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Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in 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 Leg Syndrome
- Restless Legs Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
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 moreAwards & 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
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