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Arbaclofen

DRUG16 trials

Sponsors

Seaside Therapeutics, Inc., RVL Pharmaceuticals, Inc., Celso Arango, MD, PhD, Holland Bloorview Kids Rehabilitation Hospital, Clinical Research Associates, LLC

Conditions

16P11.2 Deletion SyndromeAutism Spectrum DisorderAutism Spectrum DisordersFragile X SyndromeMultiple SclerosisSpasticitySpasticity, Muscle

Phase 2

Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders
CompletedNCT00846547
Seaside Therapeutics, Inc.Autism Spectrum Disorders
Start: 2009-02-28End: 2010-09-30Updated: 2013-06-14
An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome
TerminatedNCT01013480
Seaside Therapeutics, Inc.Fragile X Syndrome
Start: 2009-11-30End: 2012-12-31Updated: 2012-12-20
An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders
TerminatedNCT01064973
Seaside Therapeutics, Inc.Autism Spectrum Disorders
Start: 2010-02-28End: 2012-12-31Updated: 2012-12-20
Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders
CompletedNCT01288716
Seaside Therapeutics, Inc.Autism Spectrum Disorders
Start: 2011-05-31End: 2012-09-30Updated: 2013-07-31
Arbaclofen in Children and Adolescents With ASD
CompletedNCT03682978
Celso Arango, MD, PhDAutism Spectrum Disorder
Start: 2019-09-19End: 2023-01-27Updated: 2023-02-08
Arbaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD (ARBA)
CompletedNCT03887676
Holland Bloorview Kids Rehabilitation HospitalAutism Spectrum Disorder
Start: 2019-03-18End: 2023-08-04Updated: 2025-07-16
Safety, Tolerability, and Efficacy of Arbaclofen in 16p11.2 Deletion
Active, not recruitingNCT04271332
Clinical Research Associates, LLC16P11.2 Deletion Syndrome
Start: 2022-09-01End: 2025-03-23Target: 60Updated: 2024-05-30

Phase 3

Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome
CompletedNCT01282268
Seaside Therapeutics, Inc.Fragile X Syndrome
Start: 2011-05-31Updated: 2013-07-31
Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome
CompletedNCT01325220
Seaside Therapeutics, Inc.Fragile X Syndrome
Start: 2011-06-30Updated: 2013-07-31
An Open Label Extension Study in Subjects With Fragile X Syndrome
TerminatedNCT01555333
Seaside Therapeutics, Inc.Fragile X Syndrome
Start: 2011-11-30End: 2013-07-31Updated: 2013-07-31
Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis
CompletedNCT01743651
RVL Pharmaceuticals, Inc.Multiple Sclerosis, Spasticity
Start: 2012-11-30End: 2014-04-30Updated: 2022-04-25
One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity
CompletedNCT01844232
RVL Pharmaceuticals, Inc.Multiple Sclerosis, Spasticity
Start: 2013-04-30End: 2015-01-31Updated: 2022-04-25
A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS
CompletedNCT03290131
RVL Pharmaceuticals, Inc.Multiple Sclerosis, Spasticity, Muscle
Start: 2018-01-28End: 2019-01-02Updated: 2022-07-15
A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS
CompletedNCT03319732
RVL Pharmaceuticals, Inc.Multiple Sclerosis, Spasticity, Muscle
Start: 2018-04-03End: 2020-06-11Updated: 2022-08-09
A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis
Not yet recruitingNCT05179577
RVL Pharmaceuticals, Inc.Spasticity
Start: 2027-01-31End: 2028-04-30Target: 442Updated: 2025-12-03
Single Dose Double-blind, Placebo-controlled Cross-over (SDDBPCCO) Shiftability Study, Will be Followed by a 10-week Open-label Study With Arbaclofen (4 Weeks of Titration and Then 6 Weeks of Active/Stable Treatment). The Effects of Arbaclofen on Target EEG and ERG Metrics Will be Associated With th
RecruitingNCT07655115
Hospital General Universitario Gregorio MarañonAutism Spectrum Disorders
Start: 2025-11-20End: 2026-12-31Target: 103Updated: 2026-06-17

Related Papers

Rationale and study design for the first precision medicine randomized placebo-controlled trial in the 16p11.2 deletion syndrome
Figshare2026-05-04
Rationale and study design for the first precision medicine randomized placebo-controlled trial in the 16p11.2 deletion syndrome
Expert Review of Neurotherapeutics2026-05-04
Rationale and study design for the first precision medicine randomized placebo-controlled trial in the 16p11.2 deletion syndrome
Figshare2026-05-04
Arbaclofen extended-release tablets for spasticity in multiple sclerosis: open-label extension study
Brain Communications2022-12-291 citations
A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Arbaclofen Administered for the Treatment of Social Function in Children and Adolescents With Autism Spectrum Disorders: Study Protocol for AIMS-2-TRIALS-CT1
Frontiers in Psychiatry2021-08-2431 citations
A combination of ascorbic acid and α-tocopherol to test the effectiveness and safety in the fragile X syndrome: study protocol for a phase II, randomized, placebo-controlled trial.
2014-09-038 citations