HORIZANT 600 mg for Restless Legs Syndrome

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Restless Legs Syndrome+1 More
HORIZANT 600 mg - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Restless Legs Syndrome
  • RLS

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Restless Legs Syndrome

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Week 12

Week 12
Clinical Global Impression of Improvement (CGI-I) score

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Restless Legs Syndrome

Side Effects for

Gabapentin
2%Allergic reaction
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT03012815) in the Gabapentin ARM group. Side effects include: Allergic reaction with 2%.

Trial Design

1 Treatment Group

HORIZANT 600 mg
1 of 1
Experimental Treatment

144 Total Participants · 1 Treatment Group

Primary Treatment: HORIZANT 600 mg · No Placebo Group · Phase 4

HORIZANT 600 mg
Drug
Experimental Group · 1 Intervention: HORIZANT 600 mg · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 12

Who is running the clinical trial?

XenoPort, Inc.Lead Sponsor
27 Previous Clinical Trials
5,423 Total Patients Enrolled
13 Trials studying Restless Legs Syndrome
2,565 Patients Enrolled for Restless Legs Syndrome
Steven Caras, MDStudy DirectorXenoport/Arbor Pharmaceuticals, LLC
2 Previous Clinical Trials
132 Total Patients Enrolled
1 Trials studying Restless Legs Syndrome

Eligibility Criteria

Age < 18 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to refrain from using any drugs that are likely to affect RLS or sleep assessments for the duration of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: October 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Louisiana100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%