NCT01223768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed
Last Updated

October 19, 2010

Status Verified

December 1, 2000

First QC Date

October 18, 2010

Last Update Submit

October 18, 2010

Conditions

Hepatic Encephalopathy (Grade 3 of the West Haven Grading Scale)

Study Arms (2)

Acetyl-L-carnitine

EXPERIMENTAL
Drug: Acetyl-l-Carnitine

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

Acetyl-l-CarnitineDRUG

2g per day

Acetyl-L-carnitine
placeboDRUG

twice per day

placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with a history of recent alcohol abuse, patients using psychotropic drugs (e.g., antipsychotics, interferon, benzodiazepines, anti-epileptics, sedatives and antidepressants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cannizzaro Hospital

Catania, 95126, Italy

Location

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Acetylcarnitine

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CarnitineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 19, 2010

Study Start

July 1, 2002

Study Completion

December 1, 2005

Last Updated

October 19, 2010

Record last verified: 2000-12

Locations

IT(1)