Clinical Trial: Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: IMPAX Laboratories, Inc.

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: IMPAX Laboratories, Inc.

Dates:
Date Received: January 23, 2012
Date Started: November 2011
Date Completion:
Last Updated: January 31, 2017
Last Verified: January 2017