Trial · NCT00611130

Vigabatrin for Treatment of Cocaine Dependence

NCT00611130, Phase 2, Completed, Catalyst Pharmaceuticals, Inc.; results first posted 2012-06-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vigabatrin for Treatment of Cocaine Dependence. Trials, record NCT00611130. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00611130

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vigabatrin for Treatment of Cocaine Dependence
NCT number: NCT00611130
Status: Completed
Phases: Phase 2
Enrollment: 186 participants, actual
Lead sponsor: Catalyst Pharmaceuticals, Inc.
Conditions: Cocaine Dependence
Interventions: vigabatrin, placebo
First posted: 2008-02-08
Last updated: 2016-04-13
Results first posted: 2012-06-12
Limitations and caveats: Lack of subject medication compliance, site-to-site variability in medication compliance possibly indicative of differing site capabilities to attract subjects sufficiently motivated to stop using cocaine.

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.	Week 13	Number of subjects in the CPP-109 Vigabatrin Group vs. Number in Placebo Group abstinent from using cocaine during Weeks 11 and 12 of the Treatment Phase.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.	Week 13	intent-to-treat	participants	NUMBER
POST_HOC	Medication Compliance	Week 2, 4, 6 & 9-11	Completers were defined as those who attended the scheduled Week 13 visit or the third visit of Week 12 and who also had provided urines during Weeks 11 \& 12.	participants	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.	CPP-109 Vigabatrin Tablets, 500 mg		7	participants
Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.	Matching Placebo Tablets		5	participants
Medication Compliance	Treatment Phase Completers	Number of Vigabatrin Completers Analyzed	61	participants
Medication Compliance	Treatment Phase Completers	Number Medication Compliant	24	participants

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	CPP-109 Vigabatrin	92
Overall Study	STARTED	Placebo	94
Overall Study	Completed 12 Week Treatment Phase	CPP-109 Vigabatrin	61
Overall Study	Completed 12 Week Treatment Phase	Placebo	64
Overall Study	COMPLETED	CPP-109 Vigabatrin	43
Overall Study	COMPLETED	Placebo	47
Overall Study	NOT COMPLETED	CPP-109 Vigabatrin	49
Overall Study	NOT COMPLETED	Placebo	47

Source ClinicalTrials.gov

Adverse events54

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Photopsia	Eye disorders	CPP-109 Vigabatrin Tablets, 500 mg	8	92
other	Photopsia	Eye disorders	Matching Placebo Tablet	1	94
other	Blurred vision	Eye disorders	CPP-109 Vigabatrin Tablets, 500 mg	6	92
other	Blurred vision	Eye disorders	Matching Placebo Tablet	6	94
other	Visual disturbance	Eye disorders	CPP-109 Vigabatrin Tablets, 500 mg	6	92
other	Visual disturbance	Eye disorders	Matching Placebo Tablet	3	94
other	Constipation	Gastrointestinal disorders	CPP-109 Vigabatrin Tablets, 500 mg	5	92
other	Constipation	Gastrointestinal disorders	Matching Placebo Tablet	5	94
other	Diarrhea	Gastrointestinal disorders	CPP-109 Vigabatrin Tablets, 500 mg	14	92
other	Diarrhea	Gastrointestinal disorders	Matching Placebo Tablet	15	94

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CPP-109 Vigabatrin Tablets, 500 mg
Total, all-cause mortality	Matching Placebo Tablet
Total, other adverse events	CPP-109 Vigabatrin Tablets, 500 mg	73	92
Total, other adverse events	Matching Placebo Tablet	81	94
Total, serious adverse events	CPP-109 Vigabatrin Tablets, 500 mg	6	92
Total, serious adverse events	Matching Placebo Tablet	0	94

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22704138	DERIVED	PubMed
23575810	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
CPP-109 Vigabatrin Tablets, 500 mg vs Matching Placebo Tablets: Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.	Trial comparisons
CPP-109 Vigabatrin Tablets, 500 mg vs Matching Placebo Tablet: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00611130

GET https://conductscience.org/api/trials/v1/NCT00611130/events?page=2

API reference For AI assistants