Biomarker Study in Participants With Migraine

Migraine Disorders Clinical Trial

Official title:

LY2951742 Biomarker Study in Patients With Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766517
• Other study ID #: 16235
• Secondary ID: I5Q-MC-S001
• Status: Completed
• Phase: Early Phase 1
• Start date: September 28, 2016
• Est. completion date: January 1, 2017

Study information

• Verified date: February 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• Capsaicin
Administered topically

Locations

Country	Name	City	State
United States	PAREXEL-Phase 1 Baltimore Harbor Hospital Center	Baltimore	Maryland
United States	PharmaSite Research Inc	Baltimore	Maryland
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Avail Clinical Research LLC	DeLand	Florida
United States	Pharmacology Research Institute, Newport Beach	Encino	California
United States	Parexel Early Phase Unit at Glendale	Glendale	California
United States	Pharmacology Research Institute, Newport Beach	Los Alamitos	California
United States	CNS Health Care	Memphis	Tennessee
United States	Pharmacology Research Institute, Newport Beach	Newport Beach	California
United States	Psychiatric Inst of Florida-Clinical Neuroscience Solutions	Orlando	Florida
United States	Arizona Research Center	Phoenix	Arizona
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	California Clinical Trials	San Diego	California
United States	Medical Center for Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline (pre-capsaicin) and on assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993
Primary	Plasma Calcitonin Gene-Related Peptide (CGRP) Levels	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