Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

NCT00135993 | Completed Phase 3

• 1 other identifier: SP0792
• Study Type: interventional
• Target: 811
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial. The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless legs syndrome. Additional objectives are to investigate the safety and tolerability of rotigotine. Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be enrolled in this trial, participating at approximately 60 sites. The maximum duration of the trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).

Conditions

Restless Legs Syndrome

Keywords

Idiopathic Restless Leg syndrome

Outcome Measures

Primary Outcomes (1)

• IRLS sum score and CGI Item 1 score severity of illness

  From Baseline at the end of the Maintenance Period

Secondary Outcomes (3)

• 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

• CGI Item 1 Responder: A responder is defined as a subject with a decrease of ≥50% in CGI Item 1

  From Baseline at the end of the Maintenance Period

• 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

Interventions

Rotigotine DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic restless legs syndrome

You may not qualify if:

• History of sleep disturbances

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (1)

Schwarz

RTP, North Carolina, United States

Location

Related Publications (2)

• Hening WA, Allen RP, Ondo WG, Walters AS, Winkelman JW, Becker P, Bogan R, Fry JM, Kudrow DB, Lesh KW, Fichtner A, Schollmayer E; SP792 Study Group. Rotigotine improves restless legs syndrome: a 6-month randomized, double-blind, placebo-controlled trial in the United States. Mov Disord. 2010 Aug 15;25(11):1675-83. doi: 10.1002/mds.23157.

  PMID: 20629075 RESULT

• Ondo WG, Grieger F, Moran K, Kohnen R, Roth T. Post Hoc Analysis of Data from Two Clinical Trials Evaluating the Minimal Clinically Important Change in International Restless Legs Syndrome Sum Score in Patients with Restless Legs Syndrome (Willis-Ekbom Disease). J Clin Sleep Med. 2016 Jan;12(1):63-70. doi: 10.5664/jcsm.5396.

  PMID: 26446245 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• UCB Clinical Trial Call Center

  UCB Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 24, 2005
• First Posted: August 26, 2005
• Study Start: May 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: September 25, 2014

Record last verified: 2009-09

Locations

US (1)