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
Associated Therapies
-

Baclofen for Rumination

Phase 4
Completed
Conditions
Rumination
Supra-gastric Belching
Interventions
Drug: Placebo oral capsule
Drug: Baclofen
First Posted Date
2017-04-13
Last Posted Date
2017-04-13
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Target Recruit Count
20
Registration Number
NCT03113396

Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain

Phase 4
Completed
Conditions
Low Back Pain
Interventions
First Posted Date
2017-03-03
Last Posted Date
2020-08-12
Lead Sponsor
Montefiore Medical Center
Target Recruit Count
320
Registration Number
NCT03068897
Locations
🇺🇸

Montefiore Medical Center, Bronx, New York, United States

Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction

Early Phase 1
Conditions
Drug Abuse
Interventions
First Posted Date
2017-02-28
Last Posted Date
2017-02-28
Lead Sponsor
Ministry of Health, Israel
Target Recruit Count
140
Registration Number
NCT03065998
Locations
🇮🇱

Retorno rehabilitation center, Bet Shemesh, Israel

Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects

Phase 2
Completed
Conditions
Alcohol Use Disorder
Interventions
Drug: Nalmefene
Drug: Baclofen
Drug: Placebo Oral Capsule
First Posted Date
2017-01-27
Last Posted Date
2020-10-29
Lead Sponsor
Prof. Daniele Zullino
Target Recruit Count
37
Registration Number
NCT03034408
Locations
🇨🇭

Service d'Addictologie, Hôpitaux Universitaires de Genève, Geneva, Switzerland

Neurophysiological and Acute Pharmacological Studies in FXS Patients

Early Phase 1
Completed
Conditions
Fragile X Syndrome
Interventions
First Posted Date
2016-12-20
Last Posted Date
2021-11-26
Lead Sponsor
Children's Hospital Medical Center, Cincinnati
Target Recruit Count
29
Registration Number
NCT02998151
Locations
🇺🇸

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

Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU

Phase 3
Completed
Conditions
Alcoholism
Interventions
Drug: PLACEBO
Drug: BACLOFEN
First Posted Date
2016-03-30
Last Posted Date
2020-01-29
Lead Sponsor
Nantes University Hospital
Target Recruit Count
314
Registration Number
NCT02723383
Locations
🇫🇷

CHU de Brest Réanimation Médicale, Brest, France

🇫🇷

Hopital Saint Antoine, Paris, France

🇫🇷

CHU de Caen Réanimation Médicale, Caen, France

and more 15 locations

Phone-based Safety Monitoring of Baclofen Prescriptions for Alcohol Use Disorder

Phase 4
Conditions
Alcohol Use Disorder
Interventions
First Posted Date
2015-11-04
Last Posted Date
2020-08-25
Lead Sponsor
University Hospital, Lille
Target Recruit Count
792
Registration Number
NCT02596763
Locations
🇫🇷

Hospital Center, Valenciennes, France

🇫🇷

Etablissement Public de Santé Mentale (EPSM), Lille, France

🇫🇷

Service d'Aide aux Toxicomanes (SATO-Picardie), Beauvais, France

and more 3 locations

Usage of Baclofen for Sleep Improvement After Cardiac Surgery

Phase 4
Suspended
Conditions
Sleep
Interventions
Drug: Placebo
Drug: Baclofen
First Posted Date
2015-08-20
Last Posted Date
2016-05-13
Lead Sponsor
University of Liege
Target Recruit Count
30
Registration Number
NCT02529514
Locations
🇧🇪

Centre Hospitalier Universitaire de Liège, Liège, Belgium

Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment

Phase 4
Completed
Conditions
Muscle Spasticity
Interventions
Drug: botulinum A toxin
Drug: Baclofen
Drug: Placebo toxin
Drug: placebo baclofen
First Posted Date
2015-06-04
Last Posted Date
2021-02-01
Lead Sponsor
University Hospital, Toulouse
Target Recruit Count
184
Registration Number
NCT02462317
Locations
🇫🇷

University Hospital Dijon, Dijon, France

🇫🇷

Groupe Hospitalier Pitié-Salpêtrière, Paris, France

🇫🇷

Centre Bouffard- Vercelli, Cerbere, France

and more 16 locations

Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study

Phase 2
Completed
Conditions
Muscle Cramps
Cirrhosis
Interventions
First Posted Date
2014-11-24
Last Posted Date
2015-02-05
Lead Sponsor
University of Virginia
Target Recruit Count
10
Registration Number
NCT02298868
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