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

Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge

Phase 2
Recruiting
Conditions
Fragile X Syndrome
Interventions
First Posted Date
2022-06-14
Last Posted Date
2024-07-08
Lead Sponsor
Children's Hospital Medical Center, Cincinnati
Target Recruit Count
45
Registration Number
NCT05418049
Locations
🇺🇸

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial

Not Applicable
Completed
Conditions
Lumbar Spinal Stenosis With Nocturnal Calf Cramps
Interventions
First Posted Date
2022-05-26
Last Posted Date
2023-03-30
Lead Sponsor
Yonsei University
Target Recruit Count
40
Registration Number
NCT05392361
Locations
🇰🇷

Yonsei University Health System, Severance Hospital, Seoul, Korea, Republic of

Pharmacokinetic and Bioequivalence Comparison of Baclofen and Chlorzoxazone Administered Individually or Concurrently

First Posted Date
2022-02-25
Last Posted Date
2023-03-31
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
19
Registration Number
NCT05257447
Locations
🇺🇸

UT Southwestern Medical Center, Dallas, Texas, United States

Evaluating the Safety of Acute Baclofen in Methadone-maintained Individuals With Opiate Dependence.

Phase 4
Completed
Conditions
Addiction Opiate
Interventions
First Posted Date
2021-12-17
Last Posted Date
2024-11-18
Lead Sponsor
Imperial College London
Target Recruit Count
16
Registration Number
NCT05161351
Locations
🇬🇧

Imperial College Healthcare Trust, London, United Kingdom

Baclocur® Post-Authorisation Safety Study in Real-life Settings in France

Recruiting
Conditions
Alcohol Use Disorder
Interventions
First Posted Date
2020-12-22
Last Posted Date
2021-01-05
Lead Sponsor
Ethypharm
Target Recruit Count
975
Registration Number
NCT04679142
Locations
🇫🇷

CHU Dijon, Dijon, France

Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

Not Applicable
Terminated
Conditions
Cirrhosis
Interventions
First Posted Date
2020-08-12
Last Posted Date
2022-04-29
Lead Sponsor
Mansoura University
Target Recruit Count
5
Registration Number
NCT04509336
Locations
🇪🇬

Tanta University Hospitals, Tanta, Egypt

Effects of Baclofen on Presynaptic Inhibition in Humans

Phase 2
Withdrawn
Conditions
Spasticity, Muscle
Spinal Cord Injuries
Interventions
First Posted Date
2020-07-15
Last Posted Date
2022-04-07
Lead Sponsor
University of Alberta
Registration Number
NCT04471714
Locations
🇨🇦

524 HMRC, University of Alberta, Edmonton, Alberta, Canada

Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers

Phase 2
Terminated
Conditions
Acute Pain
Analgesia
Interventions
First Posted Date
2020-02-05
Last Posted Date
2025-04-06
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
15
Registration Number
NCT04251819
Locations
🇺🇸

University of Alabama, Birmingham, Birmingham, Alabama, United States

The Effect of Oral Baclofen and Botulinum Toxin Treatments in Hemiplegic Spasticity on the Nociceptive Flexor Reflex

Phase 4
Completed
Conditions
Stroke Sequelae
Spastic Hemiplegia
Interventions
Diagnostic Test: Nociceptor flexor reflex
First Posted Date
2019-03-04
Last Posted Date
2021-06-18
Lead Sponsor
Mustafa Kemal University
Target Recruit Count
29
Registration Number
NCT03860662
Locations
🇹🇷

Hatay Mustafa Kemal University, Hatay, Turkey

A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response

Not Applicable
Completed
Conditions
Gastro Esophageal Reflux
Interventions
Other: Placebos
First Posted Date
2019-02-08
Last Posted Date
2019-02-08
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Target Recruit Count
60
Registration Number
NCT03835442
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