NCT02633657

A PK and Safety Evaluation of HORIZANT (Gabapentin Enacarbil) in Adolescents With Moderate-to-Severe Primary RLS

A Multicenter, Open-label, Single-dose Pharmacokinetic and Safety Evaluation of HORIZANT (Gabapentin Enacarbil Extended-release Tablets) in Adolescents Aged 13 to 17 Years Old With Moderate-to-severe Primary Restless Legs Syndrome

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: XenoPort, Inc. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to assess the pharmacokinetics (PK) of gabapentin following the single-dose administration of HORIZANT (Gabapentin Enacarbil) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe Primary Restless Legs Syndrome (RLS).

Detailed description

One-treatment, 1-period study in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS. Patients will check-in at the clinical site in the evening of Day -1 or the morning of Day 0, and baseline safety assessments will be performed. On Day 0, after the review of these safety assessments and confirmation of eligibility, patients will receive a single oral 300 mg dose of HORIZANT with a meal (at approximately 6 AM). Study assessments will continue until approximately 14 hours (h) post dose, at which time patients will be discharged. Prior to discharge, patients will be advised not to drive a car or operate other complex machinery for at least 30 h after dosing; therefore, patients can remain at the clinical site overnight or can be escorted home. Patients will return to the clinical site for a follow-up visit 7 days (± 1 day) post dose.

Conditions

• RLS

Interventions

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

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-07-19
• Completion: 2017-07-19
• First posted: 2015-12-17
• Last updated: 2021-04-12

Locations

4 sites across 1 country: United States