Specified Drug Use-Results Survey of Regnite
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Specified Drug Use-Results Survey of Regnite|
- Safety such as occurrence of adverse drug reactions and lab-tests [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
- Restless Leg Syndrome score [ Time Frame: Baseline and at 52 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impression [ Time Frame: Baseline and at 52 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Patients who receive Regnite
Other Name: gabapentin enacarbil
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.
|Contact: Clinical Development Administrationfirstname.lastname@example.org|
|Study Chair:||Use Central Contact||Astellas Pharma Inc|