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RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00314860
First received: April 13, 2006
Last updated: September 20, 2012
Last verified: June 2012
History of Changes
  Purpose

Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks


Condition Intervention Phase
Restless Legs Syndrome
Restless Legs Syndrome (RLS)
 Drug: ropinirole Extended Release (XR)
 Phase 3

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, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared With Ropinirole Immediate Release (IR) Tablets in Subjects With Restless Legs Syndrome (RLS)

Resource links provided by NLM:

MedlinePlus related topics: Restless Legs
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:
  • To compare the safety profile and to evaluate the clinical benefits (as assessed by efficacy endpoints and patient-reported outcomes) of ropinirole extended release compared to ropinirole immediate release in subjects with RLS. [ Time Frame: 12 Weeks ]

Enrollment: 480
Study Start Date: February 2006
Intervention Details:
    Drug: ropinirole Extended Release (XR)
    Other Name: ropinirole Extended Release (XR)
  Eligibility

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

Inclusion Criteria:

  • Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria.
  • Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment.

Exclusion criteria:

  • Signs of secondary RLS.
  • Primary sleep disorder or movement disorder other than RLS.
  • Unstable medical conditions.
  • Inability to tolerate dopamine agonists or dopamine antagonists.
  • Unwilling to discontinue any medications currently being taken to treat RLS symptoms.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314860

  Show 84 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00314860     History of Changes
Other Study ID Numbers: 101468/204
Study First Received: April 13, 2006
Last Updated: September 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Restless Legs Syndrome

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 May 16, 2013