Recruiting

HORIZANT

Sponsor:

XenoPort, Inc.

Code:

NCT02633683

Conditions

RLS

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

HORIZANT 600 mg

Study Details

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

Study ID

NCT02633683

Start date

Jan, 2016

Status verified date

Jun, 2021

Completion date

Jul, 2024

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

144 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HORIZANT 600 mg

HORIZANT 600 mg once daily

Interventions

HORIZANT 600 mg

HORIZANT 600 mg once daily

Primary outcome measure

  • Clinical Global Impression of Improvement (CGI-I) score [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Camilla Alexander

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

Locations

Pacific Research Network

Recruiting

San Diego, California, United States, 92103

Contacts

Dixie Creager

619-294-4302dcreager@prnsd.com

Jamie Jjirk

619-294-4302jjirik@prnsd.com

Principal Investigator:

Stephen Thein, PhD

Florida Pediatric Research Institute

Recruiting

Winter Park, Florida, United States, 32789

Contacts

Heidi Patenaude

407-898-2767heidi@ajayihealthcare.com

Sarah Simonian

407-898-2767sarah@ajayihealthcare.com

Principal Investigator:

Akinyemi Ajayi, MD

Josephson Wallack Munshower Neurology, PC

Recruiting

Indianapolis, Indiana, United States, 46256

Contacts

Kristi Mann

317-537-6088kcleveland@jwmneuro.com

Kristina Cleveland

317-806-6965kcleveland@jwmneuro.com

Principal Investigator:

Ridel, MD

SleepMed of South Carolina; SleepMed, Inc.

Recruiting

Columbia, South Carolina, United States, 29201

Contacts

Natalie Scallon, CRC

803-251-1093nscallon@sleepmedinc.com

Principal Investigator:

Richard Bogan, MD

More Information

Sponsor

XenoPort, Inc.

Last update posted

Jun 9, 2021

Last verified

Jun, 2021

Keywords

  • Restless Legs Syndrome
  • RLS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by XenoPort, Inc. on 2021-06-09.