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NCT00862563 · ClinicalTrials.gov registry record · Phase 2
Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism
A Phase 2 study, sponsored by Boston Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
NCT00862563: Clinical Trial Phase 2 study, sponsored by Boston Medical Center.
NCT00862563 is a Phase 2 study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 85 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00862563, a Phase 2 study, was terminated before completion, sponsored by Boston Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
Study Summary
This is a double-blind, placebo-controlled, parallel group design study with 4 treatment groups; levetiracetam, zonisamide, topiramate, and placebo control. Subjects will receive study medications for 14 weeks. Potential subjects will be initially screened for interest in study participation and alcohol consumption level to determine basic eligibility by telephone, or in person. Individuals who meet telephone screening criteria will be scheduled for a clinic appointment to obtain informed consent and conduct screening assessments. Subjects who report average drinks per day that are within the guidelines for safe levels of alcohol consumption (i.e. 2 drinks/ day males; 1 drink/day females-HHS standard) in the two weeks prior to screening will be excluded. Subjects meeting screening criteria will be scheduled for a second randomization visit. During this visit baseline assessments will be obtained. Eligible subjects will then be randomized to a treatment group and will be provided with the first week's study medications. The goal is to directly compare the efficacy and tolerability of two novel anticonvulsants, zonisamide and levetiracetam, with placebo, and using topiramate, which has extensive evidence supporting its efficacy in alcoholism, as a positive control group. We believe that this will be the first direct comparison of these agents in alcoholism, and the results will provide information on the efficacy and safety of the medications.
Primary Outcome
Mean standard drinks consumed per day for each treatment week, weeks 10 thru 12. Actual mean values obtained are shown. Analyses are based on model generated least squares means for a two -way repeated measures mixed models analysis for data obtained for weeks 1 through 12, with baseline values used as covariates. Week (time) was used as the within subject factor and treatment group was the between group factor.
Interventions
- DRUG Levetiracetam
- DRUG Topiramate
- DRUG Zonisamide
- DRUG Sugar Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2009-05 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
Why NCT00862563 stopped before completion
NCT00862563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 4 interventions - of which Levetiracetam is the first listed.
NCT00862563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00862563 about?
NCT00862563 is a clinical study titled "Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism". This is a double-blind, placebo-controlled, parallel group design study with 4 treatment groups; levetiracetam, zonisamide, topiramate, and placebo control. Subjects will receive study medications for 14 weeks. Potential subjects will be initially screened for interest in study participation and alc...
What is the current status of trial NCT00862563?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2009-05. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00862563?
The interventions under investigation include: Levetiracetam (DRUG), Topiramate (DRUG), Zonisamide (DRUG), Sugar Pill (DRUG).
Who is sponsoring clinical trial NCT00862563?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00862563's enrollment target sits among peer trials
85 820th of 2000 higher than 1,179 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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