Trials / Completed
CompletedNCT01521663
Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)
A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of IPX159 in the Treatment of Moderate to Severe Restless Legs Syndrome (RLS)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 159 (actual)
- Sponsor
- Impax Laboratories, LLC · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether IPX159 is safe and effective in treating symptoms of RLS in subjects with Restless Legs Syndrome.
Detailed description
IPX159 was developed as an extended release formulation to reduce the fluctuation in nefopam concentration compared to IR and to reduce the incidence of peak or rate related side effects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IPX159 | |
| DRUG | Placebo |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2013-02-01
- Completion
- 2013-02-01
- First posted
- 2012-01-31
- Last updated
- 2017-02-01
Locations
38 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01521663. Inclusion in this directory is not an endorsement.