Clinical trial NCT01521663: Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Restless Legs Syndrome
Keywords: Moderate to severe idiopathic RLS
Lead sponsor: Impax Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2012-01-31
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale
timeFrame: Assessed at each study visit (visits 1-7), an expected average of 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brimingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc.
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Oceanside
country: United States
facility: The Research Center of Southern California
state: California
city: Redwood City
country: United States
facility: Stanford Center for Human Sleep Research
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Aurora
country: United States
facility: Sleep-Alertness Disorder Center
state: Colorado
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Palm Harbor
country: United States
facility: Resurgence Group
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research Inc
state: Georgia
city: Augusta
country: United States
facility: Georgia Health Sciences University
state: Georgia
city: Macon
country: United States
facility: SleepMed of Central Georgia
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Crestview Hills
country: United States
facility: Community Research
state: Kentucky
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center Campus
state: Maryland
city: Brighton
country: United States
facility: Sleep Health Centers, LLC
state: Massachusetts
city: Brockton
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Farmington Hills
country: United States
facility: QUEST Research Institute
state: Michigan
city: Princeton
country: United States
facility: Global Medical Institutes, LLC
state: New Jersey
city: New York
country: United States
facility: Fieve Clinical Research, Inc.
state: New York
city: Patchogue
country: United States
facility: Comprehensive Multiple Sclerosis Care Center
state: New York
city: Raleigh
country: United States
facility: Raleigh Neurology Associates, P.A.
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Clarks Summit
country: United States
facility: Sleep Lab of Northeastern Pennsylvania
state: Pennsylvania
city: Columbia
country: United States
facility: SleepMed of SC
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Memphis
country: United States
facility: University of Tennesee Health Science Center
state: Tennessee
city: Austin
country: United States
facility: Future Research Trials of Neurology
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Lubbock
country: United States
facility: Bhupesh Dihenia, M.D., P.A.
state: Texas
city: San Antonio
country: United States
facility: Paragon Research Center, LLC
state: Texas
city: Seattle
country: United States
facility: Sleep Medicine Associates
state: Washington
Study officials:
affiliation: Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)
name: Impax Study Director
role: PRINCIPAL_INVESTIGATOR
References: