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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT01521663

Public ClinicalTrials.gov record NCT01521663. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 2:02 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01521663
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Impax Laboratories, LLC
Industry
Enrollment
159 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2011 (Type not available)
Primary completion
Feb 2013 (Actual)
Completion
Feb 2013 (Actual)
Last update posted
Feb 1, 2017

2011 – 2013

United States locations

U.S. sites
38
U.S. states
20
U.S. cities
37
Facility City State ZIP Site status
University of Alabama at Birmingham Brimingham Alabama 35294 —
Preferred Research Partners, Inc. Little Rock Arkansas 72211 —
Scripps Clinic La Jolla California 92037 —
Collaborative Neuroscience Network, Inc. Long Beach California 90806 —
The Research Center of Southern California Oceanside California 92056 —
Stanford Center for Human Sleep Research Redwood City California 94063 —
Neurological Research Institute Santa Monica California 90404 —
Sleep-Alertness Disorder Center Aurora Colorado 80012 —
PAB Clinical Research Brandon Florida 33511 —
MD Clinical Hallandale Florida 33009 —
Neurology Associates of Ormond Beach Ormond Beach Florida 32174 —
Resurgence Group Palm Harbor Florida 34684 —
NeuroTrials Research Inc Atlanta Georgia 30342 —
Georgia Health Sciences University Augusta Georgia 30912 —
SleepMed of Central Georgia Macon Georgia 31201 —
University of Iowa Hospitals and Clinics Iowa City Iowa 52242 —
Community Research Crestview Hills Kentucky 41017 —
Kentucky Research Group Louisville Kentucky 40217 —
Johns Hopkins Bayview Medical Center Campus Baltimore Maryland 21224 —
Sleep Health Centers, LLC Brighton Massachusetts 02135 —
Beacon Clinical Research, LLC Brockton Massachusetts 02301 —
QUEST Research Institute Farmington Hills Michigan 48334 —
Global Medical Institutes, LLC Princeton New Jersey 08540 —
Fieve Clinical Research, Inc. New York New York 10168 —
Comprehensive Multiple Sclerosis Care Center Patchogue New York 11772 —
Raleigh Neurology Associates, P.A. Raleigh North Carolina 27607 —
Wake Research Associates, LLC Raleigh North Carolina 27612 —
PMG Research of Wilmington, LLC Wilmington North Carolina 28401 —
Community Research Cincinnati Ohio 45255 —
Sleep Lab of Northeastern Pennsylvania Clarks Summit Pennsylvania 18411 —
SleepMed of SC Columbia South Carolina 29201 —
Coastal Carolina Research Center Mt. Pleasant South Carolina 29464 —
University of Tennesee Health Science Center Memphis Tennessee 38163 —
Future Research Trials of Neurology Austin Texas 78731 —
Clinical Trial Network Houston Texas 77074 —
Bhupesh Dihenia, M.D., P.A. Lubbock Texas 79410 —
Paragon Research Center, LLC San Antonio Texas 78205 —
Sleep Medicine Associates Seattle Washington 98122 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01521663, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 1, 2017 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01521663 live on ClinicalTrials.gov.

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