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Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence

NCT00730522 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2020-12-09

Study results available
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Summary

The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be methamphetamine-free in the last 2 weeks of the study's Treatment Phase (Weeks 11 and 12).

Conditions

  • Methamphetamine Dependence

Interventions

DRUG

CPP-109 vigabatrin

tablets, bid for 12 weeks

DRUG

Matching Placebo

tablets, bid, 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Charles W Gorodetzky, MD, PhD · Catalyst Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-06-30
Completion
2009-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00730522 on ClinicalTrials.gov