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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Migraine Disorders
Intervention Drug: Capsaicin
Enrollment 37
Recruitment Details  
Pre-assignment Details Participants with migraine who had previously participated in the Phase 2 galcanezumab study, NCT02163993 [I5Q-MC-CGAB], and received either 120 milligram (mg) or 300 mg galcanezumab or placebo, with suitable skin characteristics for the dermal capsaicin challenge, were included in the I5Q-MC-S001 (NCT02766517) trial.
Arm/Group Title Placebo 120 mg Galcanezumab 300 mg Galcanezumab
Hide Arm/Group Description Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 microgram (mcg) capsaicin solution and vehicle topically in current study. Participants who received 120 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study. Participants who received 300 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
Period Title: Overall Study
Started 19 9 9
Completed 19 9 9
Not Completed 0 0 0
Arm/Group Title Placebo 120 mg Galcanezumab 300 mg Galcanezumab Total
Hide Arm/Group Description Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study. Participants who received 120 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study. Participants who received 300 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study. Total of all reporting groups
Overall Number of Baseline Participants 19 9 9 37
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 9 participants 9 participants 37 participants
42.1  (13.0) 47.6  (7.8) 42.3  (15.0) 43.5  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 9 participants 9 participants 37 participants
Female 15 6 7 28
Male 4 3 2 9
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 9 participants 9 participants 37 participants
Hispanic or Latino 3 0 3 6
Not Hispanic or Latino 16 9 6 31
Unknown or Not Reported 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 9 participants 9 participants 37 participants
American Indian or Alaska Native 0 0 0 0
Asian 1 0 0 1
Native Hawaiian or Other Pacific Islander 0 0 0 0
Black or African American 4 5 4 13
White 13 4 5 22
More than one race 1 0 0 1
Unknown or Not Reported 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 19 participants 9 participants 9 participants 37 participants
19 9 9 37
1.Primary Outcome
Title The Capsaicin-Induced Dermal Blood Flow (DBF)
Hide Description 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).
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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who have evaluable pharmacodynamics data.
Arm/Group Title Placebo 120 mg Galcanezumab 300 mg Galcanezumab
Hide Arm/Group Description:
Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
Participants who received 120 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
Participants who received 300 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
Overall Number of Participants Analyzed 19 7 9
Mean (Standard Deviation)
Unit of Measure: Flux mean
606.1  (615.6) 599.5  (514.7) 689.2  (552.3)
2.Primary Outcome
Title Plasma Calcitonin Gene-Related Peptide (CGRP) Levels
Hide Description The mean Plasma Calcitonin Gene-Related Peptide levels were reported.
Time Frame On assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who have evaluable pharmacodynamics data.
Arm/Group Title Placebo 120 mg Galcanezumab 300 mg Galcanezumab
Hide Arm/Group Description:
Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
Participants who received 120 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
Participants who received 300 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
Overall Number of Participants Analyzed 19 9 9
Mean (Standard Deviation)
Unit of Measure: picogram per milliliter (pg/mL)
1.748  (1.322) 1.082  (0.261) 1.370  (0.318)
Time Frame Day 1 to Day 3
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 120 mg Galcanezumab 300 mg Galcanezumab
Hide Arm/Group Description Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study. Participants who received 120 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study. Participants who received 300 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
All-Cause Mortality
Placebo 120 mg Galcanezumab 300 mg Galcanezumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo 120 mg Galcanezumab 300 mg Galcanezumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/9 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo 120 mg Galcanezumab 300 mg Galcanezumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/19 (15.79%)      1/9 (11.11%)      2/9 (22.22%)    
Gastrointestinal disorders       
Paraesthesia oral  1  0/19 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0
General disorders       
Application site erythema  1  2/19 (10.53%)  3 0/9 (0.00%)  0 0/9 (0.00%)  0
Pain  1  1/19 (5.26%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0
Infections and infestations       
Upper respiratory tract infection  1  1/19 (5.26%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0
Nervous system disorders       
Hypoaesthesia  1  1/19 (5.26%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0
Paraesthesia  1  1/19 (5.26%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders       
Erythema  1  1/19 (5.26%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0
Pruritus  1  0/19 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1
Vascular disorders       
Flushing  1  0/19 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: clinicaltrials.gov@lilly.com
Layout table for additonal information
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 Submitted: May 6, 2016
First Posted: May 9, 2016
Results First Submitted: October 19, 2018
Results First Posted: February 26, 2019
Last Update Posted: April 9, 2019