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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR HORIZANT

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Clinical Trials for Horizant

Trial ID Title Status Sponsor Phase Summary
NCT01668667 Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome Post Marketing Commitment Study Completed XenoPort, Inc. Phase 4 Gabapentin enacarbil (GEn; GSK1838262; HORIZANT), at a dose of 600 mg/day, is currently approved in the United States for the treatment of adults with moderate-to-severe primary Restless Legs Syndrome (RLS). The aim of this study is to compare the efficacy, tolerability, and safety of GEn at lower doses (450 and 300 mg/day) as well as the already approved dose of 600 mg/day versus placebo for the treatment of subjects with moderate to severe primary RLS. This study is being conducted as a post-marketing commitment (PMC) as a condition of the approval of HORIZANT tablets (NDA 022399).
NCT02117076 Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome Terminated Theresa Zesiewicz Phase 4 The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin) versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome.
NCT02252536 HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder Active, not recruiting XenoPort, Inc. Phase 2 The purpose of this study is to determine whether gabapentin enacarbil is effective in the treatment of problems with alcohol.
NCT02252536 HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder Active, not recruiting National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 The purpose of this study is to determine whether gabapentin enacarbil is effective in the treatment of problems with alcohol.
NCT02424695 Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome Not yet recruiting XenoPort, Inc. Phase 4 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.
NCT02424695 Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome Not yet recruiting YRT Limited Phase 4 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Horizant

Condition Name

Condition Name for Horizant
Intervention Trials
RLS 3
Restless Legs Syndrome 3
Alcohol Use Disorder 1
Restless Leg Syndrome 1
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Condition MeSH

Condition MeSH for Horizant
Intervention Trials
Restless Legs Syndrome 8
Syndrome 4
Psychomotor Agitation 4
Alzheimer Disease 1
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Clinical Trial Locations for Horizant

Trials by Country

Trials by Country for Horizant
Location Trials
United States 52
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Trials by US State

Trials by US State for Horizant
Location Trials
California 5
South Carolina 4
Pennsylvania 4
Tennessee 4
New York 3
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Clinical Trial Progress for Horizant

Clinical Trial Phase

Clinical Trial Phase for Horizant
Clinical Trial Phase Trials
Phase 4 6
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Horizant
Clinical Trial Phase Trials
Recruiting 5
Not yet recruiting 2
Active, not recruiting 1
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Clinical Trial Sponsors for Horizant

Sponsor Name

Sponsor Name for Horizant
Sponsor Trials
XenoPort, Inc. 6
University of Missouri-Columbia 1
Cleveland Sleep Research Center 1
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Sponsor Type

Sponsor Type for Horizant
Sponsor Trials
Other 6
Industry 6
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
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Dow
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Harvard Business School
Fish and Richardson
Chinese Patent Office
Daiichi Sankyo

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