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Trial record 61 of 231 for:    CALCITONIN SALMON

Biomarker Study in Participants With Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02766517
Recruitment Status : Completed
First Posted : May 9, 2016
Results First Posted : February 26, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: Capsaicin Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: LY2951742 Biomarker Study in Patients With Migraine
Actual Study Start Date : September 28, 2016
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Capsaicin

Arm Intervention/treatment
Experimental: Capsaicin
Single topical dose of capsaicin
Drug: Capsaicin
Administered topically




Primary Outcome Measures :
  1. The Capsaicin-Induced Dermal Blood Flow (DBF) [ 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 ]
    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).

  2. Plasma Calcitonin Gene-Related Peptide (CGRP) Levels [ Time Frame: On assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993 ]
    The mean Plasma Calcitonin Gene-Related Peptide levels were reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766517


Locations
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United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, California
Pharmacology Research Institute, Newport Beach
Encino, California, United States, 91316
Parexel Early Phase Unit at Glendale
Glendale, California, United States, 91206-4140
Pharmacology Research Institute, Newport Beach
Los Alamitos, California, United States, 90720
Pharmacology Research Institute, Newport Beach
Newport Beach, California, United States, 92660
Medical Center for Clinical Research
San Diego, California, United States, 92108
California Clinical Trials
San Diego, California, United States, 92123
United States, Florida
Avail Clinical Research LLC
DeLand, Florida, United States, 32720
Psychiatric Inst of Florida-Clinical Neuroscience Solutions
Orlando, Florida, United States, 32801
United States, Maryland
PharmaSite Research Inc
Baltimore, Maryland, United States, 21208
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
Baltimore, Maryland, United States, 21225
United States, New York
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
United States, Tennessee
CNS Health Care
Memphis, Tennessee, United States, 38119
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007-4209
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02766517     History of Changes
Other Study ID Numbers: 16235
I5Q-MC-S001 ( Other Identifier: Eli Lilly and Company )
First Posted: May 9, 2016    Key Record Dates
Results First Posted: February 26, 2019
Last Update Posted: April 9, 2019
Last Verified: February 2017
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs