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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

Effect of Low-Dose Baclofen Administration on the GH-IGF1 Axis Study

Not Applicable
Completed
Conditions
Spinal Cord Injury
Interventions
First Posted Date
2009-03-30
Last Posted Date
2012-04-02
Lead Sponsor
US Department of Veterans Affairs
Target Recruit Count
20
Registration Number
NCT00871455
Locations
🇺🇸

VA Medical Center, Bronx, Bronx, New York, United States

ALK29-002: A Study of Baclofen Formulations in Healthy Adults

Phase 1
Completed
Conditions
Alcohol Dependence
Interventions
First Posted Date
2008-12-04
Last Posted Date
2011-08-23
Lead Sponsor
Alkermes, Inc.
Target Recruit Count
16
Registration Number
NCT00802035
Locations
🇺🇸

CEDRA Clinical Research, LLC, Austin, Texas, United States

Comparative Bioavailability Study of Baclofen 20 mg Tablets in Healthy Male Volunteers / Fasting State

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2008-04-01
Last Posted Date
2024-04-24
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
27
Registration Number
NCT00647738
Locations
🇨🇦

Algorithme Pharma, Montreal, Quebec, Canada

Baclofen Treatment of Ataxia Telangiectasia

Early Phase 1
Completed
Conditions
Ataxia Telangiectasia
Interventions
Drug: Placebo
First Posted Date
2008-03-20
Last Posted Date
2017-12-20
Lead Sponsor
Johns Hopkins University
Target Recruit Count
10
Registration Number
NCT00640003
Locations
🇺🇸

Johns Hopkins Hospital, Baltimore, Maryland, United States

Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity

Phase 1
Completed
Conditions
Spasticity
Cerebral Palsy
Interventions
First Posted Date
2008-02-05
Last Posted Date
2011-12-06
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Target Recruit Count
61
Registration Number
NCT00607542
Locations
🇺🇸

Kennedy Krieger Institute, Baltimore, Maryland, United States

🇺🇸

Washington Univeristy - St. Louis Children's hospital, St. Louis, Missouri, United States

🇺🇸

SUNY Upstate Medical University, Syracuse, New York, United States

and more 8 locations

Treating Alcohol Withdrawal With Oral Baclofen

Not Applicable
Completed
Conditions
Alcohol Withdrawal Delirium
Interventions
First Posted Date
2008-01-18
Last Posted Date
2011-07-27
Lead Sponsor
Essentia Health
Target Recruit Count
79
Registration Number
NCT00597701
Locations
🇺🇸

Essentia Health, Duluth, Minnesota, United States

Efficacy of Baclofen in the Treatment of Alcohol Addiction

Phase 1
Completed
Conditions
Liver Cirrhosis, Alcoholic
Interventions
Drug: placebo
First Posted Date
2007-09-05
Last Posted Date
2007-09-05
Lead Sponsor
Catholic University of the Sacred Heart
Target Recruit Count
86
Registration Number
NCT00525252

Treatment of Non-Metastatic Hepatocellular Carcinoma in Humans by Increasing Gabaergic Activity: A Pilot Study

Phase 2
Withdrawn
Conditions
Hepatocellular Carcinoma
First Posted Date
2007-06-28
Last Posted Date
2014-05-16
Lead Sponsor
University of Manitoba
Registration Number
NCT00493428
Locations
🇨🇦

Liver Unit, Section of Hepatology, Department of Medicine,Health Sciences Centre, Winnipeg, Manitoba, Canada

🇨🇦

Liver Unit, health sciences Centre, Winnipeg, Manitoba, Canada

IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis

Phase 3
Completed
Conditions
Multiple Sclerosis
Interventions
Drug: IPX056 20 mg
Drug: IPX056 40 mg
Drug: IPX056 10 mg
Drug: IPX056 30 mg
Drug: IPX056 35 mg
Drug: Placebo IPX056 40 mg
Drug: Placebo IPX056 20 mg
First Posted Date
2007-06-20
Last Posted Date
2019-11-06
Lead Sponsor
Impax Laboratories, LLC
Target Recruit Count
173
Registration Number
NCT00488839
Locations
🇺🇸

Northwest NeuroSpecialists, Tucson, Arizona, United States

🇺🇸

OrthoArkansas, P. A., Little Rock, Arkansas, United States

🇺🇸

OrthoArkansas, P.A., Little Rock, Arkansas, United States

and more 28 locations

Effect of Baclofen on Marijuana Withdrawal and Relapse

Phase 2
Completed
Conditions
Marijuana Dependence
Interventions
First Posted Date
2006-09-08
Last Posted Date
2017-05-10
Lead Sponsor
New York State Psychiatric Institute
Target Recruit Count
13
Registration Number
NCT00373295
Locations
🇺🇸

New York State Psychiatric Institute, New York, New York, United States

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