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

ClinicalTrials.gov ID: NCT02560766

Public ClinicalTrials.gov record NCT02560766. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 4, 2026, 8:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT02560766
Recruitment status: Not listed
Study type: Interventional
Phase: Phase 4
Lead sponsor: XenoPort, Inc.; Industry
Enrollment: 132 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 13 Years to 17 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 31, 2016
Primary completion: Sep 30, 2023
Completion: Sep 30, 2023
Last update posted: Jun 8, 2021

2016 – 2023

United States locations

U.S. sites: 12
U.S. states: 11
U.S. cities: 12

Facility	City	State	ZIP	Site status
Stanford Sleep Medicine Center	Redwood City	California	94063	Withdrawn
NW FL Clinical Research Group	Gulf Breeze	Florida	32561	Terminated
Orlando Pediatric Pulmonary and Sleep	Winter Park	Florida	32789	Recruiting
PANDA Neurology/CIRCA	Atlanta	Georgia	30328	Withdrawn
Josephson Wallack Munshower Neurology, PC	Indianapolis	Indiana	46256	Withdrawn
Pacific Research Network	St Louis	Missouri	63179	Recruiting
Dent Neurologic Institute	Amherst	New York	14226	Withdrawn
Mercy Health - Children's Hospital Pulmonary & Sleep Center	Toledo	Ohio	43608	Terminated
The Sleep Center at the Childrens Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Withdrawn
SleepMed of South Carolina; SleepMed, Inc.	Columbia	South Carolina	29201	Recruiting
Vanderbilt University School of Medicine	Nashville	Tennessee	37232	Withdrawn
Road Runner Research	San Antonio	Texas	78249	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02560766, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 8, 2021 · Synced Sep 4, 2026

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The complete protocol, eligibility criteria, and contact information for NCT02560766 live on ClinicalTrials.gov.

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