Biomarker Study in Participants With Migraine

NCT ID: NCT02766517

Last Updated: 2019-04-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-28

Study Completion Date

2017-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Capsaicin

Single topical dose of capsaicin

Group Type EXPERIMENTAL

Capsaicin

Intervention Type DRUG

Administered topically

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Capsaicin

Administered topically

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arizona Research Center

Phoenix, Arizona, United States

Site Status

Pharmacology Research Institute, Newport Beach

Encino, California, United States

Site Status

Parexel Early Phase Unit at Glendale

Glendale, California, United States

Site Status

Pharmacology Research Institute, Newport Beach

Los Alamitos, California, United States

Site Status

Pharmacology Research Institute, Newport Beach

Newport Beach, California, United States

Site Status

Medical Center for Clinical Research

San Diego, California, United States

Site Status

California Clinical Trials

San Diego, California, United States

Site Status

Avail Clinical Research LLC

DeLand, Florida, United States

Site Status

Psychiatric Inst of Florida-Clinical Neuroscience Solutions

Orlando, Florida, United States

Site Status

PharmaSite Research Inc

Baltimore, Maryland, United States

Site Status

PAREXEL-Phase 1 Baltimore Harbor Hospital Center

Baltimore, Maryland, United States

Site Status

Rochester Clinical Research, Inc.

Rochester, New York, United States

Site Status

CNS Health Care

Memphis, Tennessee, United States

Site Status

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

I5Q-MC-S001

Identifier Type: OTHER

Identifier Source: secondary_id

16235

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study in Migraine Prevention
NCT01184508 TERMINATED PHASE2