Clinical trial NCT00135993: Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Five-Arm Parallel-Group Trial to Investigate the Efficacy and Safety of Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Restless Legs Syndrome
Keywords: Idiopathic Restless Leg syndrome
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-08-26
Enrollment: 811
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* Idiopathic restless legs syndrome

Exclusion Criteria:

* History of sleep disturbances

Primary outcomes:
measure: IRLS sum score and CGI Item 1 score severity of illness
timeFrame: From Baseline at the end of the Maintenance Period
Secondary outcomes:
measure: IRLS Responder: A responder is a subject with a decrease of ≥50% in IRLS sum score
timeFrame: From Baseline at the end of the Maintenance Period
measure: CGI Item 1 Responder: A responder is defined as a subject with a decrease of ≥50% in CGI Item 1
timeFrame: From Baseline at the end of the Maintenance Period
measure: 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
Other outcomes:
Locations:
city: RTP
country: United States
facility: Schwarz
state: North Carolina
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.