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

Baclofen Effects on Marijuana Dependence

Phase 2
Completed
Conditions
Marijuana Dependence
Interventions
Behavioral: Psychosocial
Drug: Placebo
First Posted Date
2013-12-13
Last Posted Date
2017-06-14
Lead Sponsor
University of Pennsylvania
Target Recruit Count
47
Registration Number
NCT02011516
Locations
🇺🇸

University of Pennsylvania Center for Studies of Addiction, Philadelphia, Pennsylvania, United States

A Study of Baclofen ER

Phase 2
Withdrawn
Conditions
Cocaine Dependence
Interventions
Drug: Placebo
First Posted Date
2013-12-06
Last Posted Date
2016-09-08
Lead Sponsor
University of Pennsylvania
Registration Number
NCT02003664
Locations
🇺🇸

Center for the Studies of Addiction, Philadelphia, Pennsylvania, United States

A Study to Examine the, Safety, Tolerability and Pharmacokinetics Co-Administered Baclofen and Memantine in Obese and Lean, Otherwise Healthy Adults

Phase 1
Completed
Conditions
Healthy Volunteers;
Obese, Otherwise Healthy Volunteers
Interventions
First Posted Date
2013-12-05
Last Posted Date
2014-07-08
Lead Sponsor
Gedeon Richter Plc.
Registration Number
NCT02001584
Locations
🇬🇧

Quintiles Drug Research Unit at Guy's Hospital, London, United Kingdom

Efficacy and Safety of High Dose Baclofen for Alcohol Dependence

Phase 2
Completed
Conditions
Alcoholism
Interventions
Drug: Placebo
First Posted Date
2013-11-11
Last Posted Date
2019-06-12
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
120
Registration Number
NCT01980706
Locations
🇺🇸

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Recurrent Crying Spells in Cerebral Palsy

Phase 4
Completed
Conditions
Recurrent Crying Spells
Interventions
Other: Placebo
First Posted Date
2013-10-07
Last Posted Date
2013-10-08
Lead Sponsor
Sathbhavana Brain Clinic
Target Recruit Count
70
Registration Number
NCT01955655
Locations
🇮🇳

Sathbhavana Brain Clinic, Secunderabad, Andhra Pradesh, India

Preventing Alcohol Withdrawal With Oral Baclofen

Phase 2
Terminated
Conditions
Alcoholism
Alcohol Withdrawal
Interventions
Drug: Placebo
First Posted Date
2013-09-09
Last Posted Date
2017-05-05
Lead Sponsor
Essentia Health
Target Recruit Count
17
Registration Number
NCT01937364
Locations
🇺🇸

St. Mary's Medical Center, Duluth, Minnesota, United States

🇺🇸

Essentia Health Innovis Hospital, Fargo, North Dakota, United States

Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers

Phase 1
Completed
Conditions
Safety and Pharmacokinetics of Intravenous Baclofen
Interventions
First Posted Date
2013-08-29
Last Posted Date
2019-05-07
Lead Sponsor
University of Minnesota
Target Recruit Count
39
Registration Number
NCT01931319
Locations
🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

Baclofen Effects in Cigarette Smokers

Phase 2
Completed
Conditions
Nicotine Dependence
Interventions
Drug: placebo
First Posted Date
2013-04-01
Last Posted Date
2018-12-19
Lead Sponsor
University of Pennsylvania
Target Recruit Count
44
Registration Number
NCT01821560
Locations
🇺🇸

University of Pennsylvania Center for Studies of Addiction, Philadelphia, Pennsylvania, United States

Baclofen for Treating Anxiety and Alcoholism

Phase 2
Completed
Conditions
Alcohol Dependence
Alcohol Drinking
Anxiety Disorder
Alcoholism
Alcohol Drinking Related Problems
Interventions
Other: Placebo
First Posted Date
2012-12-18
Last Posted Date
2017-09-18
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Target Recruit Count
39
Registration Number
NCT01751386
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Oral and IV Baclofen in Adult Volunteers

Phase 1
Completed
Conditions
Baclofen Withdrawal Syndrome
Interventions
First Posted Date
2012-12-13
Last Posted Date
2014-08-05
Lead Sponsor
University of Minnesota
Target Recruit Count
12
Registration Number
NCT01749319
Locations
🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

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