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

RLS Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02633683
• Other study ID #: XP110
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: July 2024

Study information

• Verified date: June 2021
• Source: XenoPort, Inc.
• Contact: Camilla Alexander
• Phone: 520-252-1908
• Email: Camilla.Alexander[@]wwctrials.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: July 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Restless Legs Syndrome
• RLS

Intervention

Drug:
• HORIZANT 600 mg
HORIZANT 600 mg once daily

Locations

Country	Name	City	State
United States	Dent Neurologic Institute	Amherst	New York
United States	Clinical Integrative Research Center of Atlanta, INC	Atlanta	Georgia
United States	SleepMed of South Carolina; SleepMed, Inc.	Columbia	South Carolina
United States	NW FL Clinical Research Group	Gulf Breeze	Florida
United States	Josephson Wallack Munshower Neurology, PC	Indianapolis	Indiana
United States	Vanderbilt University School of Medicine	Nashville	Tennessee
United States	The Sleep Center at the Childrens Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Stanford Sleep Medicine Center	Redwood City	California
United States	Pacific Research Network	San Diego	California
United States	Mercy Health - Children's Hospital Pulmonary & Sleep Center	Toledo	Ohio
United States	Florida Pediatric Research Institute	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
XenoPort, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression of Improvement (CGI-I) score	assessment at designated timepoints	Week 12