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COMPLETED Phase 2

Vigabatrin for the Treatment of Cocaine Dependency

NCT01281202 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling.

Interventions

  • DRUG Matching Placebo
  • DRUG Vigabatrin

Study Locations (13)

California

  • Matrix Institute on Addictions — Los Angeles
  • Friends Research Institute — Torrance

Texas

  • Pillar Clinical Research, LLC — Dallas
  • University of Texas Health Science Center at Houston — Houston

Colorado

  • VA Medical Center — Denver

Florida

  • University of Miami School of Medicine — Miami

Illinois

  • NeuroPsychiatric Research & Practice Assoc., Ltd. — Oak Brook

Maryland

  • Mountain Manor Treatment Center @ Baltimore — Baltimore

Massachusetts

  • Boston University School of Medicine — Boston

New Mexico

  • Pacific Institute for Research and Evaluation — Albuquerque

Trial Details

FieldValue
Enrollment Target 207 participants
Start Date 2011-01
Est. Completion 2012-12
Phase Phase 2

Sponsor

Catalyst Pharmaceuticals

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01281202

The ClinicalTrials.gov registry entry for NCT01281202 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 207 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Catalyst Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Cocaine Dependence appearing as the primary indexed condition, and to 2 interventions — of which Matching Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01281202 reports 13 study locations spanning 11 distinct geographic areas — top geographies include California, Texas, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01281202 about?

NCT01281202 is a clinical study titled "Vigabatrin for the Treatment of Cocaine Dependency". The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects t...

What is the current status of trial NCT01281202?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 207 participants. The study started on 2011-01. Estimated completion is 2012-12.

What conditions does trial NCT01281202 study?

This clinical trial studies the following conditions: Cocaine Dependence, Cocaine Addiction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01281202?

The interventions under investigation include: Matching Placebo (DRUG), Vigabatrin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01281202?

This trial is sponsored by Catalyst Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01281202 being conducted?

This trial has 13 study locations across California, Colorado, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial