Comparison of a Drug and Placebo in the Prevention of Migraine Headaches
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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
| Condition: |
Headache, Migraine |
| Interventions: |
Drug: ethosuximide Other: placebo comparator |
Participant Flow
Hide Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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Primary Care and Neurology Clinic prescreening and recruitment from VA Pittsburgh hospitals during the following periods: 1/14/11-4/1/11; 1/14/12-3/19/12; 2/4/13-3/12/14. Average prescreening of datawarehouse records for eligibility = 2954 subjects/month. Average prescreening electronic chart review for eligibility = 265 subjects/month. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| 5 consented. Initial 4 week baseline period uses headache diary to confirm headache days prior to randomization. 3/5 enrollees did not begin baseline phase; 1 lost to f/u, 1 dis-enrolled due to study interruption, 1 dis-enrolled shortly after consent when another physician began a study excluded drug. 2 enrollees did complete baseline phase. |
Reporting Groups
| Description | |
|---|---|
| Arm 1-drug Treatment |
migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria ethosuximide: ethosuximide (ESX) 250mg blinded capsules; begin 250mg qd titrating up to 1000mg qd (expected) or 1250mg qd, or 1500mg qd /30mg/kg/d maximum for efficacy goal of < 50% reduction in headache days versus maximum tolerability |
| Arm 2-placebo |
migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria placebo comparator: placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability |
Participant Flow: Overall Study
| Arm 1-drug Treatment | Arm 2-placebo | |
|---|---|---|
| STARTED | 1 | 1 |
| COMPLETED | 1 [1] | 0 |
| NOT COMPLETED | 0 | 1 |
| study terminated early | 0 | 1 |
| [1] | Subject never took the drug per review of ESX levels after unblinding |
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Baseline Characteristics
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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| Enrollees who completed baseline period and randomization. |
Reporting Groups
| Description | |
|---|---|
| Arm 1 |
migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria ethosuximide: ethosuximide (ESX) 250mg blinded capsules; begin 250mg qd titrating up to 1000mg qd (expected) or 1250mg qd, or 1500mg qd /30mg/kg/d maximum for efficacy goal of < 50% reduction in headache days versus maximum tolerability |
| Arm 2 |
placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed "30mg"/kg/d) vs maximum tolerability placebo comparator: placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability |
| Total | Total of all reporting groups |
Baseline Measures
| Arm 1 | Arm 2 | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
1 | 1 | 2 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 0 | 0 | 0 |
|
Gender
[units: participants] |
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| Female | 1 | 0 | 1 |
| Male | 0 | 1 | 1 |
|
Ethnicity (NIH/OMB)
[units: participants] |
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| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
|
Race (NIH/OMB)
[units: participants] |
|||
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
|
Region of Enrollment
[units: participants] |
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| United States | 1 | 1 | 2 |
Outcome Measures
Show Outcome Measure 1
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| 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. |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Results Point of Contact:
Organization: Vetarans Administration Pittsburgh Healthcare System
phone: (412) 360-6185
e-mail: kathy.gardner@va.gov
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT01122381 History of Changes |
| Other Study ID Numbers: |
B5043-R |
| Study First Received: | May 10, 2010 |
| Results First Received: | June 5, 2015 |
| Last Updated: | August 11, 2015 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |