Migraine Disorders
Conditions
Brief summary
This is a study of participants with a diagnosis of migraine who completed another clinical trial NCT02163993. The participants received either LY2951742 or placebo. This study NCT02766517 will evaluate how certain biomarkers may be related to the participant's response in study NCT02163993. The study will last about five days.
Interventions
DRUGCapsaicin
Administered topically
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants with migraine who have previously participated in study NTC02163993 and received one of the selected doses of galcanezumab or placebo * Have suitable skin characteristics for the dermal capsaicin challenge
Exclusion criteria
* Have a history of significant allergies, in particular to ethanol or sensitivity to the fruits of capsicum plants (for example, chili peppers) * Have eczema, scleroderma, psoriasis, dermatitis, keloids, tumors, ulcers, burns, flaps, or grafts on their forearm or other abnormality of the skin which may interfere with the study assessments * Cannot avoid excess tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover forearms for 24 hours prior to each treatment period * Have excessive hair growth on the volar surface of the forearm or participants currently using lotions, oils, depilatory preparations, or other topical treatments on a regular basis which cannot be discontinued for the duration of the study; has used any topical treatments within 7 days of the start of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Capsaicin-Induced Dermal Blood Flow (DBF) | Baseline (pre-capsaicin) and on assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993 | 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). |
| Plasma Calcitonin Gene-Related Peptide (CGRP) Levels | On assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993 | The mean Plasma Calcitonin Gene-Related Peptide levels were reported. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study. | 19 |
| 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. | 9 |
| 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. | 9 |
| Total | 37 |
Baseline characteristics
| Characteristic | Placebo | Total | 300 mg Galcanezumab | 120 mg Galcanezumab |
|---|---|---|---|---|
| Age, Continuous | 42.1 years STANDARD_DEVIATION 13 | 43.5 years STANDARD_DEVIATION 12.4 | 42.3 years STANDARD_DEVIATION 15 | 47.6 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 31 Participants | 6 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 13 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 22 Participants | 5 Participants | 4 Participants |
| Region of Enrollment United States | 19 Participants | 37 Participants | 9 Participants | 9 Participants |
| Sex: Female, Male Female | 15 Participants | 28 Participants | 7 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 19 | 1 / 9 | 2 / 9 |
| serious Total, serious adverse events | 0 / 19 | 0 / 9 | 0 / 9 |
Outcome results
Primary
Plasma Calcitonin Gene-Related Peptide (CGRP) Levels
The mean Plasma Calcitonin Gene-Related Peptide levels were reported.
Time frame: On assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993
Population: All enrolled participants who have evaluable pharmacodynamics data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Plasma Calcitonin Gene-Related Peptide (CGRP) Levels | 1.748 picogram per milliliter (pg/mL) | Standard Deviation 1.322 |
| 120 mg Galcanezumab | Plasma Calcitonin Gene-Related Peptide (CGRP) Levels | 1.082 picogram per milliliter (pg/mL) | Standard Deviation 0.261 |
| 300 mg Galcanezumab | Plasma Calcitonin Gene-Related Peptide (CGRP) Levels | 1.370 picogram per milliliter (pg/mL) | Standard Deviation 0.318 |
Primary
The Capsaicin-Induced Dermal Blood Flow (DBF)
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).
Time frame: Baseline (pre-capsaicin) and on assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993
Population: All enrolled participants who have evaluable pharmacodynamics data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The Capsaicin-Induced Dermal Blood Flow (DBF) | 606.1 Flux mean | Standard Deviation 615.6 |
| 120 mg Galcanezumab | The Capsaicin-Induced Dermal Blood Flow (DBF) | 599.5 Flux mean | Standard Deviation 514.7 |
| 300 mg Galcanezumab | The Capsaicin-Induced Dermal Blood Flow (DBF) | 689.2 Flux mean | Standard Deviation 552.3 |