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

This study has been completed.
Information provided by (Responsible Party):
IMPAX Laboratories, Inc. Identifier:
First received: January 23, 2012
Last updated: September 8, 2015
Last verified: September 2015

January 23, 2012
September 8, 2015
November 2011
February 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01521663 on Archive Site
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Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)
A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of IPX159 in the Treatment of Moderate to Severe Restless Legs Syndrome (RLS)
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.
Not Provided
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Restless Legs Syndrome
  • Drug: IPX159
  • Drug: Placebo
  • 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.
    Intervention: 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2013
February 2013   (final data collection date for primary outcome measure)

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 Contract Research Organization (if any)
18 Years to 70 Years
Contact information is only displayed when the study is recruiting subjects
United States
IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc.
Not Provided
Principal Investigator: Impax Study Director Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)
IMPAX Laboratories, Inc.
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP