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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01521663
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.

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.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: IPX159 Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : November 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Drug: IPX159
Placebo Comparator: Sugar Pill
IPX159 90 mg matching placebo daily at week 1 with titration to 180 mg matching placebo daily at week 2.
Drug: Placebo

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01521663

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham
Brimingham, Alabama, United States, 35294
United States, Arkansas
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States, 72211
United States, California
Scripps Clinic
La Jolla, California, United States, 92037
Collaborative Neuroscience Network, Inc.
Long Beach, California, United States, 90806
The Research Center of Southern California
Oceanside, California, United States, 92056
Stanford Center for Human Sleep Research
Redwood City, California, United States, 94063
Neurological Research Institute
Santa Monica, California, United States, 90404
United States, Colorado
Sleep-Alertness Disorder Center
Aurora, Colorado, United States, 80012
United States, Florida
PAB Clinical Research
Brandon, Florida, United States, 33511
MD Clinical
Hallandale Beach, Florida, United States, 33009
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States, 32174
Resurgence Group
Palm Harbor, Florida, United States, 34684
United States, Georgia
NeuroTrials Research Inc
Atlanta, Georgia, United States, 30342
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
SleepMed of Central Georgia
Macon, Georgia, United States, 31201
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Community Research
Crestview Hills, Kentucky, United States, 41017
Kentucky Research Group
Louisville, Kentucky, United States, 40217
United States, Maryland
Johns Hopkins Bayview Medical Center Campus
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Sleep Health Centers, LLC
Brighton, Massachusetts, United States, 02135
Beacon Clinical Research, LLC
Brockton, Massachusetts, United States, 02301
United States, Michigan
QUEST Research Institute
Farmington Hills, Michigan, United States, 48334
United States, New Jersey
Global Medical Institutes, LLC
Princeton, New Jersey, United States, 08540
United States, New York
Fieve Clinical Research, Inc.
New York, New York, United States, 10168
Comprehensive Multiple Sclerosis Care Center
Patchogue, New York, United States, 11772
United States, North Carolina
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, United States, 27607
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States, 28401
United States, Ohio
Community Research
Cincinnati, Ohio, United States, 45255
United States, Pennsylvania
Sleep Lab of Northeastern Pennsylvania
Clarks Summit, Pennsylvania, United States, 18411
United States, South Carolina
SleepMed of SC
Columbia, South Carolina, United States, 29201
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
University of Tennesee Health Science Center
Memphis, Tennessee, United States, 38163
United States, Texas
Future Research Trials of Neurology
Austin, Texas, United States, 78731
Clinical Trial Network
Houston, Texas, United States, 77074
Bhupesh Dihenia, M.D., P.A.
Lubbock, Texas, United States, 79410
Paragon Research Center, LLC
San Antonio, Texas, United States, 78205
United States, Washington
Sleep Medicine Associates
Seattle, Washington, United States, 98122
Sponsors and Collaborators
IMPAX Laboratories, Inc.
Principal Investigator: Impax Study Director Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)

Responsible Party: IMPAX Laboratories, Inc. Identifier: NCT01521663     History of Changes
Other Study ID Numbers: IPX159-B11-02
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

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