Trial Outcomes & Findings for Comparison of a Drug and Placebo in the Prevention of Migraine Headaches (NCT NCT01122381)

Last Updated: 2015-08-19

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

4 weeks, end of treatment and pre-treatment baseline

Results posted on

2015-08-19

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	1	1
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study study terminated early	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 4 weeks, end of treatment and pre-treatment baseline

Outcome measures

Outcome data not reported

Adverse Events

Arm 1- Ethosuximide

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm 2- Placebo Comparator

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm 1- Ethosuximide n=1 participants at risk ethosuximide blinded capsules of 250mg ESX; subject was titrated up to 4 capsules qd	Arm 2- Placebo Comparator n=1 participants at risk placebo blinded capsules of "250mg"; subject was titrated up to 4 capsules qd
Respiratory, thoracic and mediastinal disorders hiccups	100.0% 1/1 • Number of events 1 • 16 weeks	100.0% 1/1 • Number of events 1 • 16 weeks
General disorders fatigue	100.0% 1/1 • Number of events 1 • 16 weeks	100.0% 1/1 • Number of events 1 • 16 weeks
Gastrointestinal disorders diarrhea	0.00% 0/1 • 16 weeks	100.0% 1/1 • Number of events 1 • 16 weeks
Gastrointestinal disorders abdominal pain	100.0% 1/1 • Number of events 1 • 16 weeks	0.00% 0/1 • 16 weeks
Nervous system disorders somnolence	100.0% 1/1 • Number of events 1 • 16 weeks	0.00% 0/1 • 16 weeks
Gastrointestinal disorders nausea	0.00% 0/1 • 16 weeks	100.0% 1/1 • Number of events 1 • 16 weeks

Additional Information

Kathy Gardner MD

Vetarans Administration Pittsburgh Healthcare System

Phone: (412) 360-6185

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm 1 n=1 Participants 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 n=1 Participants 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 n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants