Clinical trial NCT02633683: An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: RLS
Keywords: Restless Legs Syndrome
RLS
Lead sponsor: XenoPort, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-17
Enrollment: 144
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Global Impression of Improvement (CGI-I) score
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Sleep Medicine Center
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: Gulf Breeze
country: United States
facility: NW FL Clinical Research Group
state: Florida
city: Winter Park
country: United States
facility: Florida Pediatric Research Institute
state: Florida
city: Atlanta
country: United States
facility: Clinical Integrative Research Center of Atlanta, INC
state: Georgia
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology, PC
state: Indiana
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Toledo
country: United States
facility: Mercy Health - Children's Hospital Pulmonary & Sleep Center
state: Ohio
city: Philadelphia
country: United States
facility: The Sleep Center at the Childrens Hospital of Philadelphia
state: Pennsylvania
city: Columbia
country: United States
facility: SleepMed of South Carolina; SleepMed, Inc.
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University School of Medicine
state: Tennessee
Study officials:
affiliation: Xenoport/Arbor Pharmaceuticals, LLC
name: Steven Caras, MD
role: STUDY_DIRECTOR
References: