Trial Outcomes & Findings for Real World Effectiveness of Eptinezumab in Participants With Migraine (NCT NCT05284019)

Last Updated: 2024-05-29

Results Overview

Participants select the symptom that they find most impairs them at the time of reporting and rate the severity of that symptom on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

32 participants

Primary outcome timeframe

Baseline, Week 24

Results posted on

2024-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	Erenumab Participants received erenumab SC every 28 days, as per the product label for 6 months.	Fremanezumab Participants received fremanezumab SC every 28 days or every 84 days, as per the product label for 6 months.	Onabotulinumtoxin-A Participants received onabotulinumtoxin-A SC at Baseline (Day 0) and Week 12.	Galcanezumab Participants received galcanezumab loading dose SC as applicable followed by dosing every 28 days, as per the product label for 5 months.	Eptinezumab Participants received eptinezumab via IV infusion, as per the product label at Baseline (Day 0) and Week 12.
Overall Study STARTED	3	2	2	8	17
Overall Study Received at Least 1 Dose of Study Drug	3	2	2	8	16
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	3	2	2	8	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Erenumab Participants received erenumab SC every 28 days, as per the product label for 6 months.	Fremanezumab Participants received fremanezumab SC every 28 days or every 84 days, as per the product label for 6 months.	Onabotulinumtoxin-A Participants received onabotulinumtoxin-A SC at Baseline (Day 0) and Week 12.	Galcanezumab Participants received galcanezumab loading dose SC as applicable followed by dosing every 28 days, as per the product label for 5 months.	Eptinezumab Participants received eptinezumab via IV infusion, as per the product label at Baseline (Day 0) and Week 12.
Overall Study Study terminated	2	2	2	5	15
Overall Study Withdrawal by Subject	0	0	0	1	1
Overall Study Lost to Follow-up	1	0	0	2	1

Baseline Characteristics

Real World Effectiveness of Eptinezumab in Participants With Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erenumab n=3 Participants Participants received erenumab SC every 28 days, as per the product label for 6 months.	Fremanezumab n=2 Participants Participants received fremanezumab SC every 28 days or every 84 days, as per the product label for 6 months.	Onabotulinumtoxin-A n=2 Participants Participants received onabotulinumtoxin-A SC at Baseline (Day 0) and Week 12.	Galcanezumab n=8 Participants Participants received galcanezumab loading dose SC as applicable followed by dosing every 28 days, as per the product label for 5 months.	Eptinezumab n=17 Participants Participants received eptinezumab via IV infusion, as per the product label at Baseline (Day 0) and Week 12.	Total n=32 Participants Total of all reporting groups
Age, Continuous	47.3 years STANDARD_DEVIATION 6.4 • n=5 Participants	60.5 years STANDARD_DEVIATION 4.9 • n=7 Participants	30.5 years STANDARD_DEVIATION 17.7 • n=5 Participants	43.1 years STANDARD_DEVIATION 12.6 • n=4 Participants	38.2 years STANDARD_DEVIATION 10.5 • n=21 Participants	41.2 years STANDARD_DEVIATION 12.1 • n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	15 Participants n=21 Participants	28 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	9 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	12 Participants n=21 Participants	23 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	10 Participants n=8 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants	21 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Analysis was performed on the full analysis set (FAS), which included all participants who completed at least one daily report after receiving eptinezumab or other advanced migraine therapy. Due to the small sample size, data was not reported for participant confidentiality reasons.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to Week 24

Population: Analysis was performed on the FAS, which included all participants who completed at least one daily report after receiving eptinezumab or other advanced migraine therapy. Due to the small sample size, data was not reported for participant confidentiality reasons.

The participants report the number of "good days" and "bad days" they had in the previous week on a weekly basis using the good day/bad day scale.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, Week 24

The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analog scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to Week 24

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to Week 24

The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item is rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 is the sum of each response score ranging from 36 to 78. The life impact derived from the total score is described as follows: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to Week 24

The Midas score is a participant completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Week 24

The TSQM assesses four domains of participants' satisfaction with treatment, with scale ranges from 0 (extremely dissatisfied) to 100 (not at all dissatisfied) for each of the categories (Effectiveness, Side Effects, Convenience, and Overall Satisfaction).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Week 24