We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of a Drug and Placebo in the Prevention of Migraine Headaches

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Thomas Jefferson University
University of Pittsburgh
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
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
Hide Arm/Group Description

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
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
Enrollees who completed baseline period and randomization.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
2
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
1
 100.0%
0
   0.0%
1
  50.0%
Male
0
   0.0%
1
 100.0%
1
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
1
 100.0%
1
 100.0%
2
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
1
 100.0%
1
 100.0%
2
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants
1 1 2
1.Primary Outcome
Title Migraine Headache Days Per 4 Week Period Comparing the Last 4 Weeks of Treatment to a 4 Week Pre-treatment Baseline.
Hide Description

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.

Time Frame 4 weeks, end of treatment and pre-treatment baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1-ethosuximide Arm 2-placebo Comparator
Hide Arm/Group Description:
Study was terminated early-no outcome data available. Only one subject was assigned to study drug arm but did not actually take it according to subsequent review of ESX drug levels.
Study was terminated early-no outcome data available. Only one subject was assigned to study placebo but was dis-enrolled after titration phase due to study termination.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1- Ethosuximide Arm 2- Placebo Comparator
Hide Arm/Group Description ethosuximide blinded capsules of 250mg ESX; subject was titrated up to 4 capsules qd placebo blinded capsules of "250mg"; subject was titrated up to 4 capsules qd
All-Cause Mortality
Arm 1- Ethosuximide Arm 2- Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Arm 1- Ethosuximide Arm 2- Placebo Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/1 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1- Ethosuximide Arm 2- Placebo Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      1/1 (100.00%)    
Gastrointestinal disorders     
diarrhea  1 [1]  0/1 (0.00%)  0 1/1 (100.00%)  1
abdominal pain  1 [1]  1/1 (100.00%)  1 0/1 (0.00%)  0
nausea  1 [1]  0/1 (0.00%)  0 1/1 (100.00%)  1
General disorders     
fatigue  1 [1]  1/1 (100.00%)  1 1/1 (100.00%)  1
Nervous system disorders     
somnolence  1 [1]  1/1 (100.00%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
hiccups  1 [1]  1/1 (100.00%)  1 1/1 (100.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
grade 1, mild
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.
Certain Agreements
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
Layout table for Results Point of Contact information
Name/Title: Kathy Gardner MD
Organization: Vetarans Administration Pittsburgh Healthcare System
Phone: (412) 360-6185
EMail: kathy.gardner@va.gov
Layout table for additonal information
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