CLINICAL TRIALS PROFILE FOR ARBACLOFEN

Clinical Trials for Arbaclofen

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00557401 ↗	An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD	Completed	Indivior Inc.	Phase 2	To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with symptomatic GERD
NCT00557401 ↗	An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD	Completed	XenoPort, Inc.	Phase 2	To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with symptomatic GERD
NCT00788073 ↗	Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome	Completed	Seaside Therapeutics, Inc.	Phase 2	The study objective is to explore the efficacy, safety and tolerability of STX209 for treatment of irritability in subjects with FSX. We hypothesize that STX209 will improve irritability and other typical problem behaviors associated with fragile X syndrome. We also hypothesize that STX209 will be safe and well tolerated.
NCT00817986 ↗	A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms	Completed	Indivior Inc.	Phase 2	The purpose of the study is to evaluate safety and tolerability of arbaclofen placarbil sustained release tablets taken every 12 hours compared to placebo in subjects with acute back spasms in the lumbar region.
NCT00817986 ↗	A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms	Completed	XenoPort, Inc.	Phase 2	The purpose of the study is to evaluate safety and tolerability of arbaclofen placarbil sustained release tablets taken every 12 hours compared to placebo in subjects with acute back spasms in the lumbar region.
NCT00838396 ↗	A Study to Evaluate the Efficacy and Safety of Controlled Release Arbaclofen Placarbil (XP19986) in Patients With Gastroesophageal Reflux Disease	Completed	Indivior Inc.	Phase 2	The purpose of the study is to evaluate the efficacy and safety of arbaclofen placarbil (XP19986) compared to placebo in patients with gastroesophageal reflux disease.
NCT00846547 ↗	Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders	Completed	Seaside Therapeutics, Inc.	Phase 2	The study objective is to explore the safety and tolerability of STX209 in subjects with Autism Spectrum Disorders and to obtain preliminary data on several measures of efficacy in treating irritability. We hypothesize that STX209 will be safe and well-tolerated.

Clinical Trial Conditions for Arbaclofen

Condition Name

Condition Name
Intervention	Trials
Multiple Sclerosis	6
Fragile X Syndrome	5
Autism Spectrum Disorder	4
Autism Spectrum Disorders	4

Condition MeSH

Condition MeSH
Intervention	Trials
Autism Spectrum Disorder	8
Child Development Disorders, Pervasive	7
Autistic Disorder	7
Multiple Sclerosis	7

Clinical Trial Locations for Arbaclofen

Trials by Country

Trials by Country
Location	Trials
United States	227
United Kingdom	3
Russian Federation	3
Canada	2
Ukraine	2

Trials by US State

Trials by US State
Location	Trials
California	17
Texas	15
North Carolina	14
Washington	13
Florida	12

Clinical Trial Progress for Arbaclofen

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	11
Phase 2	13
Phase 1	2

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	17
Terminated	5
Unknown status	2

Clinical Trial Sponsors for Arbaclofen

Sponsor Name

Sponsor Name
Sponsor	Trials
Seaside Therapeutics, Inc.	10
Indivior Inc.	7
Osmotica Pharmaceutical US LLC	5

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	27
Other	22