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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT01521663
First received: January 23, 2012
Last updated: January 31, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Restless Legs Syndrome Drug: IPX159 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

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 ]

Enrollment: 159
Study Start Date: November 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 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)
  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

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: January 31, 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:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2017