Trials / Completed
CompletedNCT00666965
A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients
A Placebo-Controlled Study for SPM 962 in RLS Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 230 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 79 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to investigate efficacy and safety of SPM 962 in Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group comparative study following once-daily multiple transdermal doses of SPM 962 within a range of 2.25 to 6.75 mg/day. Recommended maintainance dose range is also to be investigated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPM 962 | transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2009-08-01
- Completion
- 2009-08-01
- First posted
- 2008-04-25
- Last updated
- 2014-04-25
- Results posted
- 2014-04-25
Locations
8 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00666965. Inclusion in this directory is not an endorsement.