12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome - Full Text View

12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome ((CR-RLS))

This study has been completed.

First Received on September 7, 2006. Last Updated on March 17, 2011 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00373542

Purpose

The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.

Condition	Intervention	Phase
Restless Legs Syndrome	Drug: ropinirole CR-RLS	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients With Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep

Resource links provided by NLM:

MedlinePlus related topics: Restless Legs Sleep Disorders

Drug Information available for: Ropinirole hydrochloride Ropinirole

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12. [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:

Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes. [ Time Frame: 12 Weeks ]

Enrollment:	216
Study Start Date:	October 2006

Intervention Details:

Other Name: ropinirole CR-RLS

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

provided written informed consent.
Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.
Sleep efficiency <85% OR Latency to persistent sleep >20 minutes.

Exclusion criteria:

Secondary RLS
Primary sleep disorder
Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
Use of any prohibited medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373542

Show 38 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00373542 History of Changes
Other Study ID Numbers:	RRL103660
Study First Received:	September 7, 2006
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

polysomnography
Restless Legs Syndrome
ropinirole
PSG
RLS

Additional relevant MeSH terms:

Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations

Signs and Symptoms
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012