Baclofen

Generic Name: Baclofen

Brand Names: Fleqsuvy, Gablofen, Kemstro, Lioresal, Lyvispah, Ozobax

Drug Type: Small Molecule

Chemical Formula: C_₁₀H_₁₂ClNO_₂

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 FD...

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...

Associated Conditions: Alcohol Dependency, Severe Spasticity, Spasticity, Flexor spasm, Severe cerebral origin Spasticity, Severe spinal cord origin Spasticity

Associated Therapies: -

Clinical Trials

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: Drug: Metaxalone
Drug: Tizanidine
Drug: Baclofen
Drug: Ibuprofen 600 mg
Behavioral: Educational intervention

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: Drug: Opipramol
Drug: Baclofen

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: Drug: Acamprosate
Drug: Lovastatin
Drug: Minocycline
Drug: Placebo
Drug: Baclofen

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: Drug: Baclofen

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 baclofen
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

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: Drug: Baclofen

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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