Trial Outcomes & Findings for A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache (NCT NCT00443352)

Last Updated: 2014-05-26

Results Overview

Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

27 participants

Primary outcome timeframe

Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).

Results posted on

2014-05-26

Participant Flow

Participant milestones

Participant milestones
Measure	Duloxetine Duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
Overall Study STARTED	27
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duloxetine Completers n=27 Participants duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
Age, Continuous	38.4 years STANDARD_DEVIATION 11.4 • n=39 Participants
Sex: Female, Male Female	20 Participants n=39 Participants
Sex: Female, Male Male	7 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	5 Participants n=39 Participants
Race (NIH/OMB) White	22 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants

PRIMARY outcome

Timeframe: Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).

Population: Number of participants for analysis was modified intention to treat - anyone who took at least one dose of duloxetine

Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).

Outcome measures

Outcome measures
Measure	Duloxetine n=27 Participants duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
Change in Frequency of Migraine Days During the Last 28 Day Interval of the Treatment Period as Compared to the 28 Day Baseline Period.	4.5 days Standard Deviation 3.4

Adverse Events

Duloxetine

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Duloxetine n=27 participants at risk duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
General disorders Dry mouth	18.5% 5/27 • Number of events 5
Gastrointestinal disorders Nausea	29.6% 8/27 • Number of events 8
General disorders Fatigue	7.4% 2/27 • Number of events 2

Additional Information

William B Young, MD

Thomas Jefferson University

Phone: 215-955-2243

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place