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NCT01504295 · ClinicalTrials.gov registry record · Phase 2

A Novel Pharmacotherapy for Alcoholism and Alcohol Liver Disease

A Phase 2 study of Alcoholism and Alcoholic Liver Disease, sponsored by Brown University.

Completed
Registry status
Phase 2
Development phase
38
Enrollment target
1
Study location

NCT01504295 is a Phase 2 study of Alcoholism and Alcoholic Liver Disease that has completed, run by Brown University. The registered enrollment target is 38 participants, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01504295, a Phase 2 study of Alcoholism and Alcoholic Liver Disease, has completed, sponsored by Brown University.

COMPLETED
Registry status
Phase 2
Development phase
38 participants
Enrollment target
1
Study location

Study Summary

It is proposed to test metadoxine (MTDX) that it is hypothesized to be significantly beneficial for the treatment of alcoholism and ALD. Metadoxine is currently approved in Europe for acute and chronic alcohol intoxication but has never been tested in the US. Furthermore, MTDX is used in Europe to treat ALD. Preliminary evidence shows that MTDX reduces alcohol consumption in AD individuals. If the role of MTDX in reducing alcohol consumption and improve liver function is confirmed by a rigorous study design, then MTDX might represent a truly innovative pharmacotherapy for AD, given the potential to be used for AD individuals with ALD. However until this proposal, MTDX has never been investigated as a treatment for AD able to reduce both alcohol consumption and improve alcohol-related liver damage via a double-blind placebo-controlled study. This project therefore proposes to conduct a 12-week (followed by a 3-month follow-up), double-blind, placebo-controlled, between-subject randomized clinical trial with MTDX (500mg t.i.d.) in AD individuals.

Conditions Studied

Alcoholism Alcoholic Liver Disease

Interventions

  • DRUG Metadoxine

Study Locations (1)

Rhode Island

  • Brown University Center for Alcohol and Addiction Studies - Providence

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2012-04
Est. Completion 2015-02
Phase Phase 2

Sponsor

Brown University

231 total trials

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What the Registry Record Tells You About NCT01504295

The ClinicalTrials.gov registry entry for NCT01504295 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (90% lower). The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Alcoholism appearing as the primary indexed condition, and to 1 intervention - of which Metadoxine is the first listed.

NCT01504295 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.

Frequently Asked Questions

What is clinical trial NCT01504295 about?

NCT01504295 is a clinical study titled "A Novel Pharmacotherapy for Alcoholism and Alcohol Liver Disease". It is proposed to test metadoxine (MTDX) that it is hypothesized to be significantly beneficial for the treatment of alcoholism and ALD. Metadoxine is currently approved in Europe for acute and chronic alcohol intoxication but has never been tested in the US. Furthermore, MTDX is used in Europe to t...

What is the current status of trial NCT01504295?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2012-04. Estimated completion is 2015-02.

What conditions does trial NCT01504295 study?

This clinical trial studies the following conditions: Alcoholism, Alcoholic Liver Disease.

What interventions are being tested in trial NCT01504295?

The interventions under investigation include: Metadoxine (DRUG).

Who is sponsoring clinical trial NCT01504295?

This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01504295 being conducted?

This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.