Specified Drug Use-Results Survey of Regnite

• Status: Completed
• Trial end date: 2019-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Gabapentin

Criteria

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)