Trial Outcomes & Findings for The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache (NCT NCT00719134)

Results Overview

The primary outcome measure was the change in headache between the baseline pain score recorded 30 min after the onset of headache and the pain score recorded 2 hours later as measured on a visual analog scale ranging from 0 (no pain) to 10 (worst pain imaginable).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

76 participants

Primary outcome timeframe

2 hours after treatment

Results posted on

2015-04-09

Participant Flow

Of 98 persons pre-screened for eligibility between December 2008 and March 2010, 19 were excluded and 3 declined to participate. The remaining 76 persons signed the consent form, but 10 of them dropped out of the study for various reasons. Participants were recruited from Beth Israel Deaconess Medical Center outpatient clinics.

Reasons for excluding 19 of the pre-screened subjects include chronic migraine, chronic daily headache, tension type headache, fibromyalgia, daily use of opioids, and medication overuse headache. We randomized participants to one of 8 treatment sequences and each patient received 3 treatments with Maxalt and 3 treatments with Placebo.

Participant milestones

Participant milestones
Measure	All Participants 76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.
Overall Study STARTED	76
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=76 Participants 76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.
Age, Continuous	40.6 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	76 participants n=5 Participants
Headache intensity	4.6 units on a scale STANDARD_DEVIATION 1.8 • n=5 Participants

PRIMARY outcome

Timeframe: 2 hours after treatment

Population: For the primary endpoint, change in headache intensity from baseline to 2 hours after treatment, we used generalized linear mixed models with a normal random component and a logarithmic link function to analyze the pain scores.

The primary outcome measure was the change in headache between the baseline pain score recorded 30 min after the onset of headache and the pain score recorded 2 hours later as measured on a visual analog scale ranging from 0 (no pain) to 10 (worst pain imaginable).

Outcome measures

Outcome measures
Measure	All Participants n=66 Participants
Change in Headache Intensity percent change with Maxalt	-47.6 percent change Interval -53.0 to -41.5
Change in Headache Intensity percent change with placebo	-20.7 percent change Interval -26.7 to -14.3

SECONDARY outcome

Timeframe: 2 hours after treatment

Population: For the secondary endpoint, the proportion of patients who were free from pain 2 hours after treatment, we used a mixed-effects logistic regression model to analyze the individual dichotomous outcomes.

A secondary measure of attack outcome was based on categorical classification of the pain freedom (pain score = 0) 2.5 hours after onset of headache.

Outcome measures

Outcome measures
Measure	All Participants n=66 Participants
Pain Free at 2 Hours After Treatment pain free with maxalt	25.5 percent of patients pain free Interval 17.2 to 36.2
Pain Free at 2 Hours After Treatment pain free with placebo	6.6 percent of patients pain free Interval 3.4 to 12.2

Adverse Events

Maxalt

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Maxalt n=66 participants at risk	Placebo n=66 participants at risk
Nervous system disorders Chest tightness	9.1% 6/66	7.6% 5/66
Nervous system disorders Heart palpitation	6.1% 4/66	9.1% 6/66
Nervous system disorders Throat tightness	10.6% 7/66	6.1% 4/66
Nervous system disorders Skin sensitivity	9.1% 6/66	4.5% 3/66
Nervous system disorders Gastrointestinal	12.1% 8/66	4.5% 3/66
Nervous system disorders Drowsiness	13.6% 9/66	1.5% 1/66

Additional Information

Rami Burstein

Beth Israel Deacxoness Medical Center

Phone: 617 735 2832

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place