Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine (NCT NCT04152083)
NCT ID: NCT04152083
Last Updated: 2021-08-17
Results Overview
Time to headache pain freedom defined as the time that the participant reported freedom of pain, meaning their headache pain had gone from moderate to severe at baseline to no pain.
COMPLETED
PHASE3
485 participants
Up to 48 hours postdose
2021-08-17
Participant Flow
Participants were randomized to receive either 100 milligrams (mg) eptinezumab or placebo in a 1:1 ratio.
Participant milestones
| Measure |
Eptinezumab
Participants received a single dose of eptinezumab 100 mg administered via intravenous (IV) infusion on Day 0.
|
Placebo
Participants received a single dose of placebo matched to eptinezumab administered via IV infusion on Day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
241
|
244
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
238
|
242
|
|
Overall Study
COMPLETED
|
235
|
241
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Eptinezumab
Participants received a single dose of eptinezumab 100 mg administered via intravenous (IV) infusion on Day 0.
|
Placebo
Participants received a single dose of placebo matched to eptinezumab administered via IV infusion on Day 0.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Randomized but not treated
|
3
|
2
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine
Baseline characteristics by cohort
| Measure |
Eptinezumab
n=238 Participants
Participants received a single dose of eptinezumab 100 mg administered via IV infusion on Day 0.
|
Placebo
n=242 Participants
Participants received a single dose of placebo matched to eptinezumab administered via IV infusion on Day 0.
|
Total
n=480 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 11.99 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 12.12 • n=7 Participants
|
44.5 years
STANDARD_DEVIATION 12.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
202 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
403 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
209 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
420 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
200 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
413 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
30 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Number of Migraine Days/Month
|
7.2 days/month
STANDARD_DEVIATION 2.65 • n=5 Participants
|
7.2 days/month
STANDARD_DEVIATION 2.56 • n=7 Participants
|
7.2 days/month
STANDARD_DEVIATION 2.60 • n=5 Participants
|
|
Number of Participants With Most Bothersome Symptoms (MBS)
Photophobia
|
114 participants
n=5 Participants
|
114 participants
n=7 Participants
|
228 participants
n=5 Participants
|
|
Number of Participants With Most Bothersome Symptoms (MBS)
Nausea
|
78 participants
n=5 Participants
|
79 participants
n=7 Participants
|
157 participants
n=5 Participants
|
|
Number of Participants With Most Bothersome Symptoms (MBS)
Phonophobia
|
46 participants
n=5 Participants
|
47 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Number of Participants With Most Bothersome Symptoms (MBS)
Missing
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48 hours postdosePopulation: Full analysis population (FAP) included all randomized participants who received eptinezumab or placebo.
Time to headache pain freedom defined as the time that the participant reported freedom of pain, meaning their headache pain had gone from moderate to severe at baseline to no pain.
Outcome measures
| Measure |
Eptinezumab
n=238 Participants
Participants received a single dose of eptinezumab 100 mg administered via IV infusion on Day 0.
|
Placebo
n=242 Participants
Participants received a single dose of placebo matched to eptinezumab administered via IV infusion on Day 0.
|
|---|---|---|
|
Time to Headache Pain Freedom
|
4.0 hours
Interval 2.5 to 12.0
|
9.0 hours
Interval 3.0 to 48.0
|
PRIMARY outcome
Timeframe: Up to 48 hours postdosePopulation: FAP included all randomized participants who received eptinezumab or placebo. Here, 'Overall number of participants analyzed' signifies participants with both baseline and post-baseline data (the symptom that was most bothersome).
Time to absence of most bothersome symptom defined as the time that the participant reported absence of MBS (of nausea, photophobia, or phonophobia).
Outcome measures
| Measure |
Eptinezumab
n=238 Participants
Participants received a single dose of eptinezumab 100 mg administered via IV infusion on Day 0.
|
Placebo
n=240 Participants
Participants received a single dose of placebo matched to eptinezumab administered via IV infusion on Day 0.
|
|---|---|---|
|
Time to Absence of Most Bothersome Symptom (MBS)
|
2.0 hours
Interval 1.0 to 3.5
|
3.0 hours
Interval 1.5 to 12.0
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: FAP included all randomized participants who received eptinezumab or placebo.
Number of participants with freedom from headache pain at 2 hours postdose are reported. Freedom from headache pain meaning that the headache pain that had gone from moderate to severe at baseline to no pain with no administration of rescue medications.
Outcome measures
| Measure |
Eptinezumab
n=238 Participants
Participants received a single dose of eptinezumab 100 mg administered via IV infusion on Day 0.
|
Placebo
n=242 Participants
Participants received a single dose of placebo matched to eptinezumab administered via IV infusion on Day 0.
|
|---|---|---|
|
Headache Pain Freedom at 2 Hours
|
56 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: FAP included all randomized participants who received eptinezumab or placebo. Here, 'Overall number of participants analyzed' signifies participants with both baseline and post-baseline data (the symptom that was most bothersome).
Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 2 hours postdose are reported.
Outcome measures
| Measure |
Eptinezumab
n=238 Participants
Participants received a single dose of eptinezumab 100 mg administered via IV infusion on Day 0.
|
Placebo
n=240 Participants
Participants received a single dose of placebo matched to eptinezumab administered via IV infusion on Day 0.
|
|---|---|---|
|
Absence of MBS at 2 Hours
|
132 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: FAP included all randomized participants who received eptinezumab or placebo.
Number of participants with freedom from headache pain at 4 hours postdose are reported. Freedom from headache pain meaning that the headache pain that had gone from moderate to severe at baseline to no pain with no administration of rescue medications.
Outcome measures
| Measure |
Eptinezumab
n=238 Participants
Participants received a single dose of eptinezumab 100 mg administered via IV infusion on Day 0.
|
Placebo
n=242 Participants
Participants received a single dose of placebo matched to eptinezumab administered via IV infusion on Day 0.
|
|---|---|---|
|
Headache Pain Freedom at 4 Hours
|
111 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: FAP included all randomized participants who received eptinezumab or placebo. Here, 'Overall number of participants analyzed' signifies participants with both baseline and post-baseline data (the symptom that was most bothersome).
Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 4 hours postdose are reported.
Outcome measures
| Measure |
Eptinezumab
n=238 Participants
Participants received a single dose of eptinezumab 100 mg administered via IV infusion on Day 0.
|
Placebo
n=240 Participants
Participants received a single dose of placebo matched to eptinezumab administered via IV infusion on Day 0.
|
|---|---|---|
|
Absence of MBS at 4 Hours
|
155 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: Up to 24 hours postdosePopulation: FAP included all randomized participants who received eptinezumab or placebo.
Rescue medication was defined as any medication to treat migraine or migraine-associated symptoms, which could have been provided to the participant any time after 2 hours post-start of infusion. Use of rescue medication was captured in the eDiary. Number of participants who used rescue medication up to 24 hours postdose are reported.
Outcome measures
| Measure |
Eptinezumab
n=238 Participants
Participants received a single dose of eptinezumab 100 mg administered via IV infusion on Day 0.
|
Placebo
n=242 Participants
Participants received a single dose of placebo matched to eptinezumab administered via IV infusion on Day 0.
|
|---|---|---|
|
Use of Rescue Medication Within the First 24 Hours
|
75 Participants
|
145 Participants
|
Adverse Events
Eptinezumab
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eptinezumab
n=238 participants at risk
Participants received a single dose of eptinezumab 100 mg administered via IV infusion on Day 0.
|
Placebo
n=242 participants at risk
Participants received a single dose of placebo matched to eptinezumab administered via IV infusion on Day 0.
|
|---|---|---|
|
Immune system disorders
Hypersensitivity
|
2.1%
5/238 • Number of events 5 • Start of treatment (Day 0) through end of study (Week 4)
Safety population included all participants who received eptinezumab or placebo.
|
0.00%
0/242 • Start of treatment (Day 0) through end of study (Week 4)
Safety population included all participants who received eptinezumab or placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place