Trial · NCT01281202

Vigabatrin for the Treatment of Cocaine Dependency

NCT01281202, Phase 2, Phase 3, Completed, Catalyst Pharmaceuticals, Inc.; results first posted 2016-02-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vigabatrin for the Treatment of Cocaine Dependency. Trials, record NCT01281202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01281202

On this page

Trial

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

Title: Vigabatrin for the Treatment of Cocaine Dependency
NCT number: NCT01281202
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 207 participants, actual
Lead sponsor: Catalyst Pharmaceuticals, Inc.
Conditions: Cocaine Addiction, Cocaine Dependence
Interventions: Vigabatrin, Matching Placebo
First posted: 2011-01-21
Last updated: 2016-05-18
Results first posted: 2016-02-23

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Abstinence	Weeks 8-9	The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9).
Secondary	Number of Participants With Cocaine Use	Week 3 - 9

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	Abstinence	Weeks 8-9		participants	NUMBER
SECONDARY	Number of Participants With Cocaine Use	Week 3 - 9		participants	NUMBER

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Category	Value	Units
Abstinence	CPP-109 Vigabatrin Tablets		5	participants
Abstinence	Matching Placebo		9	participants
Number of Participants With Cocaine Use	CPP-109 Vigabatrin Tablets	Week 3	95	participants
Number of Participants With Cocaine Use	Placebo	Week 3	96	participants
Number of Participants With Cocaine Use	CPP-109 Vigabatrin Tablets	Week 4	91	participants
Number of Participants With Cocaine Use	Placebo	Week 4	95	participants
Number of Participants With Cocaine Use	CPP-109 Vigabatrin Tablets	Week 5	88	participants
Number of Participants With Cocaine Use	Placebo	Week 5	93	participants
Number of Participants With Cocaine Use	CPP-109 Vigabatrin Tablets	Week 6	86	participants
Number of Participants With Cocaine Use	Placebo	Week 6	90	participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	CPP-109 Vigabatrin Tablets	103
Overall Study	STARTED	Placebo	104
Overall Study	COMPLETED	CPP-109 Vigabatrin Tablets	75
Overall Study	COMPLETED	Placebo	68
Overall Study	NOT COMPLETED	CPP-109 Vigabatrin Tablets	28
Overall Study	NOT COMPLETED	Placebo	36

Source ClinicalTrials.gov

Adverse events44

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	Nausea	Gastrointestinal disorders	CPP-109 Vigabatrin Tablets	8	103
other	Nausea	Gastrointestinal disorders	Placebo	25	104
other	Headache	Nervous system disorders	CPP-109 Vigabatrin Tablets	22	103
other	Headache	Nervous system disorders	Placebo	29	104
other	Back pain	Musculoskeletal and connective tissue disorders	CPP-109 Vigabatrin Tablets	8	103
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	13	104
other	Pain in extremity	Musculoskeletal and connective tissue disorders	CPP-109 Vigabatrin Tablets	11	103
other	Pain in extremity	Musculoskeletal and connective tissue disorders	Placebo	8	104
other	Fatigue	General disorders	CPP-109 Vigabatrin Tablets	16	103
other	Fatigue	General disorders	Placebo	13	104

1 to 10 of 44Source ClinicalTrials.gov

See all 44 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
Total, all-cause mortality	Placebo
Total, other adverse events	CPP-109 Vigabatrin Tablets	84	103
Total, other adverse events	Placebo	89	104
Total, serious adverse events	CPP-109 Vigabatrin Tablets	6	103
Total, serious adverse events	Placebo	3	104

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 vs Matching Placebo: Abstinence	Trial comparisons
CPP-109 Vigabatrin Tablets vs Placebo: 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/NCT01281202

GET https://conductscience.org/api/trials/v1/NCT01281202/events?page=2

API reference For AI assistants