Status:
COMPLETED
Specified Drug Use-Results Survey of Regnite
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
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 compl...
Eligibility Criteria
Inclusion
- Patients with moderate to severe idiopathic restless legs syndrome
Exclusion
- 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)
Key Trial Info
Start Date :
October 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2019
Estimated Enrollment :
1597 Patients enrolled
Trial Details
Trial ID
NCT01887613
Start Date
October 1 2012
End Date
February 28 2019
Last Update
April 29 2019
Active Locations (7)
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1
Chūbu, Japan
2
Hokkaido, Japan
3
Kansai, Japan
4
Kantou, Japan