Acetyl-L-Carnitine In Severe Hepatic Encephalopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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 Phase
Hepatic Encephalopathy (Grade 3 of the West Haven Grading Scale) Drug: Acetyl-l-Carnitine Drug: placebo Not Applicable

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

Resource links provided by the National Library of Medicine

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older 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 identifier (NCT number): NCT01223768

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