Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)
- Registration Number
- NCT01521663
- Lead Sponsor
- Impax Laboratories, LLC
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 159
- 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.
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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
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History of HIV, hepatitis B or C
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Pregnant or breastfeeding.
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History of or clinical signs of any form of epilepsy or seizures, excluding fever-related seizures in childhood.
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History or presence of glaucoma
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Planning to take herbal medications (eg, hypericum perforatum [St John's Wort], licorice, ephedra, ginkgo, ginseng) during the study.
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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
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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
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Employees or family members of the Investigator, study site, the Sponsor, or Contract Research Organization (if any)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IPX159 IPX159 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. Sugar Pill Placebo IPX159 90 mg matching placebo daily at week 1 with titration to 180 mg matching placebo daily at week 2.
- Primary Outcome Measures
Name Time Method International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale Assessed at each study visit (visits 1-7), an expected average of 11 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
University of Alabama at Birmingham
🇺🇸Brimingham, Alabama, United States
Preferred Research Partners, Inc.
🇺🇸Little Rock, Arkansas, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Collaborative Neuroscience Network, Inc.
🇺🇸Long Beach, California, United States
The Research Center of Southern California
🇺🇸Oceanside, California, United States
Neurological Research Institute
🇺🇸Santa Monica, California, United States
Stanford Center for Human Sleep Research
🇺🇸Redwood City, California, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
Neurology Associates of Ormond Beach
🇺🇸Ormond Beach, Florida, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Resurgence Group
🇺🇸Palm Harbor, Florida, United States
Georgia Health Sciences University
🇺🇸Augusta, Georgia, United States
NeuroTrials Research Inc
🇺🇸Atlanta, Georgia, United States
SleepMed of Central Georgia
🇺🇸Macon, Georgia, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Kentucky Research Group
🇺🇸Louisville, Kentucky, United States
Beacon Clinical Research, LLC
🇺🇸Brockton, Massachusetts, United States
Global Medical Institutes, LLC
🇺🇸Princeton, New Jersey, United States
Sleep Health Centers, LLC
🇺🇸Brighton, Massachusetts, United States
Johns Hopkins Bayview Medical Center Campus
🇺🇸Baltimore, Maryland, United States
QUEST Research Institute
🇺🇸Farmington Hills, Michigan, United States
Fieve Clinical Research, Inc.
🇺🇸New York, New York, United States
Comprehensive Multiple Sclerosis Care Center
🇺🇸Patchogue, New York, United States
Sleep Lab of Northeastern Pennsylvania
🇺🇸Clarks Summit, Pennsylvania, United States
PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
Raleigh Neurology Associates, P.A.
🇺🇸Raleigh, North Carolina, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
SleepMed of SC
🇺🇸Columbia, South Carolina, United States
Coastal Carolina Research Center
🇺🇸Mt. Pleasant, South Carolina, United States
Future Research Trials of Neurology
🇺🇸Austin, Texas, United States
University of Tennesee Health Science Center
🇺🇸Memphis, Tennessee, United States
Bhupesh Dihenia, M.D., P.A.
🇺🇸Lubbock, Texas, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
Paragon Research Center, LLC
🇺🇸San Antonio, Texas, United States
Sleep Medicine Associates
🇺🇸Seattle, Washington, United States
Sleep-Alertness Disorder Center
🇺🇸Aurora, Colorado, United States
Community Research
🇺🇸Cincinnati, Ohio, United States