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Acetyl-L-Carnitine In Severe Hepatic Encephalopathy

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ClinicalTrials.gov Identifier: NCT01223768
Recruitment Status : Completed
First Posted : October 19, 2010
Last Update Posted : October 19, 2010
Information provided by:
University of Catania

Brief Summary:
To assess the clinical efficacy of ALC in the treatment of severe hepatic encephalopathy (grade 3 of the West Haven grading scale), we performed a randomised, double blind placebo-controlled study administering ALC to cirrhotic patients, evaluating the effects on ammonia levels and performance in cognitive functions.

Condition or disease Intervention/treatment
Hepatic Encephalopathy (Grade 3 of the West Haven Grading Scale) Drug: Acetyl-l-Carnitine Drug: placebo

Study Type : Interventional  (Clinical Trial)
Study Start Date : July 2002
Estimated Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Acetyl-L-carnitine Drug: Acetyl-l-Carnitine
2g per day
Placebo Comparator: placebo Drug: placebo
twice per day

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • patients with severe hepatic encephalopathy (grade 3 of the West Haven grading scale) with hepatic cirrhosis

Exclusion Criteria:

  • Patients with a history of recent alcohol abuse, patients using psychotropic drugs (e.g., antipsychotics, interferon, benzodiazepines, anti-epileptics, sedatives and antidepressants)
  • Other exclusion criteria were the following: major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis; acute superimposed liver injury;patients with metabolic disorders such as diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease; any additional precipitating factors such as high protein intake (additional high-protein meals), constipation; illiteracy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223768

Cannizzaro Hospital
Catania, Italy, 95126
Sponsors and Collaborators
University of Catania

ClinicalTrials.gov Identifier: NCT01223768     History of Changes
Other Study ID Numbers: 8-12-00 C
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: October 19, 2010
Last Verified: December 2000

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Nootropic Agents