Clinical trial NCT02766517: Biomarker Study in Participants With Migraine
Official title: LY2951742 Biomarker Study in Patients With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Migraine Disorders
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-05-09
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: The Capsaicin-Induced Dermal Blood Flow (DBF)
timeFrame: Baseline (pre-capsaicin) and on assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993
measure: Plasma Calcitonin Gene-Related Peptide (CGRP) Levels
timeFrame: On assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Encino
country: United States
facility: Pharmacology Research Institute, Newport Beach
state: California
city: Glendale
country: United States
facility: Parexel Early Phase Unit at Glendale
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute, Newport Beach
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute, Newport Beach
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Diego
country: United States
facility: California Clinical Trials
state: California
city: DeLand
country: United States
facility: Avail Clinical Research LLC
state: Florida
city: Orlando
country: United States
facility: Psychiatric Inst of Florida-Clinical Neuroscience Solutions
state: Florida
city: Baltimore
country: United States
facility: PharmaSite Research Inc
state: Maryland
city: Baltimore
country: United States
facility: PAREXEL-Phase 1 Baltimore Harbor Hospital Center
state: Maryland
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Memphis
country: United States
facility: CNS Health Care
state: Tennessee
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: