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ClinicalTrials.gov public records Last synced Oct 19, 2026, 3:37 PM EDT

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Showing 1–23 of 23 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: arbaclofen Clear all
Completed Phase 2 Interventional

Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders

NCT01288716
View directory record Official record
Conditions
Autism Spectrum Disorders
Interventions
Arbaclofen
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
5 Years to 21 Years
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2012
U.S. locations
24
States / cities
Phoenix, Arizona • Los Angeles, California • Sacramento, California + 21 more
Source: ClinicalTrials.gov public record
Updated Jul 31, 2013 · Synced Oct 19, 2026, 3:37 PM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS

NCT03319732
View directory record Official record
Conditions
Multiple Sclerosis, Spasticity, Muscle
Interventions
Arbaclofen
Drug
Lead sponsor
RVL Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
323 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
1
States / cities
Fresno, California
Source: ClinicalTrials.gov public record
Updated Aug 9, 2022 · Synced Oct 19, 2026, 3:37 PM EDT
Not listed Phase 2 Interventional

Safety, Tolerability, and Efficacy of Arbaclofen in 16p11.2 Deletion

NCT04271332
View directory record Official record
Conditions
16P11.2 Deletion Syndrome
Interventions
Arbaclofen, Placebo oral tablet
Drug
Lead sponsor
Clinical Research Associates, LLC
Other
Eligibility
5 Years to 17 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
4
States / cities
Boston, Massachusetts • New York, New York • Houston, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated May 30, 2024 · Synced Oct 19, 2026, 3:37 PM EDT
Terminated Phase 2 Interventional

An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome

NCT01013480
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
Arbaclofen
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
6 Years to 40 Years
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2012
U.S. locations
9
States / cities
Los Angeles, California • Sacramento, California • Chicago, Illinois + 6 more
Source: ClinicalTrials.gov public record
Updated Dec 20, 2012 · Synced Oct 19, 2026, 3:37 PM EDT
Completed Phase 3 Interventional

Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome

NCT01325220
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
arbaclofen, Placebo
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
5 Years to 11 Years
Enrollment
172 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2011
U.S. locations
28
States / cities
Phoenix, Arizona • Long Beach, California • Sacramento, California + 24 more
Source: ClinicalTrials.gov public record
Updated Jul 31, 2013 · Synced Oct 19, 2026, 3:37 PM EDT
Completed Phase 2 Interventional Results available

Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome

NCT00788073
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
STX209, Placebo
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
6 Years to 40 Years
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
12
States / cities
Phoenix, Arizona • Los Angeles, California • Sacramento, California + 9 more
Source: ClinicalTrials.gov public record
Updated May 6, 2013 · Synced Oct 19, 2026, 3:37 PM EDT
Completed Phase 2 Interventional Results available

Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders

NCT00846547
View directory record Official record
Conditions
Autism Spectrum Disorders
Interventions
Arbaclofen
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
6 Years to 17 Years
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
8
States / cities
Phoenix, Arizona • Los Angeles, California • New Haven, Connecticut + 5 more
Source: ClinicalTrials.gov public record
Updated Jun 14, 2013 · Synced Oct 19, 2026, 3:37 PM EDT
Terminated Phase 3 Interventional

Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders

NCT01706523
View directory record Official record
Conditions
Autism Spectrum Disorders
Interventions
STX209 (arbaclofen)
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
5 Years to 21 Years
Enrollment
165 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
25
States / cities
Phoenix, Arizona • Los Angeles, California • Sacramento, California + 22 more
Source: ClinicalTrials.gov public record
Updated Jul 31, 2013 · Synced Oct 19, 2026, 3:37 PM EDT
Completed Phase 2 Interventional

A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms

NCT00817986
View directory record Official record
Conditions
Back Pain
Interventions
Arbaclofen placarbil, 20 mg, Placebo, Arbaclofen placarbil, 30 mg, Arbaclofen placarbil, 40 mg
Drug
Lead sponsor
XenoPort, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
161 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
20
States / cities
Litchfield Park, Arizona • Anaheim, California • San Diego, California + 16 more
Source: ClinicalTrials.gov public record
Updated Feb 21, 2021 · Synced Oct 19, 2026, 3:37 PM EDT
Completed Phase 2 Interventional

A Study to Evaluate the Efficacy and Safety of Controlled Release Arbaclofen Placarbil (XP19986) in Patients With Gastroesophageal Reflux Disease

NCT00838396
View directory record Official record
Conditions
GERD
Interventions
XP19986 CR, Placebo for XP19986 CR
Drug
Lead sponsor
Indivior Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
58 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2006
U.S. locations
3
States / cities
Stanford, California • Charleston, South Carolina • Tacoma, Washington
Source: ClinicalTrials.gov public record
Updated Sep 14, 2016 · Synced Oct 19, 2026, 3:37 PM EDT
Withdrawn Phase 3 Interventional

To Assess Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With MS

NCT02869425
View directory record Official record
Conditions
Multiple Sclerosis, Sperm
Interventions
arbaclofen ER Tablets, Placebo for arbaclofen ER tablets
Drug
Lead sponsor
RVL Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 55 Years · Male only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
2
States / cities
Miami, Florida • Tampa, Florida
Source: ClinicalTrials.gov public record
Updated Apr 27, 2022 · Synced Oct 19, 2026, 3:37 PM EDT
Completed No phase listed Observational

Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001

NCT00823368
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
STX209
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
6 Years to 40 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2009
U.S. locations
11
States / cities
Phoenix, Arizona • Los Angeles, California • Sacramento, California + 8 more
Source: ClinicalTrials.gov public record
Updated Jul 31, 2013 · Synced Oct 19, 2026, 3:37 PM EDT
Completed Phase 3 Interventional

Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome

NCT01282268
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
arbaclofen, placebo
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
12 Years to 50 Years
Enrollment
125 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2011
U.S. locations
24
States / cities
Phoenix, Arizona • Long Beach, California • Sacramento, California + 20 more
Source: ClinicalTrials.gov public record
Updated Jul 31, 2013 · Synced Oct 19, 2026, 3:37 PM EDT
Completed Phase 3 Interventional

Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

NCT01743651
View directory record Official record
Conditions
Spasticity, Multiple Sclerosis
Interventions
arbaclofen, baclofen, Placebo
Drug
Lead sponsor
RVL Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
353 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
25
States / cities
Cullman, Alabama • Long Beach, California • Aurora, Colorado + 20 more
Source: ClinicalTrials.gov public record
Updated Apr 25, 2022 · Synced Oct 19, 2026, 3:37 PM EDT
Terminated Phase 2 Interventional

An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders

NCT01064973
View directory record Official record
Conditions
Autism Spectrum Disorders
Interventions
arbaclofen
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
6 Years to 17 Years
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
8
States / cities
Phoenix, Arizona • Los Angeles, California • New Haven, Connecticut + 5 more
Source: ClinicalTrials.gov public record
Updated Dec 20, 2012 · Synced Oct 19, 2026, 3:37 PM EDT
Completed Early Phase 1 Interventional Results available

MEG Study of Acute STX209 Effects in ASD

NCT02278328
View directory record Official record
Conditions
Autism Disorder
Interventions
STX209 (15mg), placebo, STX209 (30mg)
Drug
Lead sponsor
Timothy Roberts
Other
Eligibility
14 Years to 17 Years · Male only
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Oct 21, 2019 · Synced Oct 19, 2026, 3:37 PM EDT
Terminated Phase 1 Interventional Accepts healthy volunteers

TMS Measures of Plasticity and Excitatory/Inhibitory Ratio as Biomarkers: R-baclofen Effects in Normal Volunteers

NCT01172509
View directory record Official record
Conditions
Autism
Interventions
R-baclofen
Drug
Lead sponsor
Gonzalez-Heydrich, Joseph, M.D.
Individual
Eligibility
18 Years to 30 Years
Enrollment
6 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2012
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Aug 21, 2015 · Synced Oct 19, 2026, 3:37 PM EDT
Completed Phase 2 Interventional

A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)

NCT00978016
View directory record Official record
Conditions
Gastroesophageal Reflux Disease
Interventions
arbaclofen placarbil-Cohort 1, Placebo-Cohort 5, arbaclofen placarbil-Cohort 2, arbaclofen placarbil-Cohort 3, arbaclofen placarbil-Cohort 4, PPI
Drug
Lead sponsor
XenoPort, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
460 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
62
States / cities
Huntsville, Alabama • Chandler, Arizona • Mesa, Arizona + 56 more
Source: ClinicalTrials.gov public record
Updated Feb 21, 2021 · Synced Oct 19, 2026, 3:37 PM EDT
Completed Phase 2 Interventional

A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder

NCT02511886
View directory record Official record
Conditions
Alcohol Use Disorder
Interventions
Arbaclofen Placarbil, Placebo
Drug
Lead sponsor
Indivior Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
1
States / cities
Oakland Park, Florida
Source: ClinicalTrials.gov public record
Updated Jan 23, 2017 · Synced Oct 19, 2026, 3:37 PM EDT
Completed Phase 3 Interventional

Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis

NCT01359566
View directory record Official record
Conditions
Multiple Sclerosis
Interventions
Arbaclofen placarbil 15 mg BID, Placebo, Arbaclofen placarbil 30 mg BID, Arbaclofen placarbil 45 mg BID
Drug
Lead sponsor
XenoPort, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
228 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
28
States / cities
Phoenix, Arizona • Tucson, Arizona • Berkeley, California + 25 more
Source: ClinicalTrials.gov public record
Updated Feb 21, 2021 · Synced Oct 19, 2026, 3:37 PM EDT
Completed Phase 2 Interventional

An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD

NCT00557401
View directory record Official record
Conditions
Gastroesophageal Reflux
Interventions
XP19986 SR3, 20 mg QD, XP19986 SR3, 40 mg QD, XP19986 SR3, 60 mg QD, XP19986 SR3, 30 mg BID, Placebo
Drug
Lead sponsor
XenoPort, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
156 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
1
States / cities
Irvine, California
Source: ClinicalTrials.gov public record
Updated Feb 21, 2021 · Synced Oct 19, 2026, 3:37 PM EDT
Completed Phase 3 Interventional

One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity

NCT01844232
View directory record Official record
Conditions
Multiple Sclerosis, Spasticity
Interventions
arbaclofen
Drug
Lead sponsor
RVL Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
21
States / cities
Gilbert, Arizona • Phoenix, Arizona • Pasadena, California + 17 more
Source: ClinicalTrials.gov public record
Updated Apr 25, 2022 · Synced Oct 19, 2026, 3:37 PM EDT
Terminated Phase 3 Interventional

An Open Label Extension Study in Subjects With Fragile X Syndrome

NCT01555333
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
arbaclofen
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
5 Years to 50 Years
Enrollment
357 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
23
States / cities
Phoenix, Arizona • Long Beach, California • Sacramento, California + 20 more
Source: ClinicalTrials.gov public record
Updated Jul 31, 2013 · Synced Oct 19, 2026, 3:37 PM EDT