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)
1 other identifier
interventional
159
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2011
Shorter than P25 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 23, 2012
CompletedFirst Posted
Study publicly available on registry
January 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFebruary 1, 2017
January 1, 2017
1.3 years
January 23, 2012
January 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale
Assessed at each study visit (visits 1-7), an expected average of 11 weeks
Study Arms (2)
IPX159
EXPERIMENTALIPX159 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.
Sugar Pill
PLACEBO COMPARATORIPX159 90 mg matching placebo daily at week 1 with titration to 180 mg matching placebo daily at week 2.
Interventions
Eligibility Criteria
You may qualify if:
- Able to understand and willing to sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Males and females aged 18-70 with a history of primary RLS for ≥6 months prior to screening
- Symptoms of RLS by medical history on at least 15 nights during the month prior to Screening
- BMI 18.5-32
- Negative alcohol and drug abuse screen
- Negative serum pregnancy test
- Agrees to use a medically acceptable method of contraception throughout the study and for 2 months after completing the study.
- Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.
You may not qualify if:
- Subjects who use or intend to use post screening the following medications or medication categories:
- Sedative hypnotics, trazodone
- Dopamine agonists, gabapentin, gabapentin enacarbil, pregabalin
- Narcotic analgesics, other opioids, tramadol, cyclobenzaprine
- Iron supplementation therapy
- History of HIV, hepatitis B or C
- Pregnant or breastfeeding.
- History of or clinical signs of any form of epilepsy or seizures, excluding fever-related seizures in childhood.
- History or presence of glaucoma
- Planning to take herbal medications (eg, hypericum perforatum \[St John's Wort\], licorice, ephedra, ginkgo, ginseng) during the study.
- Use of any investigational drug within the last 30 days or within a period of 5 times the drug's half-life, whichever is longer
- Subjects who, in the opinion of the Investigator, should not participate in the study or are not capable of following the study schedule for any reason
- Employees or family members of the Investigator, study site, the Sponsor, or Contract Research Organization (if any)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
University of Alabama at Birmingham
Brimingham, Alabama, 35294, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211, United States
Scripps Clinic
La Jolla, California, 92037, United States
Collaborative Neuroscience Network, Inc.
Long Beach, California, 90806, United States
The Research Center of Southern California
Oceanside, California, 92056, United States
Stanford Center for Human Sleep Research
Redwood City, California, 94063, United States
Neurological Research Institute
Santa Monica, California, 90404, United States
Sleep-Alertness Disorder Center
Aurora, Colorado, 80012, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
MD Clinical
Hallandale, Florida, 33009, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174, United States
Resurgence Group
Palm Harbor, Florida, 34684, United States
NeuroTrials Research Inc
Atlanta, Georgia, 30342, United States
Georgia Health Sciences University
Augusta, Georgia, 30912, United States
SleepMed of Central Georgia
Macon, Georgia, 31201, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Community Research
Crestview Hills, Kentucky, 41017, United States
Kentucky Research Group
Louisville, Kentucky, 40217, United States
Johns Hopkins Bayview Medical Center Campus
Baltimore, Maryland, 21224, United States
Sleep Health Centers, LLC
Brighton, Massachusetts, 02135, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, 02301, United States
QUEST Research Institute
Farmington Hills, Michigan, 48334, United States
Global Medical Institutes, LLC
Princeton, New Jersey, 08540, United States
Fieve Clinical Research, Inc.
New York, New York, 10168, United States
Comprehensive Multiple Sclerosis Care Center
Patchogue, New York, 11772, United States
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, 27607, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Community Research
Cincinnati, Ohio, 45255, United States
Sleep Lab of Northeastern Pennsylvania
Clarks Summit, Pennsylvania, 18411, United States
SleepMed of SC
Columbia, South Carolina, 29201, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
University of Tennesee Health Science Center
Memphis, Tennessee, 38163, United States
Future Research Trials of Neurology
Austin, Texas, 78731, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Bhupesh Dihenia, M.D., P.A.
Lubbock, Texas, 79410, United States
Paragon Research Center, LLC
San Antonio, Texas, 78205, United States
Sleep Medicine Associates
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Impax Study Director
Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2012
First Posted
January 31, 2012
Study Start
November 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
February 1, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share