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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

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The mean change from baseline to week 4 in intensity of cortical arousals associated with periodic limb movements (PLMs)

Secondary study objectives

The mean change from Baseline to week 4 in Rechtschaffen and Kales polysomnography parameters

The mean change from baseline to week 4 in blood pressure associated with arousals secondary to periodic limb movements (PLMs)

The mean change from baseline to week 4 in heart rate variability associated with arousals secondary to periodic limb movements (PLMs)

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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