Trial Outcomes & Findings for Trial of Comprehensive Migraine Intervention (NCT NCT01071317)

Results Overview

This is a standardized instrument commonly used in migraine research. Participants answer 6 Likert questions about the impact of migraine on their daily life. A score of 36, the lowest possible score, indicates minimal functional impairment. A score of 78, the highest possible score, indicates substantial functional impairment

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

1 month after study enrollment

Results posted on

2018-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	Comprehensive Care Reinforcement of diagnosis, education, medications, and referral Naproxen: Naproxen 500mg PO bid prn headache Sumatriptan: 100mg po q day prn headache Migraine education: Educational program available through NIH/ national library of medicine/ X-plain Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria	Typical Care Usual care Typical care: Care to be determined by attending physician
Overall Study STARTED	25	25
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Comprehensive Care Reinforcement of diagnosis, education, medications, and referral Naproxen: Naproxen 500mg PO bid prn headache Sumatriptan: 100mg po q day prn headache Migraine education: Educational program available through NIH/ national library of medicine/ X-plain Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria	Typical Care Usual care Typical care: Care to be determined by attending physician
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Comprehensive Care n=25 Participants Reinforcement of diagnosis, education, medications, and referral Naproxen: Naproxen 500mg PO bid prn headache Sumatriptan: 100mg po q day prn headache Migraine education: Educational program available through NIH/ national library of medicine/ X-plain Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria	Typical Care n=25 Participants Usual care Typical care: Care to be determined by attending physician	Total n=50 Participants Total of all reporting groups
Age, Continuous	33 years STANDARD_DEVIATION 9 • n=25 Participants	35 years STANDARD_DEVIATION 9 • n=25 Participants	34 years STANDARD_DEVIATION 9 • n=50 Participants
Sex: Female, Male Female	23 Participants n=25 Participants	20 Participants n=25 Participants	43 Participants n=50 Participants
Sex: Female, Male Male	2 Participants n=25 Participants	5 Participants n=25 Participants	7 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	25 participants n=25 Participants	25 participants n=25 Participants	50 participants n=50 Participants
Pre-existing migraine-related functional impairment as measured by the MIDAS scale	10 units on a scale n=25 Participants	13 units on a scale n=25 Participants	12 units on a scale n=50 Participants

PRIMARY outcome

Timeframe: 1 month after study enrollment

Population: 2 patients in each group were lost-to-followup

This is a standardized instrument commonly used in migraine research. Participants answer 6 Likert questions about the impact of migraine on their daily life. A score of 36, the lowest possible score, indicates minimal functional impairment. A score of 78, the highest possible score, indicates substantial functional impairment

Outcome measures

Outcome measures
Measure	Comprehensive Care n=23 Participants Reinforcement of diagnosis, education, medications, and referral Naproxen: Naproxen 500mg PO bid prn headache Sumatriptan: 100mg po q day prn headache Migraine education: Educational program available through NIH/ national library of medicine/ X-plain Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria	Typical Care n=23 Participants Usual care Typical care: Care to be determined by attending physician
Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale	59 units on a scale Interval 53.0 to 65.0	56 units on a scale Interval 51.0 to 62.0

SECONDARY outcome

Timeframe: 1 month after study enrollment

Population: 2 patients in each group were lost to followup. One patient in the Typical Care group did not answer the question

Participants could report that they were completely satisfied, mostly satisfied or unsatisfied. Reported here are the number who were unsatisfied.

Outcome measures

Outcome measures
Measure	Comprehensive Care n=23 Participants Reinforcement of diagnosis, education, medications, and referral Naproxen: Naproxen 500mg PO bid prn headache Sumatriptan: 100mg po q day prn headache Migraine education: Educational program available through NIH/ national library of medicine/ X-plain Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria	Typical Care n=22 Participants Usual care Typical care: Care to be determined by attending physician
Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 1 month after study enrollment

Population: Two patients in each arm were lost-to-follow-up. One patient in Typical Care did not answer this question.

Participants were asked to describe themselves as very comfortable, somewhat comfortable, or uncomfortable. Reported here are those who were very comfortable

Outcome measures

Outcome measures
Measure	Comprehensive Care n=23 Participants Reinforcement of diagnosis, education, medications, and referral Naproxen: Naproxen 500mg PO bid prn headache Sumatriptan: 100mg po q day prn headache Migraine education: Educational program available through NIH/ national library of medicine/ X-plain Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria	Typical Care n=22 Participants Usual care Typical care: Care to be determined by attending physician
Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale	10 Participants	6 Participants

SECONDARY outcome

Timeframe: 1 month after study enrollment

Population: Two patients in each arm were lost to followup.

We report the number of patient who returned to the emergency department for management of headache

Outcome measures

Outcome measures
Measure	Comprehensive Care n=23 Participants Reinforcement of diagnosis, education, medications, and referral Naproxen: Naproxen 500mg PO bid prn headache Sumatriptan: 100mg po q day prn headache Migraine education: Educational program available through NIH/ national library of medicine/ X-plain Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria	Typical Care n=23 Participants Usual care Typical care: Care to be determined by attending physician
Number of Participants Who Returned to the Emergency Department for Management of Headache	1 Participants	3 Participants

Adverse Events

Comprehensive Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Typical Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Benjamin W. Friedman, MD

Montefiore Health

Phone: 718-920-6626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place