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Biomarker Study in Participants With Migraine

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Capsaicin
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Migraine Disorders

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Arizona Research Center
  • Pharmacology Research Institute, Newport Beach
  • Parexel Early Phase Unit at Glendale
  • Pharmacology Research Institute, Newport Beach
  • Pharmacology Research Institute, Newport Beach
  • Medical Center for Clinical Research
  • California Clinical Trials
  • Avail Clinical Research LLC
  • Psychiatric Inst of Florida-Clinical Neuroscience Solutions
  • PharmaSite Research Inc
  • PAREXEL-Phase 1 Baltimore Harbor Hospital Center
  • Rochester Clinical Research, Inc.
  • CNS Health Care
  • Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capsaicin

Arm Description

Single topical dose of capsaicin

Outcomes

Primary Outcome Measures

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).
Plasma Calcitonin Gene-Related Peptide (CGRP) Levels
The mean Plasma Calcitonin Gene-Related Peptide levels were reported.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2016
Last Updated
March 29, 2019
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02766517
Brief Title
Biomarker Study in Participants With Migraine
Official Title
LY2951742 Biomarker Study in Patients With Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 28, 2016 (Actual)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capsaicin
Arm Type
Experimental
Arm Description
Single topical dose of capsaicin
Intervention Type
Drug
Intervention Name(s)
Capsaicin
Intervention Description
Administered topically
Primary Outcome Measure Information:
Title
The Capsaicin-Induced Dermal Blood Flow (DBF)
Description
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
Title
Plasma Calcitonin Gene-Related Peptide (CGRP) Levels
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Pharmacology Research Institute, Newport Beach
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Parexel Early Phase Unit at Glendale
City
Glendale
State/Province
California
ZIP/Postal Code
91206-4140
Country
United States
Facility Name
Pharmacology Research Institute, Newport Beach
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pharmacology Research Institute, Newport Beach
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
California Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Avail Clinical Research LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Psychiatric Inst of Florida-Clinical Neuroscience Solutions
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
PharmaSite Research Inc
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
CNS Health Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007-4209
Country
United States

12. IPD Sharing Statement

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Biomarker Study in Participants With Migraine

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