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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: Completed Phase 2 study of Alcoholism and Alcoholic Liver Disease, sponsored by Brown University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
We hypothesize that metadoxine (MTDX), compared to placebo significantly increases percent days abstinent (PDA) during the 12 weeks of drug administration, as measured by the timeline follow-back (TLFB).
Conditions Studied
Interventions
- DRUG Metadoxine
Study Locations (1)
Rhode Island
- Brown University Center for Alcohol and Addiction Studies - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-02 |
| Phase | Phase 2 |
What the finished NCT01504295 record still lists
NCT01504295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01504295's enrollment target sits among peer trials
38 59th of 65 higher than 7 of 65 other Alcoholism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcoholism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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