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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

Safety & Efficacy of Baclofen for Alcohol Withdrawal in Chronic Liver Disease With Active Alcohol Consumption

Conditions
Alcoholic Cirrhosis
Alcohol Abstinence
Alcohol Withdrawal
Medication Toxicity
Medication Adherence
Interventions
First Posted Date
2025-02-21
Last Posted Date
2025-02-21
Lead Sponsor
Corporacion Parc Tauli
Target Recruit Count
120
Registration Number
NCT06840652
Locations
🇪🇸

Consorci Corporació Sanitària Parc Taulí, Sabadell, Barcelona, Spain

Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury

Phase 4
Not yet recruiting
Conditions
Traumatic Spinal Cord Injury
Interventions
Drug: Usual routine care
First Posted Date
2024-08-21
Last Posted Date
2024-08-21
Lead Sponsor
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Target Recruit Count
55
Registration Number
NCT06564714
Locations
🇨🇦

CIUSSS du Nord-de-l'île-de-Montréal-Hôpital du Sacré-Cœur de Montréal, Montréal, Quebec, Canada

Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence.

Not Applicable
Not yet recruiting
Conditions
Alcohol Liver Disease
Interventions
First Posted Date
2023-12-19
Last Posted Date
2023-12-19
Lead Sponsor
Institute of Liver and Biliary Sciences, India
Target Recruit Count
110
Registration Number
NCT06175507
Locations
🇮🇳

Institute of Liver & Biliary Sciences (ILBS), New Delhi, Delhi, India

Baclofen for Children With Rumination Syndrome

Phase 3
Recruiting
Conditions
Rumination Syndrome
Interventions
Drug: Placebo
First Posted Date
2023-08-04
Last Posted Date
2024-07-26
Lead Sponsor
Nationwide Children's Hospital
Target Recruit Count
50
Registration Number
NCT05975684
Locations
🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence

Phase 2
Not yet recruiting
Conditions
Benzodiazepine Dependence
Interventions
First Posted Date
2023-07-07
Last Posted Date
2023-10-30
Lead Sponsor
Hospices Civils de Lyon
Target Recruit Count
93
Registration Number
NCT05935553
Locations
🇫🇷

Hôpital Edouard Herriot, Lyon, France

🇫🇷

Centre Hospitalier le Vinatier, Bron, France

Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve Gastrectomy

Phase 3
Active, not recruiting
Conditions
Post Operative Pain
Interventions
First Posted Date
2023-06-27
Last Posted Date
2025-04-24
Lead Sponsor
Tanta University
Target Recruit Count
100
Registration Number
NCT05921604
Locations
🇪🇬

Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt, Tanta, Gharbiya, Egypt

Effect of Baclofen to Prevent Post-Traumatic Stress Disorder

Completed
Conditions
Post Traumatic Stress Disorder
Alcoholism
Interventions
Other: Placebo
First Posted Date
2023-05-26
Last Posted Date
2024-06-17
Lead Sponsor
Nantes University Hospital
Target Recruit Count
94
Registration Number
NCT05877807
Locations
🇫🇷

Montpellier University Hospital, Montpellier, Hérault, France

🇫🇷

Nantes University Hospital, Nantes, Loire-Atlantique, France

🇫🇷

Angers University Hospital, Angers, Maine-et-Loire, France

and more 10 locations

Predictive Factors for Succes of ITB in CP

Not yet recruiting
Conditions
Intrathecal Baclofen
Cerebral Palsy
First Posted Date
2023-04-18
Last Posted Date
2023-04-18
Lead Sponsor
Amsterdam UMC, location VUmc
Target Recruit Count
75
Registration Number
NCT05817409

BTA vs Baclofen for Pelvic Myofascial Pain Syndrome

Recruiting
Conditions
Chronic Pain
Chronic Pelvic Pain Syndrome
Myofascial Pain Syndrome
Myofascial Trigger Point Pain
Pelvic Floor Disorders
Interventions
First Posted Date
2022-11-15
Last Posted Date
2023-04-11
Lead Sponsor
Saint Petersburg State University, Russia
Target Recruit Count
52
Registration Number
NCT05617118
Locations
🇷🇺

SBPSU, Saint Petersburg, Russian Federation

Baclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery

Phase 2
Completed
Conditions
Laparoscopic Sleeve Gastrectomy
Postoperative Nausea and Vomiting
Morbid Obesity
Interventions
First Posted Date
2022-08-26
Last Posted Date
2025-04-22
Lead Sponsor
Tanta University
Target Recruit Count
100
Registration Number
NCT05516953
Locations
🇪🇬

Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital., Tanta, Egypt

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