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

Primary Purpose

Restless Legs Syndrome

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Rotigotine

About this trial

This is an interventional treatment trial for Restless Legs Syndrome focused on measuring Idiopathic Restless Leg syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Idiopathic restless legs syndrome Exclusion Criteria: History of sleep disturbances

Sites / Locations

Schwarz

Outcomes

Primary Outcome Measures

IRLS sum score and CGI Item 1 score severity of illness

Secondary Outcome Measures

IRLS Responder: A responder is a subject with a decrease of ≥50% in IRLS sum score

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

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

Full Information

NCT ID

NCT00135993

First Posted

August 24, 2005

Last Updated

September 24, 2014

Sponsor

UCB Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00135993

Brief Title

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

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

UCB Pharma

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Restless Legs Syndrome

Keywords

Idiopathic Restless Leg syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

811 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Rotigotine

Primary Outcome Measure Information:

Title

IRLS sum score and CGI Item 1 score severity of illness

Time Frame

From Baseline at the end of the Maintenance Period

Secondary Outcome Measure Information:

Title

IRLS Responder: A responder is a subject with a decrease of ≥50% in IRLS sum score

Time Frame

From Baseline at the end of the Maintenance Period

Title

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

Time Frame

From Baseline at the end of the Maintenance Period

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Idiopathic restless legs syndrome Exclusion Criteria: History of sleep disturbances

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

UCB Clinical Trial Call Center

Organizational Affiliation

UCB Pharma

Official's Role

Study Director

Facility Information:

Facility Name

Schwarz

City

RTP

State/Province

North Carolina

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20629075

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.

Results Reference

result

PubMed Identifier

26446245

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.

Results Reference

derived

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

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