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Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome

NCT02424695 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-04-23

No results posted yet for this 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.

Conditions

  • Restless Legs Syndrome

Interventions

DRUG

Gabapentin Enacarbil (GEn)

HORIZANT Extended-Release Tablets containing 600 mg of gabapentin enacarbil are white to off-white, with occasional black/grey spots, oval-shaped tablets debossed with "GS LFG", supplied as: 600 mg: NDC 53451-0101-1.The drug will be stored at 25°C (77°F) (excursions permitted 15° to 30°C (59° to 86°F)) Matching placebo will be provided by Xenoport Inc.

DRUG

Placebo

Sponsors & Collaborators

  • Cleveland Sleep Research Center

    lead OTHER

  • XenoPort, Inc.

    collaborator INDUSTRY

  • YRT Limited

    collaborator UNKNOWN

Principal Investigators

  • Mansoor Ahmed, MD · Cleveland Sleep Research Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-06-30
Completion
2016-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02424695 on ClinicalTrials.gov