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

Completed · Phase 2 · Has a placebo group

Conditions studied: Restless Legs Syndrome

In brief

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.

Key facts

Study ID

NCT01521663

Run by

Impax Laboratories, LLC

People needed

159

Starts

2011-11-01

Expected to finish

2013-02-01

Last updated by the study team

2017-02-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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