Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)
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|ClinicalTrials.gov Identifier: NCT01521663|
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : February 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Restless Legs Syndrome||Drug: IPX159 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||159 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of IPX159 in the Treatment of Moderate to Severe Restless Legs Syndrome (RLS)|
|Study Start Date :||November 2011|
|Primary Completion Date :||February 2013|
|Study Completion Date :||February 2013|
IPX159 90 mg daily at week 1 with titration to 180 mg daily at week 2 with possible titration to 270 mg daily at week 3.
Placebo Comparator: Sugar Pill
IPX159 90 mg matching placebo daily at week 1 with titration to 180 mg matching placebo daily at week 2.
- International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale [ Time Frame: Assessed at each study visit (visits 1-7), an expected average of 11 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521663
Show 38 Study Locations
|Principal Investigator:||Impax Study Director||Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)|