An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS



Status:Recruiting
Healthy:No
Age Range:13 - 17
Updated:3/2/2019
Start Date:January 2016
End Date:July 2024
Contact:Camilla Alexander
Email:Camilla.Alexander@wwctrials.com
Phone:520-252-1908

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A Multicenter Open-Label Extension Study to Evaluate the Efficacy and Safety of HORIZANT (Gabapentin Enacarbil) Extended-Release Tablets in Adolescents Aged 13 to 17 Years Old With Moderate-to-Severe Primary Restless Legs Syndrome

The objectives of the trial are to evaluate the long-term efficacy and safety of HORIZANT
(Gabapentin Enacarbil) 600 mg daily, for the treatment of RLS in adolescents (13 to 17 years
of age) diagnosed with moderate-to-severe primary RLS.

Patients who complete the 12-week daily dosing efficacy and safety study (XP109) will be
allowed to enroll in the open-label extension (OLE) study (XP110), thereby providing exposure
to HORIZANT for up to 48 weeks. Enrolled patients will take open-label HORIZANT 600 mg
tablets once a day at approximately 5 PM with food, beginning at Week 0 of the OLE study up
to and including Week 36. After the end of the treatment period, a follow-up visit will be
included 14 days (± 3 days) after the last dose of HORIZANT. Patients will visit the clinical
site on 6 different occasions, including a follow-up visit 14 days (± 3 days) after the last
dose of study drug.

Inclusion Criteria:

Patients who completed participation in HORIZANT Study XP109.

- Negative pregnancy test for females of childbearing potential. Male patients able to
father a child must agree to use a barrier method (male condom, female condom,
diaphragm, or cervical cap) with spermicide for at least 30 days prior to dosing and
throughout the study. Fertile, sexually active patients must agree to use 2 medically
accepted methods of contraception

- Patients must be willing to refrain from using any drugs that are likely to affect RLS
or sleep assessments for the duration of the study.

- Signed patient and parent (or legal guardian) Institutional Review Board
(IRB)-approved assent and consent forms before any study procedures are carried out

Exclusion Criteria:

- Patients who, in the opinion of the investigator, would be noncompliant with the study
visit schedule, procedures, or medication administration

- Patients who have developed clinically significant or unstable medical conditions, or
who would otherwise be unsuitable for participation in a continuation study with
gabapentin enacarbil
We found this trial at
11
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Indianapolis, Indiana 46256
Phone: 317-537-6088
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Amherst, New York 14226
Principal Investigator: Kenneth Murray, MD
Phone: 716-558-3492
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5673 Ptree Dun Rd NE # 440
Atlanta, Georgia 30342
Principal Investigator: Robert Flamini, MD
Phone: 678-705-7341
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700 Gervais Street
Columbia, South Carolina 29201
Principal Investigator: Richard Bogan, MD
Phone: 803-251-1093
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Gulf Breeze, Florida 32561
Principal Investigator: Gulner Com, MD
Phone: 307-459-0135
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Nashville, Tennessee 37232
Principal Investigator: Arthur Walters, MD
Phone: 615-936-8102
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3401 Civic Center Boulevard
Philadelphia, Pennsylvania 19104
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Redwood City, California 94063
Principal Investigator: Clete Kushida, MD
Phone: 650-721-7576
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San Diego, California 92103
Principal Investigator: Stephen Thein, MD
Phone: 619-294-4302
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Toledo, Ohio 43608
Principal Investigator: Reddy Ramaliga, MD
Phone: 419-251-4919
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Toledo, OH
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Winter Park, Florida 32789
Principal Investigator: Akinyemi Ajayi, MD
Phone: 407-898-2767
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Winter Park, FL
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