Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)
NCT ID: NCT01521663
Last Updated: 2017-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
159 participants
INTERVENTIONAL
2011-11-30
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
IPX159
Sugar Pill
IPX159 90 mg matching placebo daily at week 1 with titration to 180 mg matching placebo daily at week 2.
Placebo
Interventions
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IPX159
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Males and females aged 18-70 with a history of primary RLS for ≥6 months prior to screening
3. Symptoms of RLS by medical history on at least 15 nights during the month prior to Screening
4. BMI 18.5-32
5. Negative alcohol and drug abuse screen
6. Negative serum pregnancy test
7. Agrees to use a medically acceptable method of contraception throughout the study and for 2 months after completing the study.
8. Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.
Exclusion Criteria
* Sedative hypnotics, trazodone
* Dopamine agonists, gabapentin, gabapentin enacarbil, pregabalin
* Narcotic analgesics, other opioids, tramadol, cyclobenzaprine
* Iron supplementation therapy
2. History of HIV, hepatitis B or C
3. Pregnant or breastfeeding.
4. History of or clinical signs of any form of epilepsy or seizures, excluding fever-related seizures in childhood.
5. History or presence of glaucoma
6. Planning to take herbal medications (eg, hypericum perforatum \[St John's Wort\], licorice, ephedra, ginkgo, ginseng) during the study.
7. 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
8. 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
9. Employees or family members of the Investigator, study site, the Sponsor, or Contract Research Organization (if any)
18 Years
70 Years
ALL
No
Sponsors
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Impax Laboratories, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Impax Study Director
Role: PRINCIPAL_INVESTIGATOR
Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)
Locations
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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
Stanford Center for Human Sleep Research
Redwood City, California, United States
Neurological Research Institute
Santa Monica, California, United States
Sleep-Alertness Disorder Center
Aurora, Colorado, United States
PAB Clinical Research
Brandon, Florida, United States
MD Clinical
Hallandale, Florida, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States
Resurgence Group
Palm Harbor, Florida, United States
NeuroTrials Research Inc
Atlanta, Georgia, United States
Georgia Health Sciences University
Augusta, Georgia, United States
SleepMed of Central Georgia
Macon, Georgia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Community Research
Crestview Hills, Kentucky, United States
Kentucky Research Group
Louisville, Kentucky, United States
Johns Hopkins Bayview Medical Center Campus
Baltimore, Maryland, United States
Sleep Health Centers, LLC
Brighton, Massachusetts, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
Global Medical Institutes, LLC
Princeton, New Jersey, United States
Fieve Clinical Research, Inc.
New York, New York, United States
Comprehensive Multiple Sclerosis Care Center
Patchogue, New York, United States
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Community Research
Cincinnati, Ohio, United States
Sleep Lab of Northeastern Pennsylvania
Clarks Summit, Pennsylvania, United States
SleepMed of SC
Columbia, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
University of Tennesee Health Science Center
Memphis, Tennessee, United States
Future Research Trials of Neurology
Austin, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Bhupesh Dihenia, M.D., P.A.
Lubbock, Texas, United States
Paragon Research Center, LLC
San Antonio, Texas, United States
Sleep Medicine Associates
Seattle, Washington, United States
Countries
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Other Identifiers
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IPX159-B11-02
Identifier Type: -
Identifier Source: org_study_id
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