Trial · NCT00730522
Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence
NCT00730522, Phase 2, Terminated, Catalyst Pharmaceuticals, Inc.; results first posted 2020-12-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence. Trials, record NCT00730522. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00730522
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence
- NCT number
- NCT00730522
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- Catalyst Pharmaceuticals, Inc.
- Conditions
- Methamphetamine Dependence
- Interventions
- CPP-109 vigabatrin, Matching Placebo
- First posted
- 2008-08-08
- Last updated
- 2020-12-09
- Results first posted
- 2020-12-09
- Limitations and caveats
Study terminated early due to other failed indication for product and only limited data collected without complete analysis. CPP-109 stopped all development in substance dependent indications. Therefore, not able to summarize most data, as not available.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Proportion of Subjects in Each Treatment Group Who Are Amphetamine Abstinent During the Last 2 Weeks of the Treatment Phase (Weeks 11 and 12). | Weeks 11-12 | |
| Secondary | • Number of Methamphetamine Negative Urines During the Treatment Phase • Number of Methamphetamine Use Weeks During the Treatment Phase. | Weeks 1-12 |
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 | The Proportion of Subjects in Each Treatment Group Who Are Amphetamine Abstinent During the Last 2 Weeks of the Treatment Phase (Weeks 11 and 12). | Weeks 11-12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | • Number of Methamphetamine Negative Urines During the Treatment Phase • Number of Methamphetamine Use Weeks During the Treatment Phase. | Weeks 1-12 | Data were not collected due to early study termination. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Proportion of Subjects in Each Treatment Group Who Are Amphetamine Abstinent During the Last 2 Weeks of the Treatment Phase (Weeks 11 and 12). | Vigabatrin | 4 | Participants | ||
| The Proportion of Subjects in Each Treatment Group Who Are Amphetamine Abstinent During the Last 2 Weeks of the Treatment Phase (Weeks 11 and 12). | Placebo | 2 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vigabatrin Tablets | 28 | |
| Overall Study | STARTED | Matching Placebo Tablets | 27 | |
| Overall Study | COMPLETED | Vigabatrin Tablets | 28 | |
| Overall Study | COMPLETED | Matching Placebo Tablets | 27 | |
| Overall Study | NOT COMPLETED | Vigabatrin Tablets | 0 | |
| Overall Study | NOT COMPLETED | Matching Placebo Tablets | 0 |
Source ClinicalTrials.gov
Adverse events66
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 | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Vigabatrin | 0 | 28 | |
| other | Fatigue | General disorders | Placebo | 1 | 27 | |
| other | Vomiting | Gastrointestinal disorders | Vigabatrin | 0 | 28 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 27 | |
| other | Nasopharyngitis | Infections and infestations | Vigabatrin | 2 | 28 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 1 | 27 | |
| other | Dizziness | Nervous system disorders | Vigabatrin | 1 | 28 | |
| other | Dizziness | Nervous system disorders | Placebo | 2 | 27 | |
| other | Depression | Psychiatric disorders | Vigabatrin | 0 | 28 | |
| other | Depression | Psychiatric disorders | Placebo | 2 | 27 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vigabatrin | 0 | 28 |
| Total, all-cause mortality | Placebo | 0 | 27 |
| Total, other adverse events | Vigabatrin | 24 | 28 |
| Total, other adverse events | Placebo | 23 | 27 |
| Total, serious adverse events | Vigabatrin | 2 | 28 |
| Total, serious adverse events | Placebo | 0 | 27 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vigabatrin vs Placebo: The Proportion of Subjects in Each Treatment Group Who Are Amphetamine Abstinent During the Last 2 Weeks of the Treatment Phase (Weeks 11 and 12). | Trial comparisons |
| Vigabatrin vs Placebo: deaths from any cause | Trial comparisons |
| Vigabatrin 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.
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/NCT00730522
GET https://conductscience.org/api/trials/v1/NCT00730522/events?page=2