Status:
COMPLETED
Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Restless Legs Syndrome
Restless Legs Syndrome (RLS)
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 14 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2006
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00256854
Start Date
November 14 2005
End Date
September 21 2006
Last Update
March 15 2019
Active Locations (30)
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1
GSK Investigational Site
Laguna Hills, California, United States, 82653
2
GSK Investigational Site
Oxnard, California, United States, 93030
3
GSK Investigational Site
Pasadena, California, United States, 91106
4
GSK Investigational Site
Reseda, California, United States, 91355