An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS
Public ClinicalTrials.gov record NCT02633683. 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.
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 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02633683
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 144 participants
Conditions and interventions
Conditions
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
- Dec 31, 2015
- Primary completion
- Apr 30, 2024
- Completion
- Jun 30, 2024
- Last update posted
- Jun 8, 2021
2016 – 2024
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford Sleep Medicine Center | Redwood City | California | 94063 | Withdrawn |
| Pacific Research Network | San Diego | California | 92103 | Recruiting |
| NW FL Clinical Research Group | Gulf Breeze | Florida | 32561 | Withdrawn |
| Florida Pediatric Research Institute | Winter Park | Florida | 32789 | Recruiting |
| Clinical Integrative Research Center of Atlanta, INC | Atlanta | Georgia | 30328 | Withdrawn |
| Josephson Wallack Munshower Neurology, PC | Indianapolis | Indiana | 46256 | 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| Dent Neurologic Institute | Amherst | New York | 14226 | Withdrawn |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 |
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 NCT02633683, 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 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02633683 live on ClinicalTrials.gov.