Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)
Status: | Completed |
---|---|
Conditions: | Restless Leg Syndrome, Neurology |
Therapuetic Areas: | Neurology, Rheumatology |
Healthy: | No |
Age Range: | 18 - 79 |
Updated: | 3/17/2019 |
Start Date: | November 14, 2005 |
End Date: | September 21, 2006 |
A 4-Week, Randomized, Double-Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting From Ropinirole Immediate Release (IR) to Ropinirole Controlled Release for RLS (CR-RLS) Formulation (Formerly Ropinirole Extended Release [XR]) in Patients With Restless Legs Syndrome (RLS)
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.
dose conversion recommendations for RLS subjects converting from ropinirole immediate release
to ropinirole controlled-release for RLS.
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.
We found this trial at
30
sites
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