Specified Drug Use-Results Survey of Regnite
Completed
- Conditions
- Restless Legs Syndrome
- Interventions
- Drug: Regnite
- Registration Number
- NCT01887613
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
This study is to investigate the long-term safety and efficacy and the information on the proper use of Regnite® under conditions of daily clinical use.
- Detailed Description
Sleeping condition and severity of restless legs syndrome (RLS) were recorded at the start and during the treatment. The treatment period is scheduled to last 52 weeks in principle. For patients completing or discontinuing the use of Regnite® within 52 weeks, follow up on the withdrawal and rebound syndrome will be conducted up to 4 weeks of completion or discontinuation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1597
Inclusion Criteria
- Patients with moderate to severe idiopathic restless legs syndrome
Exclusion Criteria
- Patients with a history of hypersensitivity to any ingredients in Regnite or gabapentin
- Patients with severely impaired renal function (creatinine clearance of less than 30 mL/min)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Regnite group Regnite Patients who receive Regnite
- Primary Outcome Measures
Name Time Method Safety such as occurrence of adverse drug reactions and lab-tests Up to 52 weeks
- Secondary Outcome Measures
Name Time Method Clinical Global Impression Baseline and at 52 weeks Restless Leg Syndrome score Baseline and at 52 weeks