Trial Outcomes & Findings for Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action (NCT NCT04271202)
NCT ID: NCT04271202
Last Updated: 2026-03-24
Results Overview
Measure difference in gray matter thickness (as measured in MRI images) in study time frame
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
baseline MRI (day 0), treatment effect MRI (day 90)
Results posted on
2026-03-24
Participant Flow
Participant milestones
| Measure |
Open Label Treatment With no Placebo or Control
Effects of galacenezumab (emgality) treatment (injectable 240 mg initial dose followed by 120 mg treatments 1, 2 and 3 month later) on brain functioning and number of migraine days per month.
Emgality 120 MG in 1 ML Prefilled Syringe: Initial dose of 240 mg followed by 2 interventions (1 month apart) of 120 mg - all given as injectables.
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Open Label Treatment With no Placebo or Control
Effects of galacenezumab (emgality) treatment (injectable 240 mg initial dose followed by 120 mg treatments 1, 2 and 3 month later) on brain functioning and number of migraine days per month.
Emgality 120 MG in 1 ML Prefilled Syringe: Initial dose of 240 mg followed by 2 interventions (1 month apart) of 120 mg - all given as injectables.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
18
|
|
Overall Study
Lost to Follow-up
|
10
|
Baseline Characteristics
Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action
Baseline characteristics by cohort
| Measure |
Treatment
n=64 Participants
Effects of galacenezumab (emgality) treatment (injectable 240 mg initial dose followed by 120 mg treatments 1 and 2 month later) on brain functioning.
Emgality 120 MG in 1 ML Prefilled Syringe: Initial dose of 240 mg followed by 2 interventions (1 month apart) of 120 mg - all given as injectables.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=138 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=138 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=138 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=138 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=138 Participants
|
|
Race/Ethnicity, Customized
white
|
58 Participants
n=138 Participants
|
|
Race/Ethnicity, Customized
black or African American
|
3 Participants
n=138 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=138 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other pacific islands
|
0 Participants
n=138 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan native
|
0 Participants
n=138 Participants
|
|
Race/Ethnicity, Customized
multiracial
|
1 Participants
n=138 Participants
|
|
Race/Ethnicity, Customized
other
|
1 Participants
n=138 Participants
|
PRIMARY outcome
Timeframe: baseline MRI (day 0), treatment effect MRI (day 90)Population: Migraine patients that completed both pre and post treatment MRI visits.
Measure difference in gray matter thickness (as measured in MRI images) in study time frame
Outcome measures
| Measure |
Responders
n=19 Participants
Participants with a \>50% reduction in headache days per month after treatment
|
Non-Responders
n=17 Participants
Participants with \<50% reduction in headache days per month after treatment
|
|---|---|---|
|
Change in Gray Matter Thickness in the Somatosensory Cortex
|
-0.043 mm
Interval -0.096 to -0.016
|
0 mm
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: baseline MRI (day 0), treatment effect MRI (day 90)Population: Migraine patients that completed both pre and post treatment MRI visits.
Measure difference in gray matter thickness (as measured in MRI images) in study time frame
Outcome measures
| Measure |
Responders
n=19 Participants
Participants with a \>50% reduction in headache days per month after treatment
|
Non-Responders
n=17 Participants
Participants with \<50% reduction in headache days per month after treatment
|
|---|---|---|
|
Change in Gray Matter Thickness in Right Frontal Cortex
|
-0.047 mm
Interval -0.118 to -0.0008
|
0 mm
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: baseline MRI (day 0), treatment effect MRI (day 90)Population: Migraine patients that completed both pre and post treatment MRI visits.
Measure difference in gray matter thickness (as measured in MRI images) in study time frame
Outcome measures
| Measure |
Responders
n=19 Participants
Participants with a \>50% reduction in headache days per month after treatment
|
Non-Responders
n=17 Participants
Participants with \<50% reduction in headache days per month after treatment
|
|---|---|---|
|
Change in Gray Matter Thickness in Right Supra Marginal Cortex
|
-0.039 mm
Interval -0.074 to -0.005
|
0 mm
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: baseline MRI (day 0), treatment effect MRI (day 90)Population: Migraine patients that completed both pre and post treatment MRI visits.
