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Gamma-Aminobutyric Acid (GABA) Analog

HORIZANT for Restless Legs Syndrome (RLS Trial)

Phase 4
Recruiting
Research Sponsored by XenoPort, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

RLS Trial Summary

This trial is testing if a medication called HORIZANT is safe and effective for treating Restless Legs Syndrome in adolescents.

Who is the study for?
This trial is for adolescents aged 13-17 with moderate-to-severe primary Restless Legs Syndrome (RLS) who completed the HORIZANT Study XP109. Participants must not use drugs affecting RLS or sleep, and if sexually active, agree to effective contraception methods. Those with unstable medical conditions or noncompliance risks are excluded.Check my eligibility
What is being tested?
The study tests the long-term effectiveness and safety of a daily dose of HORIZANT (Gabapentin Enacarbil) at 600 mg in treating adolescent RLS. It's an extension study focusing on those who've previously taken part in related research.See study design
What are the potential side effects?
While specific side effects for this age group aren't listed here, Gabapentin Enacarbil can generally cause dizziness, sleepiness, headache, nausea, and fatigue among others.

RLS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Global Impression of Improvement (CGI-I) score

Side effects data

From 2021 Phase 4 trial • 88 Patients • NCT03012815
2%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin
Benzodiazepine

RLS Trial Design

1Treatment groups
Experimental Treatment
Group I: HORIZANT 600 mgExperimental Treatment1 Intervention
HORIZANT 600 mg once daily

Find a Location

Who is running the clinical trial?

XenoPort, Inc.Lead Sponsor
27 Previous Clinical Trials
5,423 Total Patients Enrolled
Steven Caras, MDStudy DirectorXenoport/Arbor Pharmaceuticals, LLC
2 Previous Clinical Trials
132 Total Patients Enrolled

Media Library

HORIZANT (Gamma-Aminobutyric Acid (GABA) Analog) Clinical Trial Eligibility Overview. Trial Name: NCT02633683 — Phase 4
Restless Leg Syndrome Research Study Groups: HORIZANT 600 mg
Restless Leg Syndrome Clinical Trial 2023: HORIZANT Highlights & Side Effects. Trial Name: NCT02633683 — Phase 4
HORIZANT (Gamma-Aminobutyric Acid (GABA) Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02633683 — Phase 4
Restless Leg Syndrome Patient Testimony for trial: Trial Name: NCT02633683 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What adverse effects could arise from ingesting HORIZANT 600 mg?

"With the drug having already been authorised for use, HORIZANT 600 mg's safety level is graded as a 3 on our scale. This evaluation comes from its being in Phase 4 of clinical trials."

Answered by AI

Is this medical trial unprecedented in its scope and methodology?

"Since 2016, HORIZANT 600 mg has been a subject of medical research. The initial trial in that year was sponsored by XenoPort Inc., and the subsequent Phase 4 drug approval occurred after 144 patients participated successfully. In total, there are presently 3 ongoing studies related to this medication across 14 urban centres within one nation."

Answered by AI

How many medical facilities in this state are administering the trial?

"Presently, potential participants can choose to enroll at 4 different medical sites - Indianapolis, San Diego and Winter Park being the most prominent. It is recommended that patients pick the location closest to them in order to reduce any travel-related stressors."

Answered by AI

How many volunteers have registered for this experiment?

"Affirmative. Per the information procured from clinicaltrials.gov, this medical trial is currently taking applications. It was initially posted on January 1st 2016 and recently modified on June 7th 2021; for it to be successful 144 participants must be accepted across 4 different sites."

Answered by AI

To what extent must an individual meet certain criteria to partake in this trial?

"This medical trial is seeking 144 individuals aged 13 to 17 who have restless leg syndrome and are willing to abstain from any substances that could impact the result of their assessment. Additionally, before partaking in study procedures, both patient and guardian must sign IRB-approved assent and consent forms."

Answered by AI

Are there any vacancies in this medical trial for prospective participants?

"Yes, the data available on clinicaltrials.gov confirms that this study is presently accepting participants. It was first made public on January 1st 2016 with a most recent update occurring on June 7th 2021. The trial aims to enrol 144 patients from 4 separate sites."

Answered by AI

Is enrollment open to participants older than 45 years of age?

"The parameters for patient eligibility are between 13 and 17 years old, in compliance with the study's stated inclusion criteria."

Answered by AI

Has the efficacy of HORIZANT 600 mg been explored in other studies?

"The first HORIZANT 600 mg study was conducted in 2016 by the Stanford Sleep Medicine Centre. Since then, 26 trials have completed and 3 are ongoing - all of which utilise Indianapolis, Indiana as their primary location."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
Florida
California
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Pacific Research Network
Florida Pediatric Research Institute
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm tired of the pain in my legs and the uncomfortable feeling that it gives me and more than anything I totally hate pain.
PatientReceived 1 prior treatment
~1 spots leftby May 2024