MedPath

Baclofen

Generic Name
Baclofen
Brand Names
Fleqsuvy, Gablofen, Kemstro, Lioresal, Lyvispah, Ozobax
Drug Type
Small Molecule
Chemical Formula
C10H12ClNO2
CAS Number
1134-47-0
Unique Ingredient Identifier
H789N3FKE8
Background

Baclofen is a gamma-aminobutyric acid (GABA) agonist used as a skeletal muscle relaxant. Although originally designed in 1962 to treat epilepsy, baclofen was not effective in treating this condition but instead was shown to reduce spasticity in selected patients. Baclofen was reintroduced in 1971 as a treatment for spasticity and was later approved by the FDA in 1977. Baclofen is used to manage severe muscle spasms of cerebral or spinal cord origins, including multiple sclerosis and traumatic brain injury.

Baclofen was investigated for use in alcohol dependence and withdrawal; however, evidence is limited and there is inconsistent evidence to suggest its clinical efficacy in managing alcohol dependence or withdrawal symptoms.

Indication

Oral baclofen is indicated for the treatment of spasticity resulting from multiple sclerosis and is particularly useful for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. It may also be used to treat patients with spinal cord injuries and other spinal cord diseases. Baclofen should not be used to treat skeletal muscle spasms resulting from rheumatic disorders.

Intrathecal baclofen is also indicated for the management of severe spasticity of the cerebral or spinal original in patients 4 years of age and older. It is reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable central nervous system side effects at effective doses. For use in spasticity due to traumatic brain injury, baclofen should be considered after at least one year of injury.

Associated Conditions
Alcohol Dependency, Severe Spasticity, Spasticity, Flexor spasm, Severe cerebral origin Spasticity, Severe spinal cord origin Spasticity

Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

Phase 3
Completed
Conditions
Spasticity
Multiple Sclerosis
Interventions
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

Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients

Phase 3
Completed
Conditions
Alcohol Dependence
Interventions
Drug: Placebo (for baclofen)
First Posted Date
2012-11-30
Last Posted Date
2014-07-30
Lead Sponsor
Ethypharm
Target Recruit Count
316
Registration Number
NCT01738282
Locations
🇫🇷

Hopital Beaujon, Clichy, France

🇫🇷

CHU, Nantes, France

🇫🇷

Centre hospitalier, Pont du Casse, France

and more 16 locations

Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease

Phase 3
Completed
Conditions
Alcoholic Liver Disease
Alcohol Dependence
Interventions
First Posted Date
2012-10-22
Last Posted Date
2017-08-08
Lead Sponsor
South West Sydney Local Health District
Target Recruit Count
104
Registration Number
NCT01711125
Locations
🇦🇺

Drug Health Services, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

Baclofen for the Treatment of Alcohol Drinkers

Phase 2
Completed
Conditions
Alcoholism
Interventions
Drug: Placebo
First Posted Date
2012-05-23
Last Posted Date
2017-10-03
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
323
Registration Number
NCT01604330
Locations
🇫🇷

Paris Descartes University, Paris, France

GABA-B Receptor Function in Healthy Volunteers

Not Applicable
Completed
Conditions
No Condition
Brain GABA-B Function
Interventions
First Posted Date
2012-03-26
Last Posted Date
2015-06-04
Lead Sponsor
Imperial College London
Target Recruit Count
8
Registration Number
NCT01563224
Locations
🇬🇧

Neuropsychopharmacology, Imperial College, London, United Kingdom

Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump

Phase 3
Completed
Conditions
Severe Spasticity
Interventions
Device: SynchroMed® II Programmable Pump
First Posted Date
2012-01-30
Last Posted Date
2019-05-03
Lead Sponsor
Piramal Critical Care, Ltd.
Target Recruit Count
153
Registration Number
NCT01520545
Locations
🇺🇸

Wayne State University, School of Medicine, Dearborn, Michigan, United States

🇺🇸

Rehabilitation Medicine Department, University of Miami, Miller School of Medicine, Miami, Florida, United States

🇺🇸

University of Utah, Division of PM&R, Salt Lake City, Utah, United States

and more 10 locations

Efficacy and Safety of SPARC0921 in Subjects With Spasticity

Phase 3
Completed
Conditions
Spasticity
Interventions
Drug: Placebo0921
First Posted Date
2011-10-21
Last Posted Date
2019-06-18
Lead Sponsor
Sun Pharma Advanced Research Company Limited
Target Recruit Count
392
Registration Number
NCT01457352
Locations
🇺🇸

SPARC Site 56, Columbus, Ohio, United States

🇺🇸

SPARC Site 17, Port Charlotte, Florida, United States

🇺🇸

SPARC Site 36, Costa Mesa, California, United States

and more 70 locations

Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy

Phase 4
Withdrawn
Conditions
Cerebral Palsy
GERD
Interventions
Drug: placebo
First Posted Date
2011-07-01
Last Posted Date
2017-08-29
Lead Sponsor
Boston Children's Hospital
Registration Number
NCT01386255
Locations
🇺🇸

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

Baclofen for the Treatment of Alcohol Dependence

Phase 2
Completed
Conditions
Alcohol Dependence
Interventions
Drug: Placebo
First Posted Date
2010-12-24
Last Posted Date
2014-09-05
Lead Sponsor
Charite University, Berlin, Germany
Target Recruit Count
56
Registration Number
NCT01266655
Locations
🇩🇪

Department of Psychiatry, Charité Campus Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany

A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors

Phase 3
Completed
Conditions
GERD
Interventions
Device: Nissen fundoplication
First Posted Date
2010-12-23
Last Posted Date
2020-01-22
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
366
Registration Number
NCT01265550
Locations
🇺🇸

Birmingham VA Medical Center, Birmingham, AL, Birmingham, Alabama, United States

🇺🇸

VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda, California, United States

🇺🇸

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston, Massachusetts, United States

and more 12 locations
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