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

Restless Legs Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521663
• Other study ID #: IPX159-B11-02
• Status: Completed
• Phase: Phase 2
• First received: January 23, 2012
• Last updated: January 31, 2017
• Start date: November 2011
• Est. completion date: February 2013

Study information

• Verified date: January 2017
• Source: IMPAX Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• IPX159

• Placebo

Locations

Country	Name	City	State
United States	NeuroTrials Research Inc	Atlanta	Georgia
United States	Georgia Health Sciences University	Augusta	Georgia
United States	Sleep-Alertness Disorder Center	Aurora	Colorado
United States	Future Research Trials of Neurology	Austin	Texas
United States	Johns Hopkins Bayview Medical Center Campus	Baltimore	Maryland
United States	PAB Clinical Research	Brandon	Florida
United States	Sleep Health Centers, LLC	Brighton	Massachusetts
United States	University of Alabama at Birmingham	Brimingham	Alabama
United States	Beacon Clinical Research, LLC	Brockton	Massachusetts
United States	Community Research	Cincinnati	Ohio
United States	Sleep Lab of Northeastern Pennsylvania	Clarks Summit	Pennsylvania
United States	SleepMed of SC	Columbia	South Carolina
United States	Community Research	Crestview Hills	Kentucky
United States	QUEST Research Institute	Farmington Hills	Michigan
United States	MD Clinical	Hallandale Beach	Florida
United States	Clinical Trial Network	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Scripps Clinic	La Jolla	California
United States	Preferred Research Partners, Inc.	Little Rock	Arkansas
United States	Collaborative Neuroscience Network, Inc.	Long Beach	California
United States	Kentucky Research Group	Louisville	Kentucky
United States	Bhupesh Dihenia, M.D., P.A.	Lubbock	Texas
United States	SleepMed of Central Georgia	Macon	Georgia
United States	University of Tennesee Health Science Center	Memphis	Tennessee
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Fieve Clinical Research, Inc.	New York	New York
United States	The Research Center of Southern California	Oceanside	California
United States	Neurology Associates of Ormond Beach	Ormond Beach	Florida
United States	Resurgence Group	Palm Harbor	Florida
United States	Comprehensive Multiple Sclerosis Care Center	Patchogue	New York
United States	Global Medical Institutes, LLC	Princeton	New Jersey
United States	Raleigh Neurology Associates, P.A.	Raleigh	North Carolina
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Stanford Center for Human Sleep Research	Redwood City	California
United States	Paragon Research Center, LLC	San Antonio	Texas
United States	Neurological Research Institute	Santa Monica	California
United States	Sleep Medicine Associates	Seattle	Washington
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
IMPAX Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale		Assessed at each study visit (visits 1-7), an expected average of 11 weeks