Trial Outcomes & Findings for A Clinical Study Examining the Safety and Effectiveness of a New Medication (Keppra®) for the Prevention of Migraine Headaches (NCT NCT00203216)

Results Overview

Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals: * visit\_4 = first follow-up interval (0 to 28 days after starting study drug) * visit\_5 = second follow-up interval (28 to 56 days) * visit\_6 = third follow-up interval (56 to 84 days) * visit\_7 = fourth follow-up interval (84 to 126 days) The change in headache attacks post-treatment will be averaged in a multiple regression model, looking at the following: visit number, age, gender, BMI

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

Compare frequency of migraine attacks in baseline period to the average of the change following these 28 day periods prior to: Visit 4 (day 0-28), visit 5 (day 28-56), visit 6 (day 576-84), visit 7 (day 84-126).

Results posted on

2011-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	Levetiracetam/Transcranial Magnetic Stimulation In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
Overall Study STARTED	31
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Study Examining the Safety and Effectiveness of a New Medication (Keppra®) for the Prevention of Migraine Headaches

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levetiracetam/Transcranial Magnetic Stimulation n=31 Participants In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	39 years STANDARD_DEVIATION 12.47 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: Compare frequency of migraine attacks in baseline period to the average of the change following these 28 day periods prior to: Visit 4 (day 0-28), visit 5 (day 28-56), visit 6 (day 576-84), visit 7 (day 84-126).

Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals: * visit\_4 = first follow-up interval (0 to 28 days after starting study drug) * visit\_5 = second follow-up interval (28 to 56 days) * visit\_6 = third follow-up interval (56 to 84 days) * visit\_7 = fourth follow-up interval (84 to 126 days) The change in headache attacks post-treatment will be averaged in a multiple regression model, looking at the following: visit number, age, gender, BMI

Outcome measures

Outcome measures
Measure	Levetiracetam/Transcranial Magnetic Stimulation n=31 Participants In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
The Primary Outcome is Defined as Average Change in Frequency of Migraine Attacks Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.	-0.058 migraine attacks per month Standard Deviation 5.10

SECONDARY outcome

Timeframe: Baseline period (day -28 to day 0) compared to the 28 day period prior to Visit 4-7.

Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals: * visit\_4 = first follow-up interval (0 to 28 days after starting study drug) * visit\_5 = second follow-up interval (28 to 56 days) * visit\_6 = third follow-up interval (56 to 84 days) * visit\_7 = fourth follow-up interval (84 to 126 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline period compared to 28 day interval prior to Visit 4-7.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline period compared to the 28 day period prior to each of the following visits: Visit 4-7.

Outcome measures

Outcome data not reported

Adverse Events

Levetiracetam/Transcranial Magnetic Stimulation

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Levetiracetam/Transcranial Magnetic Stimulation n=31 participants at risk In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
Nervous system disorders fatigue	67.7% 21/31 • Number of events 21
Nervous system disorders Irritability	51.6% 16/31 • Number of events 16
Nervous system disorders Dizziness	41.9% 13/31 • Number of events 13
Psychiatric disorders Labile mood	19.4% 6/31 • Number of events 6

Additional Information

Dr. William Young, Principal Investigator

Thomas Jefferson University/Jefferson Headache Center

Phone: 215-955-2243

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place