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

Effectiveness of Baclofen in the Treatment of People With Bulimia Nervosa or Binge Eating Disorder

Not Applicable
Completed
Conditions
Eating Disorders
Bulimia Nervosa
Interventions
First Posted Date
2006-04-27
Last Posted Date
2013-08-12
Lead Sponsor
New York State Psychiatric Institute
Target Recruit Count
10
Registration Number
NCT00320047
Locations
🇺🇸

Eating Disorders Clinic, New York State Psychiatric Institute, New York, New York, United States

Baclofen Effects on Smoking Urge and Withdrawal

Phase 2
Terminated
Conditions
Nicotine Dependence
Nicotine Use Disorder
Tobacco Use Disorder
Smoking
Interventions
Drug: Placebo
First Posted Date
2005-11-23
Last Posted Date
2015-11-04
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
41
Registration Number
NCT00257894
Locations
🇺🇸

VA Medical Center, Providence, Providence, Rhode Island, United States

Does Reducing Spasticity Permit an Increase in Strength?

Phase 2
Completed
Conditions
Spastic Diplegic Cerebral Palsy
First Posted Date
2005-11-17
Last Posted Date
2014-05-23
Lead Sponsor
University of Southern California
Target Recruit Count
10
Registration Number
NCT00255073
Locations
🇺🇸

Stanford University, Stanford, California, United States

Intrathecal Baclofen Therapy and Paroxysmal Dysautonomia in Severe Brain-Injured Patients

Phase 2
Terminated
Conditions
Traumatic Brain Injury
Cerebral Anoxia
Coma
Hypertonia
Dysautonomia
First Posted Date
2005-09-22
Last Posted Date
2007-06-13
Lead Sponsor
University Hospital, Bordeaux
Target Recruit Count
4
Registration Number
NCT00221689
Locations
🇫🇷

Service de neurochirurgie B, Hôpital Pellergin Tripode, Bordeaux, France

A Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis

Phase 3
Completed
Conditions
Multiple Sclerosis
First Posted Date
2005-08-31
Last Posted Date
2013-08-30
Lead Sponsor
UCB Pharma
Target Recruit Count
60
Registration Number
NCT00139789
Locations
🇺🇸

Schwarz, Milwaukee, Wisconsin, United States

Baclofen for the Treatment of Cocaine Dependence - 1

Phase 2
Completed
Conditions
Cocaine-Related Disorders
Interventions
Other: Placebo
First Posted Date
2004-05-12
Last Posted Date
2017-01-12
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Target Recruit Count
160
Registration Number
NCT00082485
Locations
🇺🇸

San Francisco General Hosptial, San Francisco, California, United States

🇺🇸

Denver VA Medical Center, Denver, Colorado, United States

🇺🇸

South TX VA Health Care System, San Antonio, Texas, United States

and more 5 locations

Rapid Evaluation of Baclofen for Treatment of Cocaine Abuse/Dependence - 6

Phase 2
Completed
Conditions
Cocaine-Related Disorders
First Posted Date
1999-09-21
Last Posted Date
2016-07-11
Lead Sponsor
University of California, Los Angeles
Registration Number
NCT00000303
Locations
🇺🇸

Friends Research Institute, Los Angeles, California, United States

© Copyright 2025. All Rights Reserved by MedPath