Biomarker Study in Participants With Migraine

Lilly

Status and phase

Completed

Early Phase 1

Conditions

Migraine Disorders

Treatments

Drug: Capsaicin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02766517

16235

I5Q-MC-S001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Volunteers

No Healthy Volunteers

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