Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: November 21, 2005
Last updated: April 15, 2015
Last verified: April 2015
This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.

Condition Intervention Phase
Restless Legs Syndrome
Restless Legs Syndrome (RLS)
Drug: ropinirole controlled-release for RLS
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 4-Week, Randomized, Double-Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting From Ropinirole Immediate Release (IR) to Ropinirole Extended Release (XR) Formulation in Patients With Restless Legs Syndrome (RLS)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • adverse events (AE) post-conversion from ropinirole IR to ropinirole controlled-release for RLS

Secondary Outcome Measures:
  • Proportion discontinuing drug due to AEs after conversion from ropinirole IR to ropinirole controlled-release for RLS, analyses of AEs and vital signs, efficacy parameters(International RLS (IRLS) Rating Scale)

Enrollment: 135
Study Start Date: November 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of RLS using IRLS Study Group (IRLSSG) diagnostic criteria.
  • Subjects currently being treated for RLS with a stable dose (for at least 2 weeks) of ropinirole IR given once daily.
  • Subjects with RLS symptoms during both the evening and night or night time only.
  • Subjects who have given written informed consent to participate.

Exclusion Criteria:

  • Subjects who require treatment of daytime RLS symptoms.
  • Signs of secondary RLS, serum ferritin level less than 10 mcg/L.
  • Movement Disorders, Clinically significant or unstable medical conditions.
  • Abnormal labs, electrocardiogram (ECG) or physical findings.
  • Receiving prohibited medications.
  • Sleeping habits incompatible with study design.
  • Intolerance to ropinirole or other dopamine agonist.
  • Pregnant or lactating.
  • Women of child-bearing potential who are not practicing an acceptable method of birth control.
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Please refer to this study by its identifier: NCT00256854

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Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00256854     History of Changes
Other Study ID Numbers: ROX104805 
Study First Received: November 21, 2005
Last Updated: April 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Restless Legs Syndrome

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on August 24, 2016