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

Status unconfirmed · Phase 4

Conditions studied: RLS

In brief

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.

Key facts

Study ID

NCT02633683

Run by

XenoPort, Inc.

People needed

144

Starts

2016-01-01

Expected to finish

2024-07-01

Last updated by the study team

2021-06-09

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who completed participation in HORIZANT Study XP109.
• Negative pregnancy test for females of childbearing potential. Male patients able to father a child must agree to use a barrier method (male condom, female condom, diaphragm, or cervical cap) with spermicide for at least 30 days prior to dosing and throughout the study. Fertile, sexually active patients must agree to use 2 medically accepted methods of contraception
• Patients must be willing to refrain from using any drugs that are likely to affect RLS or sleep assessments for the duration of the study.
• Signed patient and parent (or legal guardian) Institutional Review Board (IRB)-approved assent and consent forms before any study procedures are carried out

You may not qualify if…

• Patients who, in the opinion of the investigator, would be noncompliant with the study visit schedule, procedures, or medication administration
• Patients who have developed clinically significant or unstable medical conditions, or who would otherwise be unsuitable for participation in a continuation study with gabapentin enacarbil

Where it is running

• Pacific Research Network — San Diego, California, United States (enrolling)
• Josephson Wallack Munshower Neurology, PC — Indianapolis, Indiana, United States (enrolling)
• SleepMed of South Carolina; SleepMed, Inc. — Columbia, South Carolina, United States (enrolling)
• Florida Pediatric Research Institute — Winter Park, Florida, United States (enrolling)
• Mercy Health - Children's Hospital Pulmonary & Sleep Center — Toledo, Ohio, United States
• The Sleep Center at the Childrens Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Stanford Sleep Medicine Center — Redwood City, California, United States
• Vanderbilt University School of Medicine — Nashville, Tennessee, United States
• NW FL Clinical Research Group — Gulf Breeze, Florida, United States
• Clinical Integrative Research Center of Atlanta, INC — Atlanta, Georgia, United States
• Dent Neurologic Institute — Amherst, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.