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

NCT02633683 | Unknown Phase 4

• 1 other identifier: XP110
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

RLS

Keywords

Restless Legs Syndrome; RLS

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression of Improvement (CGI-I) score

  assessment at designated timepoints

  Week 12

Study Arms (1)

HORIZANT 600 mg

EXPERIMENTAL

HORIZANT 600 mg once daily

Drug: HORIZANT 600 mg

Interventions

HORIZANT 600 mg DRUG

HORIZANT 600 mg once daily

Also known as: Gabapentin Enacarbil Extended-Release Tablets

HORIZANT 600 mg

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• XenoPort, Inc.: lead

Study Sites (11)

Stanford Sleep Medicine Center

Redwood City, California, 94063, United States

WITHDRAWN

Pacific Research Network

San Diego, California, 92103, United States

RECRUITING

NW FL Clinical Research Group

Gulf Breeze, Florida, 32561, United States

WITHDRAWN

Florida Pediatric Research Institute

Winter Park, Florida, 32789, United States

RECRUITING

Clinical Integrative Research Center of Atlanta, INC

Atlanta, Georgia, 30328, United States

WITHDRAWN

Josephson Wallack Munshower Neurology, PC

Indianapolis, Indiana, 46256, United States

RECRUITING

Dent Neurologic Institute

Amherst, New York, 14226, United States

WITHDRAWN

Mercy Health - Children's Hospital Pulmonary & Sleep Center

Toledo, Ohio, 43608, United States

TERMINATED

The Sleep Center at the Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

WITHDRAWN

SleepMed of South Carolina; SleepMed, Inc.

Columbia, South Carolina, 29201, United States

RECRUITING

Vanderbilt University School of Medicine

Nashville, Tennessee, 37232, United States

WITHDRAWN

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Steven Caras, MD

  Xenoport/Arbor Pharmaceuticals, LLC

  STUDY DIRECTOR

Central Study Contacts

Camilla Alexander

CONTACT

520-252-1908; Camilla.Alexander@wwctrials.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 17, 2015
• Study Start: January 1, 2016
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)