Biomarker Study in Participants With Migraine

Early Phase 1

Completed

• Conditions: Migraine Disorders
• Interventions: Drug: Capsaicin

• Registration Number: NCT02766517
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-06
• Study First Posted: 2016-05-09
• Study Start: 2016-09-28
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-01
• Status Verified: 2017-02
• Results First Submitted: 2018-10-19
• Results First Submitted QC: 2018-10-19
• Results First Posted: 2019-02-26
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capsaicin	Capsaicin	Single topical dose of capsaicin

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (12)

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Pharmacology Research Institute, Newport Beach; 🇺🇸 Newport Beach, California, United States

Parexel Early Phase Unit at Glendale; 🇺🇸 Glendale, California, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

California Clinical Trials; 🇺🇸 San Diego, California, United States

Avail Clinical Research LLC; 🇺🇸 DeLand, Florida, United States

PharmaSite Research Inc; 🇺🇸 Baltimore, Maryland, United States

Rochester Clinical Research, Inc.; 🇺🇸 Rochester, New York, United States

PAREXEL-Phase 1 Baltimore Harbor Hospital Center; 🇺🇸 Baltimore, Maryland, United States

CNS Health Care; 🇺🇸 Memphis, Tennessee, United States

Northwest Clinical Research Center; 🇺🇸 Bellevue, Washington, United States

Psychiatric Inst of Florida-Clinical Neuroscience Solutions; 🇺🇸 Orlando, Florida, United States