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



Status:Completed
Conditions:Restless Leg Syndrome, Neurology
Therapuetic Areas:Neurology, Rheumatology
Healthy:No
Age Range:18 - 70
Updated:2/2/2017
Start Date:November 2011
End Date:February 2013

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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.

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.

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)
We found this trial at
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
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4460 Red Bank Expressway
Cincinnati, Ohio 45227
513-721-3868
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
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8 Mirror Lake Dr # A
Ormond Beach, Florida 32174
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1148 E. Commerce St.
San Antonio, Texas 78205
(210) 340-5646
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1459 Laney-Walker Blvd
Augusta, Georgia 30901
(706) 721-3052
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Aurora, Colorado 80012
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Brighton, Massachusetts 02135
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1876 5th Avenue South
Brimingham, Alabama 35294
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Brockton, Massachusetts 02301
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Clarks Summit, Pennsylvania 18411
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Columbia, South Carolina 29201
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Crestview Hills, Kentucky 41017
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Farmington Hills, Michigan 48334
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Houston, Texas 77074
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10666 N Torrey Pines Rd
La Jolla, California 92037
(858) 554-9100
Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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Little Rock, Arkansas 72211
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Louisville, Kentucky 40217
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Princeton, New Jersey 08540
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Raleigh, North Carolina 27607
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
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Seattle, Washington 98122
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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