Arbaclofen

Generic Name
Arbaclofen
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C10H12ClNO2
CAS Number
69308-37-8
Unique Ingredient Identifier
NYU6UTW25B
Background

Arbaclofen, or STX209, is the R-enantiomer of baclofen. It is believed to be a selective gamma-amino butyric acid type B receptor agonist, and has been investigated as a treatment for autism spectrum disorder and fragile X syndrome in randomized, double blind, placebo controlled trials. It has also been investigated as a treatment for spasticity due to multi...

Indication

Investigated in clinical trials as a potential treatment for spasticity in multiple sclerosis, autism spectrum disorder, and social withdrawal in fragile X syndrome.

Associated Conditions
-
Associated Therapies
-

A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis

Phase 3
Not yet recruiting
Conditions
Interventions
First Posted Date
2022-01-05
Last Posted Date
2024-08-21
Lead Sponsor
RVL Pharmaceuticals, Inc.
Target Recruit Count
442
Registration Number
NCT05179577

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

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-02-17
Last Posted Date
2024-05-30
Lead Sponsor
Clinical Research Associates, LLC
Target Recruit Count
60
Registration Number
NCT04271332
Locations
🇺🇸

New York State Psychiatric Institute (NYSPI), New York, New York, United States

🇺🇸

Texas Children's Hospital, Houston, Texas, United States

🇺🇸

Boston Children's Hospital, Boston, Massachusetts, United States

and more 1 locations

Arbaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD (ARBA)

First Posted Date
2019-03-25
Last Posted Date
2022-06-22
Lead Sponsor
Evdokia Anagnostou
Target Recruit Count
90
Registration Number
NCT03887676
Locations
🇨🇦

McMaster University, Offord Centre for Child Studies, Hamilton, Ontario, Canada

🇨🇦

Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, Canada

🇨🇦

Queen's Universtiy, Kingston, Ontario, Canada

and more 1 locations

Arbaclofen in Children and Adolescents With ASD

Phase 2
Completed
Conditions
Interventions
First Posted Date
2018-09-25
Last Posted Date
2023-02-08
Lead Sponsor
Celso Arango, MD, PhD
Target Recruit Count
124
Registration Number
NCT03682978
Locations
🇬🇧

King's College London, London, United Kingdom

🇫🇷

Robert Debré Hospital, Paris, France

🇪🇸

Servicio de Psiquiatría del Niño y del Adolescente, Hospital General Universitario Gregorio Marañón, SERMAS, Madrid, Spain

and more 4 locations

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

Phase 3
Completed
Conditions
Interventions
First Posted Date
2017-10-24
Last Posted Date
2022-08-09
Lead Sponsor
RVL Pharmaceuticals, Inc.
Target Recruit Count
323
Registration Number
NCT03319732
Locations
🇺🇸

Neuro Pain Medical Center, Fresno, California, United States

A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS

First Posted Date
2017-09-21
Last Posted Date
2022-07-15
Lead Sponsor
RVL Pharmaceuticals, Inc.
Target Recruit Count
536
Registration Number
NCT03290131
Locations
🇵🇱

Neuro-Medic, Katowice, Poland

🇵🇱

"MEDYK" Stanislaw Mazur Sp. z o.o. (LLC) Medical Centre, Rzeszów, Poland

🇵🇱

Neurology Center Krzysztof Selmaj, Łódź, Poland

and more 27 locations

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

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-05-01
Last Posted Date
2022-04-25
Lead Sponsor
RVL Pharmaceuticals, Inc.
Target Recruit Count
150
Registration Number
NCT01844232
Locations
🇷🇺

Osmotica Study Site-555, Tonnel'nyy, Russian Federation

🇺🇸

Osmotica Study Site-161, Plainview, New York, United States

🇺🇸

Osmotica Study Site-155, Raleigh, North Carolina, United States

and more 32 locations

Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

First Posted Date
2012-12-06
Last Posted Date
2022-04-25
Lead Sponsor
RVL Pharmaceuticals, Inc.
Target Recruit Count
353
Registration Number
NCT01743651
Locations
🇺🇸

Osmotica Study Site-127, Pittsburgh, Pennsylvania, United States

🇺🇸

Osmotica Study Site-129, Seattle, Washington, United States

🇺🇸

Osmotica Study Site-131, Cincinnati, Ohio, United States

and more 44 locations

An Open Label Extension Study in Subjects With Fragile X Syndrome

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2012-03-15
Last Posted Date
2013-07-31
Lead Sponsor
Seaside Therapeutics, Inc.
Target Recruit Count
357
Registration Number
NCT01555333
Locations
🇺🇸

Seaside Therapeutics Site #20, Decatur, Georgia, United States

🇺🇸

Seaside Therapeutics Site #05, Akron, Ohio, United States

🇺🇸

Seaside Therapeutics Site #12, Baltimore, Maryland, United States

and more 20 locations

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

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-03-29
Last Posted Date
2013-07-31
Lead Sponsor
Seaside Therapeutics, Inc.
Target Recruit Count
172
Registration Number
NCT01325220
Locations
🇺🇸

New York State Institute for Basic Research in Developmental Disabilities, Staten Island, New York, United States

🇺🇸

Kennedy Krieger Institute, Baltimore, Maryland, United States

🇺🇸

University of Massachusetts, Worcester, Massachusetts, United States

and more 25 locations
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