Measure difference in gray matter thickness (as measured in MRI images) in study time frame
Outcome measures
| Measure |
Responders
n=19 Participants
Participants with a \>50% reduction in headache days per month after treatment
|
Non-Responders
n=17 Participants
Participants with \<50% reduction in headache days per month after treatment
|
|---|---|---|
|
Change in Gray Matter Thickness in Left Frontal Cortex
|
-0.059 mm
Interval -0.098 to -0.023
|
0 mm
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: baseline MRI (day 0), treatment effect MRI (day 90)Population: Migraine patients that completed both pre and post treatment MRI visits.
Measure difference in gray matter thickness (as measured in MRI images) in study time frame
Outcome measures
| Measure |
Responders
n=19 Participants
Participants with a \>50% reduction in headache days per month after treatment
|
Non-Responders
n=17 Participants
Participants with \<50% reduction in headache days per month after treatment
|
|---|---|---|
|
Change in Gray Matter Thickness in the Left Superior Frontal Gyrus
|
0 mm
Interval 0.0 to 0.0
|
-0.061 mm
Interval -0.11 to -0.029
|
PRIMARY outcome
Timeframe: baseline MRI (day 0), treatment effect MRI (day 90)Population: Migraine patients that completed both pre and post treatment MRI visits.
Measure difference in gray matter thickness (as measured in MRI images) in study time frame
Outcome measures
| Measure |
Responders
n=19 Participants
Participants with a \>50% reduction in headache days per month after treatment
|
Non-Responders
n=17 Participants
Participants with \<50% reduction in headache days per month after treatment
|
|---|---|---|
|
Change in Gray Matter Thickness in the Left Medial Superior Frontal Gyrus
|
0 mm
Interval 0.0 to 0.0
|
-0.055 mm
Interval -0.09 to -0.04
|
Adverse Events
Open Label Treatment With no Placebo or Control
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Open Label Treatment With no Placebo or Control
n=64 participants at risk
Effects of galacenezumab (emgality) treatment (injectable 240 mg initial dose followed by 120 mg treatments 1, 2 and 3 month later) on brain functioning and number of migraine days per month.
Emgality 120 MG in 1 ML Prefilled Syringe: Initial dose of 240 mg followed by 2 interventions (1 month apart) of 120 mg - all given as injectables.
|
|---|---|
|
Nervous system disorders
dizziness
|
1.6%
1/64 • Number of events 1 • Adverse events were collected over a period of 1 year from the time treatment was initiated (on day 30 of the study).
Patient developed random but prolonged episodes of dizziness described as "feeling of falling" and weakness of the legs, with associated lightheadedness; each episode lasting between 30 to 60 seconds with no triggers or precipitating events. Participants went to an urgent care center, where she was evaluated and referred to the emergency room at BIDMC, and was admitted for observation.
|
Other adverse events
| Measure |
Open Label Treatment With no Placebo or Control
n=64 participants at risk
Effects of galacenezumab (emgality) treatment (injectable 240 mg initial dose followed by 120 mg treatments 1, 2 and 3 month later) on brain functioning and number of migraine days per month.
Emgality 120 MG in 1 ML Prefilled Syringe: Initial dose of 240 mg followed by 2 interventions (1 month apart) of 120 mg - all given as injectables.
|
|---|---|
|
Nervous system disorders
dizziness
|
1.6%
1/64 • Number of events 1 • Adverse events were collected over a period of 1 year from the time treatment was initiated (on day 30 of the study).
Patient developed random but prolonged episodes of dizziness described as "feeling of falling" and weakness of the legs, with associated lightheadedness; each episode lasting between 30 to 60 seconds with no triggers or precipitating events. Participants went to an urgent care center, where she was evaluated and referred to the emergency room at BIDMC, and was admitted for observation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place