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

NCT ID: NCT00136045

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 549 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2006-08-31

Brief 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.

Conditions

Restless Legs Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Rotigotine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Idiopathic RLS

Exclusion Criteria

• History of sleep disturbances

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Locations

Schwarz

Monheim, , Germany

Countries

Germany

References

Trenkwalder C, Benes H, Poewe W, Oertel WH, Garcia-Borreguero D, de Weerd AW, Ferini-Strambi L, Montagna P, Odin P, Stiasny-Kolster K, Hogl B, Chaudhuri KR, Partinen M, Schollmayer E, Kohnen R; SP790 Study Group. Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2008 Jul;7(7):595-604. doi: 10.1016/S1474-4422(08)70112-1.

Reference Type: RESULT

PMID: 18515185 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26446245 (View on PubMed)

Allen R, Oertel W, Walters A, Benes H, Schollmayer E, Grieger F, Moran K, Kohnen R. Relation of the International Restless Legs Syndrome Study Group rating scale with the Clinical Global Impression severity scale, the restless legs syndrome 6-item questionnaire, and the restless legs syndrome-quality of life questionnaire. Sleep Med. 2013 Dec;14(12):1375-80. doi: 10.1016/j.sleep.2013.09.008. Epub 2013 Oct 18.

Reference Type: DERIVED

PMID: 24246378 (View on PubMed)

Other Identifiers

2005-000428-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP0790

Identifier Type: -

Identifier Source: org_study_id