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

June 7, 2021 updated by: XenoPort, Inc.

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients who complete the 12-week daily dosing efficacy and safety study (XP109) will be allowed to enroll in the open-label extension (OLE) study (XP110), thereby providing exposure to HORIZANT for up to 48 weeks. Enrolled patients will take open-label HORIZANT 600 mg tablets once a day at approximately 5 PM with food, beginning at Week 0 of the OLE study up to and including Week 36. After the end of the treatment period, a follow-up visit will be included 14 days (± 3 days) after the last dose of HORIZANT. Patients will visit the clinical site on 6 different occasions, including a follow-up visit 14 days (± 3 days) after the last dose of study drug.

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94063
        • Withdrawn
        • Stanford Sleep Medicine Center
      • San Diego, California, United States, 92103
        • Recruiting
        • Pacific Research Network
        • Contact:
        • Contact:
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Withdrawn
        • NW FL Clinical Research Group
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Withdrawn
        • Clinical Integrative Research Center of Atlanta, Inc
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Josephson Wallack Munshower Neurology, PC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ridel, MD
    • New York
      • Amherst, New York, United States, 14226
        • Withdrawn
        • Dent Neurologic Institute
    • Ohio
      • Toledo, Ohio, United States, 43608
        • Terminated
        • Mercy Health - Children's Hospital Pulmonary & Sleep Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Withdrawn
        • The Sleep Center at the Childrens Hospital of Philadelphia
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Recruiting
        • SleepMed of South Carolina; SleepMed, Inc.
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Withdrawn
        • Vanderbilt University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HORIZANT 600 mg
HORIZANT 600 mg once daily
Drug: HORIZANT 600 mg
HORIZANT 600 mg once daily
Other Names:
  • Gabapentin Enacarbil Extended-Release Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression of Improvement (CGI-I) score
Time Frame: Week 12
assessment at designated timepoints
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XenoPort, Inc.

Investigators

  • Study Director: Steven Caras, MD, Xenoport/Arbor Pharmaceuticals, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 14, 2015

First Posted (Estimate)

December 17, 2015

Study Record Updates

Last Update Posted (Actual)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XP110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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