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Single Gabapentin Enacarbil Arm for Restless Legs Syndrome

Phase 4
Waitlist Available
Led By Mansoor Ahmed, MD
Research Sponsored by Cleveland Sleep Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This is a phase IV single-blind, placebo run-in fixed dose single-group study to assess objective and subjective effects of GEn on sleep EEG, BP, and anterior tibialis EMG responsivity in patients with RLS. The study will include 8 visits over a period of up to 8 weeks for eligible subjects including a 1 to 3-week Screening/Washout Period, a 1-week placebo run-in period, and a 4-week Treatment Period.The first placebo dose will be administered within 1 to 3 weeks after Screening/Washout. The total duration of the study from the first subject enrolled to the last subject completed will be approximately 1 year.

Eligible Conditions
  • Restless Legs Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The mean change from baseline to week 4 in intensity of cortical arousals associated with periodic limb movements (PLMs)
Secondary outcome measures
Number of subjects with mild, moderate and severe adverse events
Number of subjects with treatment emergent adverse events
The mean change from Baseline to week 4 in Post Sleep Questionnaire (PSQ)scores
+11 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Gabapentin Enacarbil ArmExperimental Treatment2 Interventions
Gabapentin Enacarbil (Gen) 600 mg will be administered once daily for 4 weeks Matching placebo will be administered once daily for one week prior initiation of treatment with GEn
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Cleveland Sleep Research CenterLead Sponsor
YRT LimitedUNKNOWN
XenoPort, Inc.Industry Sponsor
27 Previous Clinical Trials
5,547 Total Patients Enrolled
13 Trials studying Restless Legs Syndrome
2,689 Patients Enrolled for Restless Legs Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome
Mansoor Ahmed M.D. 2015. "Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02424695.
All > Blood Pressure > Gabapentin
~2 spots leftby Apr 2025
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