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Transdermal Lisuride: a Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)

Primary Purpose

Restless Legs Syndrome

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Lisuride
Ropinirole
Placebo
Sponsored by
Axxonis Pharma AG
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Legs Syndrome focused on measuring Restless Legs Syndrome, dopamine agonist, lisuride, ropinirole

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Idiopathic or uremic RLS RLS Diagnostic Index (RLS-DI) > 10 Total score in the IRLS Rating Scale ≥ 15 at baseline No previous treatment for RLS or insufficient current therapy Exclusion Criteria: Secondary RLS, e.g. due to iron deficiency (exception: uremia) History or presence of sleep disorders other than RLS

Sites / Locations

  • IMEREM GmbH

Outcomes

Primary Outcome Measures

International Restless Legs Severity Scale (IRLS)

Secondary Outcome Measures

RLS-6 scales
CGI

Full Information

First Posted
August 22, 2006
Last Updated
March 6, 2012
Sponsor
Axxonis Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT00367822
Brief Title
Transdermal Lisuride: a Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)
Official Title
Transdermal Lisuride: a Double-blind, Randomized, Active- and Placebo-controlled Multi-centre Phase III Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
Axxonis Pharma AG

4. Oversight

5. Study Description

Brief Summary
The objective of this trial is to compare an individually optimized dose of the lisuride TTS patch against placebo and against an individually optimized dose of oral ropinirole (active- and placebo-controlled design) in idiopathic and uremic RLS patients with regard to efficacy, safety, and quality of life.
Detailed Description
Approximately 300 patients will be randomized to receive either lisuride, ropinirole or placebo in a 2:1:1 fashion. After completion of 12 weeks of double-blind treatment, eligible patients will have the option to continue treatment with the lisuride patch for further 36 weeks in an open-label extension of the study. Primary outcome: Changes in the total score of the International Restless Legs Severity Scale (IRLS) from baseline to end of double-blind treatment (12 weeks) will be used as primary efficacy outcome measure. Secondary objectives are to evaluate quality of life, safety and tolerability. After the double-blind period, long-term efficacy of lisuride will be assessed for further 36 weeks in an open-label extension of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome
Keywords
Restless Legs Syndrome, dopamine agonist, lisuride, ropinirole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lisuride
Intervention Type
Drug
Intervention Name(s)
Ropinirole
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
International Restless Legs Severity Scale (IRLS)
Secondary Outcome Measure Information:
Title
RLS-6 scales
Title
CGI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic or uremic RLS RLS Diagnostic Index (RLS-DI) > 10 Total score in the IRLS Rating Scale ≥ 15 at baseline No previous treatment for RLS or insufficient current therapy Exclusion Criteria: Secondary RLS, e.g. due to iron deficiency (exception: uremia) History or presence of sleep disorders other than RLS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heike Benes, MD
Organizational Affiliation
Somnibene GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
IMEREM GmbH
City
Nuremberg
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Transdermal Lisuride: a Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)

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