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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by IMPAX Laboratories, Inc.
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT01521663
First received: January 23, 2012
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to purpose of this study is to determine whether IPX159 is safe and effective in treating symptoms of RLS in subjects with Restless Legs Syndrome.


Condition Intervention Phase
Restless Legs Syndrome
Drug: IPX159
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by IMPAX Laboratories, Inc.:

Primary Outcome Measures:
  • International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale [ Time Frame: Assessed at each study visit (visits 1-7), an expected average of 11 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: November 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPX159 Drug: IPX159
Placebo Comparator: Sugar Pill Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to understand and willing to sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization
  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:

  1. Subjects who use or intend to use post screening the following medications or medication categories:

    • Sedative hypnotics, trazodone
    • Dopamine agonists, gabapentin, gabapentin encarbil, 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 CRO (if any)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521663

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Brimingham, Alabama, United States, 35294
Contact: IPX159-B11-02 Study Coordinator    205-934-0683      
United States, Arkansas
Preferred Research Partners, Inc. Recruiting
Little Rock, Arkansas, United States, 72211
Contact: IPX159-B11-02 Study Coordinator    501-553-9987 ext 104      
United States, California
Scripps Clinic Recruiting
La Jolla, California, United States, 92037
Contact: IPX159-B11-02 Study Coordinator    858-554-8895      
Collaborative Neuroscience Network, Inc. Recruiting
Long Beach, California, United States, 90806
Contact: IPX159-B11-02 Study Coordinator    866-787-4257      
The Research Center of Southern California Recruiting
Oceanside, California, United States, 92056
Contact: IPX159-B11-02 Study Coordinator    760-732-0557      
Stanford Center for Human Sleep Research Recruiting
Redwood City, California, United States, 94063
Contact: IPX159-B11-02 Study Coordinator    650-721-7552      
Neurological Research Institute Recruiting
Santa Monica, California, United States, 90404
Contact: IPX159-B11-02 Study Coordinator    310-315-1456      
United States, Colorado
Sleep-Alertness Disorder Center Recruiting
Aurora, Colorado, United States, 80012
Contact: IPX159-B11-02 Study Coordinator    303-671-0977      
United States, Florida
PAB Clinical Research Recruiting
Brandon, Florida, United States, 33511
Contact: IPX159-B11-02 Study Coordinator    813-657-1584 ext 252      
MD Clinical Recruiting
Hallandale Beach, Florida, United States, 33009
Contact: IPX159-B11-02 Study Coordinator    954-455-5757      
Neurology Associates of Ormond Beach Recruiting
Ormond Beach, Florida, United States, 32174
Contact: IPX159-B11-02 Study Coordinator    386-673-2500      
Resurgence Group Recruiting
Palm Harbor, Florida, United States, 34684
Contact: IPX159-B11-02 Study Coordinator    727-647-4515      
United States, Georgia
NeuroTrials Research Inc Recruiting
Atlanta, Georgia, United States, 30342
Contact: IPX159-B11-02 Study Coordinator    404-851-9934      
Georgia Health Sciences University Recruiting
Augusta, Georgia, United States, 30912
Contact: IPX159-B11-02 Study Coordinator    706-721-2798      
SleepMed of Central Georgia Recruiting
Macon, Georgia, United States, 31201
Contact: IPX159-B11-02 Study Coordinator    478-745-9050      
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: IPX159-B11-02 Study Coordinator    319-356-3813      
United States, Kentucky
Community Research Recruiting
Crestview Hills, Kentucky, United States, 41017
Contact: IPX159-B11-02 Study Coordinator    859-331-2584      
Kentucky Research Group Recruiting
Louisville, Kentucky, United States, 40217
Contact: IPX159-B11-02 Study Coordinator    502-479-1217      
United States, Maryland
Johns Hopkins Bayview Medical Center Campus Recruiting
Baltimore, Maryland, United States, 21224
Contact: IPX159-B11-02 Study Coordinator    410-550-2609      
United States, Massachusetts
Sleep Health Centers, LLC Recruiting
Brighton, Massachusetts, United States, 02135
Contact: IPX159-B11-02 Study Coordinator    617-783-1441      
Beacon Clinical Research, LLC Recruiting
Brockton, Massachusetts, United States, 02301
Contact: IPX159-B11-02 Study Coordinator    508-584-2030      
United States, Michigan
QUEST Research Institute Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: IPX159-B11-02 Study Coordinator    248-957-8940      
United States, New Jersey
Global Medical Institutes, LLC Recruiting
Princeton, New Jersey, United States, 08540
Contact: IPX159-B11-02 Study Coordinator    609-921-3555      
United States, New York
Fieve Clinical Research, Inc. Recruiting
New York, New York, United States, 10168
Contact: IPX159-B11-02 Study Coordinator    212-772-3570      
Comprehensive Multiple Sclerosis Care Center Recruiting
Patchogue, New York, United States, 11772
Contact: IPX159-B11-02 Study Coordinator    631-758-1910      
United States, North Carolina
Raleigh Neurology Associates, P.A. Recruiting
Raleigh, North Carolina, United States, 27607
Contact: IPX159-B11-02 Study Cooridnator    919-420-1658      
Wake Research Associates, LLC Recruiting
Raleigh, North Carolina, United States, 27612
Contact: IPX159-B11-02 Study Coordinator    919-781-2514      
PMG Research of Wilmington, LLC Recruiting
Wilmington, North Carolina, United States, 28401
Contact: IPX159-B11-02 Study Coordinator    910-815-6108      
United States, Ohio
Community Research Recruiting
Cincinnati, Ohio, United States, 45255
Contact: IPX159-B11-02 Study Coordinator    513-281-3868      
United States, Pennsylvania
Sleep Lab of Northeastern Pennsylvania Recruiting
Clarks Summit, Pennsylvania, United States, 18411
Contact: IPX159-B11-02 Study Coordinator    570-585-6228      
United States, South Carolina
SleepMed of SC Recruiting
Columbia, South Carolina, United States, 29201
Contact: IPX159-B11-02 Study Coordinator    803-251-3093      
Coastal Carolina Research Center Recruiting
Mt. Pleasant, South Carolina, United States, 29464
Contact: IPX159-B11-02 Study Coordinator    843-856-3784      
United States, Tennessee
University of Tennesee Health Science Center Recruiting
Memphis, Tennessee, United States, 38163
Contact: IPX159-B11-02 Study Coordinator    901-448-1662      
United States, Texas
Future Research Trials of Neurology Recruiting
Austin, Texas, United States, 78731
Contact: IPX159-B11-02 Study Coordinator    512-380-9925      
Clinical Trial Network Recruiting
Houston, Texas, United States, 77074
Contact: IPX159-B11-02 Study Coordinator    713-484-6947      
Bhupesh Dihenia, M.D., P.A. Recruiting
Lubbock, Texas, United States, 79410
Contact: IPX159-B11-02 Study Coordinator    806-722-3500      
Paragon Research Center, LLC Recruiting
San Antonio, Texas, United States, 78205
Contact: IPX159-B11-02 Study Coordinator    210-340-5646      
United States, Washington
Sleep Medicine Associates Recruiting
Seattle, Washington, United States, 98122
Contact: IPX159-B11-02 Study Coordinator    206-386-4744      
Sponsors and Collaborators
IMPAX Laboratories, Inc.
Investigators
Principal Investigator: Impax Study Director Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)
  More Information

No publications provided

Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01521663     History of Changes
Other Study ID Numbers: IPX159-B11-02
Study First Received: January 23, 2012
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by IMPAX Laboratories, Inc.:
Moderate to severe idiopathic RLS

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014