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Completed

NCT Number: NCT02766517

Biomarker Study in Participants With Migraine

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.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Arizona Research Center, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capsaicin

Drug

Administered topically

Primary outcomes

  1. The Capsaicin-Induced Dermal Blood Flow (DBF)

    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

    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).

  2. Plasma Calcitonin Gene-Related Peptide (CGRP) Levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

LY2951742 Biomarker Study in Patients With Migraine

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 9, 2016
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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