Biomarker Study in Participants With Migraine

March 29, 2019 updated by: Eli Lilly and Company

LY2951742 Biomarker Study in Patients 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
    • California
      • Encino, California, United States, 91316
        • Pharmacology Research Institute, Newport Beach
      • Glendale, California, United States, 91206-4140
        • Parexel Early Phase Unit at Glendale
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute, Newport Beach
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute, Newport Beach
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
      • San Diego, California, United States, 92123
        • California Clinical Trials
    • Florida
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research LLC
      • Orlando, Florida, United States, 32801
        • Psychiatric Inst of Florida-Clinical Neuroscience Solutions
    • Maryland
      • Baltimore, Maryland, United States, 21225
        • PAREXEL-Phase 1 Baltimore Harbor Hospital Center
      • Baltimore, Maryland, United States, 21208
        • Pharmasite Research Inc
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc.
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • CNS Health Care
    • Washington
      • Bellevue, Washington, United States, 98007-4209
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Capsaicin
Single topical dose of capsaicin
Drug: Capsaicin
Administered topically

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (pre-capsaicin) and on assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993
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.
On assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

May 6, 2016

First Submitted That Met QC Criteria

May 6, 2016

First Posted (Estimate)

May 9, 2016

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

March 29, 2019

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16235
  • I5Q-MC-S001 (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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