Biomarker Study in Participants With Migraine

NCT02766517 | Completed Early Phase 1 Results

• 2 other identifiers: 16235I5Q-MC-S001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 14

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.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Capsaicin

EXPERIMENTAL

Single topical dose of capsaicin

Drug: Capsaicin

Interventions

Capsaicin DRUG

Administered topically

Capsaicin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (14)

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Pharmacology Research Institute, Newport Beach

Encino, California, 91316, United States

Location

Parexel Early Phase Unit at Glendale

Glendale, California, 91206-4140, United States

Location

Pharmacology Research Institute, Newport Beach

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute, Newport Beach

Newport Beach, California, 92660, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

California Clinical Trials

San Diego, California, 92123, United States

Location

Avail Clinical Research LLC

DeLand, Florida, 32720, United States

Location

Psychiatric Inst of Florida-Clinical Neuroscience Solutions

Orlando, Florida, 32801, United States

Location

PharmaSite Research Inc

Baltimore, Maryland, 21208, United States

Location

PAREXEL-Phase 1 Baltimore Harbor Hospital Center

Baltimore, Maryland, 21225, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

CNS Health Care

Memphis, Tennessee, 38119, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007-4209, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

clinicaltrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 9, 2016
• Study Start: September 28, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 9, 2019
• Results First Posted: February 26, 2019

Record last verified: 2017-02

Locations

US (14)