Trials / Completed
CompletedNCT01887613
Specified Drug Use-Results Survey of Regnite
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,597 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Regnite | oral |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2019-02-28
- Completion
- 2019-02-28
- First posted
- 2013-06-27
- Last updated
- 2019-04-29
Locations
7 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01887613. Inclusion in this directory is not an endorsement.