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 to Prevent Agitation in Alcohol Addicted Patients in ICU

Phase 3
Completed
Conditions
Alcoholism
Interventions
Drug: PLACEBO
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

Intrathecal Baclofen (ITB) Bolus on Neuropathic Pain (NP). Preliminary Study.

Not Applicable
Completed
Conditions
Neuropathic Pain
Interventions
First Posted Date
2016-03-11
Last Posted Date
2019-08-08
Lead Sponsor
Institut Guttmann
Target Recruit Count
12
Registration Number
NCT02705950
Locations
🇪🇸

Institut Guttmann, Badalona, Barcelona, Spain

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
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: Placebo toxin
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

Prospective Analgesic Compound Efficacy (PACE) Study

Completed
Conditions
Radiculopathy
Gout
Muscle Spasms
Headache
Arthritis
Synovitis
Migraine
Tendonitis
First Posted Date
2015-03-31
Last Posted Date
2018-02-01
Lead Sponsor
Express Specialty Pharmacy
Target Recruit Count
300
Registration Number
NCT02403687

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

Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis

Not Applicable
Conditions
Liver Cirrhosis
Muscle Cramps
Interventions
First Posted Date
2014-08-20
Last Posted Date
2014-10-06
Lead Sponsor
Tanta University
Target Recruit Count
100
Registration Number
NCT02221570
Locations
🇪🇬

Tanta University Hospital, Tanta, Gharbia, Egypt

Novel Topical Therapies for the Treatment of Genital Pain

Phase 2
Completed
Conditions
Female Genital Diseases
Interventions
First Posted Date
2014-03-28
Last Posted Date
2016-07-15
Lead Sponsor
University of Rochester
Target Recruit Count
9
Registration Number
NCT02099006
Locations
🇺🇸

University of Rochester, Rochester, New York, United States

Preventing Alcohol Withdrawal Syndrome With Oral Baclofen

Phase 3
Terminated
Conditions
Alcohol Withdrawal Syndrome
Interventions
Drug: Placebo
First Posted Date
2014-02-03
Last Posted Date
2018-05-23
Lead Sponsor
Denver Health and Hospital Authority
Target Recruit Count
102
Registration Number
NCT02052440
Locations
🇺🇸

Denver Health Hospital, Denver, Colorado, United States

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