Comparison of a Drug and Placebo in the Prevention of Migraine Headaches
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ClinicalTrials.gov Identifier: NCT01122381 |
Recruitment Status :
Terminated
(poor recruitment)
First Posted : May 13, 2010
Results First Posted : August 19, 2015
Last Update Posted : August 19, 2015
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
Condition |
Headache, Migraine |
Interventions |
Drug: ethosuximide Other: placebo comparator |
Enrollment | 5 |
Recruitment Details |
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 | 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. |
Arm/Group Title | Arm 1-drug Treatment | Arm 2-placebo |
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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 |
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 |
Period Title: Overall Study | ||
Started | 1 | 1 |
Completed | 1 [1] | 0 |
Not Completed | 0 | 1 |
Reason Not Completed | ||
study terminated early | 0 | 1 |
[1]
Subject never took the drug per review of ESX levels after unblinding
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Arm/Group Title | Arm 1 | Arm 2 | Total | |
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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 |
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 of all reporting groups | |
Overall Number of Baseline Participants | 1 | 1 | 2 | |
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Enrollees who completed baseline period and randomization.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1 participants | 1 participants | 2 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
1 100.0%
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1 100.0%
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2 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1 participants | 1 participants | 2 participants | |
Female |
1 100.0%
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0 0.0%
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1 50.0%
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Male |
0 0.0%
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1 100.0%
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1 50.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1 participants | 1 participants | 2 participants | |
Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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Not Hispanic or Latino |
1 100.0%
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1 100.0%
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2 100.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1 participants | 1 participants | 2 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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White |
1 100.0%
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1 100.0%
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2 100.0%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 1 participants | 1 participants | 2 participants |
1 | 1 | 2 |
Name/Title: | Kathy Gardner MD |
Organization: | Vetarans Administration Pittsburgh Healthcare System |
Phone: | (412) 360-6185 |
EMail: | kathy.gardner@va.gov |
Responsible Party: | VA Office of Research and Development ( US Department of Veterans Affairs ) |
ClinicalTrials.gov Identifier: | NCT01122381 |
Other Study ID Numbers: |
B5043-R |
First Submitted: | May 10, 2010 |
First Posted: | May 13, 2010 |
Results First Submitted: | June 5, 2015 |
Results First Posted: | August 19, 2015 |
Last Update Posted: | August 19, 2015 |