Trial · NCT01122381
Comparison of a Drug and Placebo in the Prevention of Migraine Headaches
NCT01122381, Phase 1, Phase 2, Terminated, US Department of Veterans Affairs; results first posted 2015-08-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of a Drug and Placebo in the Prevention of Migraine Headaches. Trials, record NCT01122381. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01122381
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of a Drug and Placebo in the Prevention of Migraine Headaches
- NCT number
- NCT01122381
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- US Department of Veterans Affairs
- Conditions
- Headache, Migraine
- Interventions
- ethosuximide, placebo comparator
- First posted
- 2010-05-13
- Last updated
- 2015-08-19
- Results first posted
- 2015-08-19
- Limitations and caveats
- Early termination occurred due to inadequate recruitment of episodic migraineurs in a population meeting too many exclusion criteria; resulting in no subjects available for analysis.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Migraine Headache Days Per 4 Week Period Comparing the Last 4 Weeks of Treatment to a 4 Week Pre-treatment Baseline. | 4 weeks, end of treatment and pre-treatment baseline | Compare number of migraine headache days pre and post treatment between the ESX and placebo group. Study terminated early-no outcome data available. The single subject assigned to study drug did not actually take it according to subsequent review of ESX drug levels. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Migraine Headache Days Per 4 Week Period Comparing the Last 4 Weeks of Treatment to a 4 Week Pre-treatment Baseline. | 4 weeks, end of treatment and pre-treatment baseline |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1-drug Treatment | 1 | |
| Overall Study | STARTED | Arm 2-placebo | 1 | |
| Overall Study | COMPLETED | Arm 1-drug Treatment | 1 | |
| Overall Study | COMPLETED | Arm 2-placebo | 0 | |
| Overall Study | NOT COMPLETED | Arm 1-drug Treatment | 0 | |
| Overall Study | NOT COMPLETED | Arm 2-placebo | 1 |
Source ClinicalTrials.gov
Adverse events12
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 | hiccups | Respiratory, thoracic and mediastinal disorders | Arm 1- Ethosuximide | 1 | 1 | 1 |
| other | hiccups | Respiratory, thoracic and mediastinal disorders | Arm 2- Placebo Comparator | 1 | 1 | 1 |
| other | fatigue | General disorders | Arm 1- Ethosuximide | 1 | 1 | 1 |
| other | fatigue | General disorders | Arm 2- Placebo Comparator | 1 | 1 | 1 |
| other | diarrhea | Gastrointestinal disorders | Arm 1- Ethosuximide | 0 | 1 | 0 |
| other | diarrhea | Gastrointestinal disorders | Arm 2- Placebo Comparator | 1 | 1 | 1 |
| other | abdominal pain | Gastrointestinal disorders | Arm 1- Ethosuximide | 1 | 1 | 1 |
| other | abdominal pain | Gastrointestinal disorders | Arm 2- Placebo Comparator | 0 | 1 | 0 |
| other | somnolence | Nervous system disorders | Arm 1- Ethosuximide | 1 | 1 | 1 |
| other | somnolence | Nervous system disorders | Arm 2- Placebo Comparator | 0 | 1 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1- Ethosuximide | ||
| Total, all-cause mortality | Arm 2- Placebo Comparator | ||
| Total, other adverse events | Arm 1- Ethosuximide | 1 | 1 |
| Total, other adverse events | Arm 2- Placebo Comparator | 1 | 1 |
| Total, serious adverse events | Arm 1- Ethosuximide | 0 | 1 |
| Total, serious adverse events | Arm 2- Placebo Comparator | 0 | 1 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm 1- Ethosuximide vs Arm 2- Placebo Comparator: serious adverse events |
Source 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/NCT01122381
GET https://conductscience.org/api/trials/v1/NCT01122381/registered