NCT02560766

An Efficacy and Safety Evaluation of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS

A Multicenter, Double-Blind, Placebo Controlled, Parallel Group, Efficacy and Safety Evaluation of HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) in Adolescents Aged 13 to 17 Years Old With Moderate-to-Severe Primary RLS

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: XenoPort, Inc. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the trial is to evaluate the efficacy of HORIZANT 300 mg and 600 mg, compared to placebo, at 12 weeks of treatment, for the treatment of Restless Legs Syndrome (RLS) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS.

Detailed description

This is a multicenter, double-blind, placebo-controlled, 3 arm, parallel group study of HORIZANT in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS. Eligible patients enter a 7-day screening period during which safety assessments are performed. Eligible patients are randomized in a 1:1:1 ratio to HORIZANT 300 mg or 600 mg, or matching placebo, followed by a 12-week treatment period. Patients take the study drug once daily at approximately 5 PM with food. Patients will visit the clinical site on 5 or 6 different occasions.

Conditions

• RLS

Interventions

Type	Name	Description
DRUG	HORIZANT 300 mg	HORIZANT 300 mg once daily
DRUG	HORIZANT 600 mg	HORIZANT 600 mg once daily
DRUG	Placebo	Placebo once daily

Timeline

• Start date: 2016-02-01
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2015-09-25
• Last updated: 2021-06-09

Locations

12 sites across 1 country: United States