NCT02633683

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: XenoPort, Inc. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• RLS

Interventions

Type	Name	Description
DRUG	HORIZANT 600 mg	HORIZANT 600 mg once daily

Timeline

• Start date: 2016-01-01
• Primary completion: 2024-05-01
• Completion: 2024-07-01
• First posted: 2015-12-17
• Last updated: 2021-06-09

Locations

11 sites across 1 country: United States