Trial Outcomes & Findings for Biomarker Study in Participants With Migraine (NCT NCT02766517)
NCT ID: NCT02766517
Last Updated: 2019-04-09
Results Overview
Change from pre-capsaicin DBF adjusting for vehicle at 30 minutes is reported. The capsaicin induced dermal blood flow (DBF) was measured by laser Doppler imaging (LDI).
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
37 participants
Primary outcome timeframe
Baseline (pre-capsaicin) and on assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993
Results posted on
2019-04-09
Participant Flow
Participants with migraine who had previously participated in the Phase 2 galcanezumab study, NCT02163993 \[I5Q-MC-CGAB\], and received either 120 milligram (mg) or 300 mg galcanezumab or placebo, with suitable skin characteristics for the dermal capsaicin challenge, were included in the I5Q-MC-S001 (NCT02766517) trial.
Participant milestones
| Measure |
Placebo
Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 microgram (mcg) capsaicin solution and vehicle topically in current study.
|
120 mg Galcanezumab
Participants who received 120 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
|
300 mg Galcanezumab
Participants who received 300 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
9
|
9
|
|
Overall Study
COMPLETED
|
19
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biomarker Study in Participants With Migraine
Baseline characteristics by cohort
| Measure |
Placebo
n=19 Participants
Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
|
120 mg Galcanezumab
n=9 Participants
Participants who received 120 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
|
300 mg Galcanezumab
n=9 Participants
Participants who received 300 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
31 Participants
n=4 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
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-capsaicin) and on assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993Population: All enrolled participants who have evaluable pharmacodynamics data.
Change from pre-capsaicin DBF adjusting for vehicle at 30 minutes is reported. The capsaicin induced dermal blood flow (DBF) was measured by laser Doppler imaging (LDI).
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
|
120 mg Galcanezumab
n=7 Participants
Participants who received 120 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
|
300 mg Galcanezumab
n=9 Participants
Participants who received 300 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
|
|---|---|---|---|
|
The Capsaicin-Induced Dermal Blood Flow (DBF)
|
606.1 Flux mean
Standard Deviation 615.6
|
599.5 Flux mean
Standard Deviation 514.7
|
689.2 Flux mean
Standard Deviation 552.3
|
PRIMARY outcome
Timeframe: On assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993Population: All enrolled participants who have evaluable pharmacodynamics data.
The mean Plasma Calcitonin Gene-Related Peptide levels were reported.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
|
120 mg Galcanezumab
n=9 Participants
Participants who received 120 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
|
300 mg Galcanezumab
n=9 Participants
Participants who received 300 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
|
|---|---|---|---|
|
Plasma Calcitonin Gene-Related Peptide (CGRP) Levels
|
1.748 picogram per milliliter (pg/mL)
Standard Deviation 1.322
|
1.082 picogram per milliliter (pg/mL)
Standard Deviation 0.261
|
1.370 picogram per milliliter (pg/mL)
Standard Deviation 0.318
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
120 mg Galcanezumab
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
300 mg Galcanezumab
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=19 participants at risk
Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
|
120 mg Galcanezumab
n=9 participants at risk
Participants who received 120 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
|
300 mg Galcanezumab
n=9 participants at risk
Participants who received 300 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/19 • Day 1 to Day 3
|
11.1%
1/9 • Number of events 1 • Day 1 to Day 3
|
0.00%
0/9 • Day 1 to Day 3
|
|
General disorders
Application site erythema
|
10.5%
2/19 • Number of events 3 • Day 1 to Day 3
|
0.00%
0/9 • Day 1 to Day 3
|
0.00%
0/9 • Day 1 to Day 3
|
|
General disorders
Pain
|
5.3%
1/19 • Number of events 1 • Day 1 to Day 3
|
0.00%
0/9 • Day 1 to Day 3
|
0.00%
0/9 • Day 1 to Day 3
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • Number of events 1 • Day 1 to Day 3
|
0.00%
0/9 • Day 1 to Day 3
|
0.00%
0/9 • Day 1 to Day 3
|
|
Nervous system disorders
Hypoaesthesia
|
5.3%
1/19 • Number of events 1 • Day 1 to Day 3
|
0.00%
0/9 • Day 1 to Day 3
|
0.00%
0/9 • Day 1 to Day 3
|
|
Nervous system disorders
Paraesthesia
|
5.3%
1/19 • Number of events 1 • Day 1 to Day 3
|
0.00%
0/9 • Day 1 to Day 3
|
0.00%
0/9 • Day 1 to Day 3
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
1/19 • Number of events 1 • Day 1 to Day 3
|
0.00%
0/9 • Day 1 to Day 3
|
0.00%
0/9 • Day 1 to Day 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19 • Day 1 to Day 3
|
0.00%
0/9 • Day 1 to Day 3
|
11.1%
1/9 • Number of events 1 • Day 1 to Day 3
|
|
Vascular disorders
Flushing
|
0.00%
0/19 • Day 1 to Day 3
|
0.00%
0/9 • Day 1 to Day 3
|
11.1%
1/9 • Number of events 1 • Day 1 to Day 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER