Trial Outcomes & Findings for A Research Study Examining the Use of Olanzapine for the Prevention of Migraine (NCT NCT00203307)

Results Overview

Definition of migraine headache period: One migraine period is defined as a 24-hour period starting at the time of onset of the migraine headache, during which the migraine headache is present\*. Definition of time frames: First treatment period: Day 1 to 84. Second treatment period: day 113-196. Washout phase is day 85-112.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

84 day period on placebo compared to 84 day period on olanzapine

Results posted on

2011-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Olanzapine First, Then Placeb Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)	Placebo First, Then Olanzapine Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
First Intervention STARTED	3	0
First Intervention COMPLETED	1	0
First Intervention NOT COMPLETED	2	0
Second Intervention STARTED	1	0
Second Intervention COMPLETED	1	0
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Olanzapine First, Then Placeb Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)	Placebo First, Then Olanzapine Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
First Intervention Adverse Event	2	0

Baseline Characteristics

A Research Study Examining the Use of Olanzapine for the Prevention of Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olanzapine First, Then Placeb n=3 Participants Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)	Placebo First, Then Olanzapine Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).	Total n=3 Participants Total of all reporting groups
Age Categorical <=18 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age Categorical Between 18 and 65 years	3 participants n=5 Participants	—	3 participants n=5 Participants
Age Categorical >=65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age Continuous	50 years STANDARD_DEVIATION 3 • n=5 Participants	—	50 years STANDARD_DEVIATION 3 • n=5 Participants
Gender Female	2 participants n=5 Participants	—	2 participants n=5 Participants
Gender Male	1 participants n=5 Participants	—	1 participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	—	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 84 day period on placebo compared to 84 day period on olanzapine

Definition of migraine headache period: One migraine period is defined as a 24-hour period starting at the time of onset of the migraine headache, during which the migraine headache is present\*. Definition of time frames: First treatment period: Day 1 to 84. Second treatment period: day 113-196. Washout phase is day 85-112.

Outcome measures

Outcome measures
Measure	Olanzapine First, Then Placeb n=3 Participants Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)	Placebo First, Then Olanzapine Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
Difference in Migraine Headache Periods During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.	0 headache periods Standard Deviation 0	—

SECONDARY outcome

Timeframe: each 28 day interval of active treatment c ompared to placebo

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 84 day period on olanzapine compared to 84 day period on placebo

Outcome measures

Outcome data not reported

Adverse Events

Olanzapine First, Then Placeb

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo First, Then Olanzapine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Olanzapine First, Then Placeb n=3 participants at risk Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)	Placebo First, Then Olanzapine Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
Nervous system disorders lethargy	66.7% 2/3	— 0/0

Additional Information

Stephen D. Silberstein, M.D.- 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