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.

Study Overview

• Status: Completed
• Conditions: Restless Legs Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: IPX159

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
• Enrollment (Actual): 159
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale	Assessed at each study visit (visits 1-7), an expected average of 11 weeks

Collaborators and Investigators

• Sponsor: Impax Laboratories, LLC
• Investigators: Principal Investigator: Impax Study Director, Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: January 23, 2012
• First Submitted That Met QC Criteria: January 26, 2012
• First Posted (Estimate): January 31, 2012

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Moderate to severe idiopathic RLS
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Syndrome; Psychomotor Agitation; Restless Legs Syndrome
• Other Study ID Numbers: IPX159-B11-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No