period). Subjects who complete the 6-month Maintenance Period will be eligible to participate in an open-label extension trial. Subjects who do not complete the 6-month Maintenance Period or who choose not to participate in the open-label extension trial will complete a 3-day Safety Follow-Up Period. Two different patch sizes will be used (5 and 10 cm2). Active patches will contain either 2.25mg (5cm2) or 4.5mg (10cm2) of rotigotine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 549
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Idiopathic RLS

Exclusion Criteria:

• History of sleep disturbances

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• Rotigotine

Locations

Country	Name	City	State
Germany	Schwarz	Monheim

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Trenkwalder C, Benes H, Poewe W, Oertel WH, Garcia-Borreguero D, de Weerd AW, Ferini-Strambi L, Montagna P, Odin P, Stiasny-Kolster K, Högl B, Chaudhuri KR, Partinen M, Schollmayer E, Kohnen R; SP790 Study Group. Efficacy of rotigotine for treatment of mo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IRLS sum score and CGI Item 1 score severity of illness		From Baseline at the end of the Maintenance Period
Secondary	IRLS Responder: A responder is a subject with a decrease of =50% in IRLS sum score from Baseline at the end of the Maintenance Period
Secondary	Changes in CGI Items 2-3 (continuous) during the Maintenance Period; Change from Baseline in RLS-6 Rating Scales at the end of the Maintenance Period
Secondary	CGI Item 1 Responder: A responder is a subject with a decrease of =50% in CGI Item 1 at the end of the Maintenance Period

External Links

•   Clinical Study Summary on UCB.com