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

Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen

Phase 4

Terminated

Conditions: Overactive Bladder
Constipation
Lower Urinary Tract Symptoms

Interventions: Drug: Baclofen
Drug: Placebo

First Posted Date: 2009-10-28

Last Posted Date: 2018-08-14

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 12

Registration Number: NCT01003249

Locations: 🇺🇸
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients

Phase 4

Completed

Conditions: Alcohol Dependence

Interventions: Other: Control group
Drug: Baclofen

First Posted Date: 2009-10-27

Last Posted Date: 2017-01-27

Lead Sponsor: Sha'ar Menashe Mental Health Center

Target Recruit Count: 75

Registration Number: NCT01002105

Locations: 🇮🇱
Alexander Grinshpoon, Hadera, Israel

Efficacy and Tolerability of Baclofen for Alcohol Dependence

Phase 2

Completed

Conditions: Alcohol Dependence

Interventions: Drug: baclofen
Drug: placebo
Behavioral: BRENDA counseling

First Posted Date: 2009-04-08

Last Posted Date: 2012-09-14

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 80

Registration Number: NCT00877734

Locations: 🇺🇸
University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, United States

Effect of Low-Dose Baclofen Administration on the GH-IGF1 Axis Study

Not Applicable

Completed

Conditions: Spinal Cord Injury

Interventions: Drug: Baclofen

First Posted Date: 2009-03-30

Last Posted Date: 2012-04-02

Lead Sponsor: US Department of Veterans Affairs

Target Recruit Count: 20

Registration Number: NCT00871455

Locations: 🇺🇸
VA Medical Center, Bronx, Bronx, New York, United States

Comparative Bioavailability Study of Baclofen 20 mg Tablets in Healthy Male Volunteers / Fasting State

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Baclofen

First Posted Date: 2008-04-01

Last Posted Date: 2024-04-24

Lead Sponsor: Mylan Pharmaceuticals Inc

Target Recruit Count: 27

Registration Number: NCT00647738

Locations: 🇨🇦
Algorithme Pharma, Montreal, Quebec, Canada

Baclofen Treatment of Ataxia Telangiectasia

Early Phase 1

Completed

Conditions: Ataxia Telangiectasia

Interventions: Drug: Baclofen
Drug: Placebo

First Posted Date: 2008-03-20

Last Posted Date: 2017-12-20

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 10

Registration Number: NCT00640003

Locations: 🇺🇸
Johns Hopkins Hospital, Baltimore, Maryland, United States

Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity

Phase 1

Completed

Conditions: Spasticity
Cerebral Palsy

Interventions: Drug: baclofen

First Posted Date: 2008-02-05

Last Posted Date: 2011-12-06

Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Target Recruit Count: 61

Registration Number: NCT00607542

Locations: 🇺🇸
Kennedy Krieger Institute, Baltimore, Maryland, United States
🇺🇸
Washington Univeristy - St. Louis Children's hospital, St. Louis, Missouri, United States
🇺🇸
SUNY Upstate Medical University, Syracuse, New York, United States

and more 8 locations

Treating Alcohol Withdrawal With Oral Baclofen

Not Applicable

Completed

Conditions: Alcohol Withdrawal Delirium

Interventions: Drug: Placebo
Drug: Baclofen
Drug: Lorazepam

First Posted Date: 2008-01-18

Last Posted Date: 2011-07-27

Lead Sponsor: Essentia Health

Target Recruit Count: 79

Registration Number: NCT00597701

Locations: 🇺🇸
Essentia Health, Duluth, Minnesota, United States

Efficacy of Baclofen in the Treatment of Alcohol Addiction

Phase 1

Completed

Conditions: Liver Cirrhosis, Alcoholic

Interventions: Drug: placebo
Drug: Baclofen

First Posted Date: 2007-09-05

Last Posted Date: 2007-09-05

Lead Sponsor: Catholic University of the Sacred Heart

Target Recruit Count: 86

Registration Number: NCT00525252

Treatment of Non-Metastatic Hepatocellular Carcinoma in Humans by Increasing Gabaergic Activity: A Pilot Study

Phase 2

Withdrawn

Conditions: Hepatocellular Carcinoma

First Posted Date: 2007-06-28

Last Posted Date: 2014-05-16

Lead Sponsor: University of Manitoba

Registration Number: NCT00493428

Locations: 🇨🇦
Liver Unit, Section of Hepatology, Department of Medicine,Health Sciences Centre, Winnipeg, Manitoba, Canada
🇨🇦
Liver Unit, health sciences Centre, Winnipeg, Manitoba, Canada

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