Trial record 6 of 28 for:    Open Studies | "Restless Legs Syndrome"

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

  Show 38 Study Locations
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 28, 2014