Trial Outcomes & Findings for A Research Study To Evaluate If Frovatriptan Is Safe And Effective In Preventing Migraine Headache After Fasting (NCT NCT00440232)

Results Overview

Incidence of fasting-induced headache of any intensity occurring at greater than 4 hours, but within 20 hours after onset of fasting

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

74 participants

Primary outcome timeframe

20 hours

Results posted on

2011-05-26

Participant Flow

Eligible participants were recruited from our office practice or surrounding community from 7/16/07 through 3/18/09

Participant milestones

Participant milestones
Measure	Frovatriptan 5.0 mg of Frovatriptan given as single dose	Placebo
Overall Study STARTED	36	38
Overall Study COMPLETED	33	34
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Frovatriptan 5.0 mg of Frovatriptan given as single dose	Placebo
Overall Study Lost to Follow-up	1	1
Overall Study Unable to treat within allowed time	0	1
Overall Study Onset of headache within 4 hours of fast	2	2

Baseline Characteristics

A Research Study To Evaluate If Frovatriptan Is Safe And Effective In Preventing Migraine Headache After Fasting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Frovatriptan n=36 Participants 5.0 mg of Frovatriptan given as single dose	Placebo n=38 Participants	Total n=74 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	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	40.15 years STANDARD_DEVIATION 11.8 • n=5 Participants	38.7 years STANDARD_DEVIATION 12.7 • n=7 Participants	39.49 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	38 participants n=7 Participants	74 participants n=5 Participants

PRIMARY outcome

Timeframe: 20 hours

Incidence of fasting-induced headache of any intensity occurring at greater than 4 hours, but within 20 hours after onset of fasting

Outcome measures

Outcome measures
Measure	Frovatriptan n=33 Participants 5.0 mg of Frovatriptan given as single dose	Placebo n=34 Participants
Incidence of Fasting-induced Headache of Any Intensity	12 participants	18 participants

SECONDARY outcome

Timeframe: 20 hours

Time to development of headache of any intensity in the 2 treatment arms

Outcome measures

Outcome measures
Measure	Frovatriptan n=33 Participants 5.0 mg of Frovatriptan given as single dose	Placebo n=34 Participants
Time to Development of Headache of Any Intensity	17.388 hours Interval 16.05 to 18.73	17.06 hours Interval 15.72 to 18.4

Adverse Events

Frovatriptan

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Frovatriptan n=35 participants at risk 5.0 mg of Frovatriptan given as single dose	Placebo n=36 participants at risk
Gastrointestinal disorders nausea	0.00% 0/35	8.3% 3/36 • Number of events 3
General disorders sleepiness/fatigue	2.9% 1/35 • Number of events 1	5.6% 2/36 • Number of events 2

Additional Information

Stephen D. Silberstein, M.D.

Jefferson Headache Center/Thomas Jefferson University

Phone: 215-955-2243

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place