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CLINICAL TRIALS PROFILE FOR HORIZANT

All Clinical Trials for Horizant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01533753 ↗	Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer	Terminated	University of Wisconsin, Madison	Phase 2	2012-02-01	The purpose of this study is to assess the change in quality of life over a 6 month period between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy.
NCT01668667 ↗	Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study	Completed	XenoPort, Inc.	Phase 4	2012-06-01	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).
NCT01675960 ↗	Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children	Terminated	Gillette Children's Specialty Healthcare	Phase 2	2012-04-01	This study is a prospective, randomized, double blind, placebo controlled, crossover clinical trial looking at whether gabapentin can provide symptom relief for chronic irritability in neurologically impaired children. The investigators hypothesize gabapentin ins beneficial and safe for children with chronic irritability that persists despite identification and appropriate management of symptom sources.

Clinical Trial Conditions for Horizant

Condition Name

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

Condition MeSH

Condition MeSH for Horizant
Intervention	Trials
Restless Legs Syndrome	8
Syndrome	4
Psychomotor Agitation	4

Clinical Trial Locations for Horizant

Trials by Country

Trials by Country for Horizant
Location	Trials
United States	67

Trials by US State

Trials by US State for Horizant
Location	Trials
California	6
Texas	5
Florida	5
Tennessee	4
South Carolina	4

Clinical Trial Progress for Horizant

Clinical Trial Phase

Clinical Trial Phase for Horizant
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Horizant
Clinical Trial Phase	Trials
Completed	5
Terminated	4
Recruiting	3

Clinical Trial Sponsors for Horizant

Sponsor Name

Sponsor Name for Horizant
Sponsor	Trials
XenoPort, Inc.	6
University of Wisconsin, Madison	1
Massachusetts General Hospital	1

Sponsor Type

Sponsor Type for Horizant
Sponsor	Trials
Other	11
Industry	8
NIH	2