Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)
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.
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)
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
Conditions
Interventions
- IPX159 Drug
- Placebo Drug
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
- Oct 31, 2011
- Primary completion
- Jan 31, 2013
- Completion
- Jan 31, 2013
- Last update posted
- Jan 31, 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 Jan 31, 2017 · Synced Jun 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01521663 live on ClinicalTrials.gov.