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| ID | Type | Description | Link |
|---|---|---|---|
| I5Q-MC-S001 | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capsaicin | Experimental | Single topical dose of capsaicin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin | Drug | Administered topically |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85023 | United States | ||
| Pharmacology Research Institute, Newport Beach |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 microgram (mcg) capsaicin solution and vehicle topically in current study. |
| FG001 | 120 mg Galcanezumab | 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. |
| FG002 | 300 mg Galcanezumab | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study. |
| BG001 | 120 mg Galcanezumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All enrolled participants who have evaluable pharmacodynamics data. | Posted | Mean | Standard Deviation | Flux mean | Baseline (pre-capsaicin) and on assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993 |
|
Day 1 to Day 3
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | clinicaltrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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| Encino |
| California |
| 91316 |
| United States |
| Parexel Early Phase Unit at Glendale | Glendale | California | 91206-4140 | United States |
| Pharmacology Research Institute, Newport Beach | Los Alamitos | California | 90720 | United States |
| Pharmacology Research Institute, Newport Beach | Newport Beach | California | 92660 | United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| California Clinical Trials | San Diego | California | 92123 | United States |
| Avail Clinical Research LLC | DeLand | Florida | 32720 | United States |
| Psychiatric Inst of Florida-Clinical Neuroscience Solutions | Orlando | Florida | 32801 | United States |
| PharmaSite Research Inc | Baltimore | Maryland | 21208 | United States |
| PAREXEL-Phase 1 Baltimore Harbor Hospital Center | Baltimore | Maryland | 21225 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| CNS Health Care | Memphis | Tennessee | 38119 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007-4209 | United States |
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.
| BG002 | 300 mg Galcanezumab | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
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.
| OG002 | 300 mg Galcanezumab | 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. |
|
|
| Primary | Plasma Calcitonin Gene-Related Peptide (CGRP) Levels | The mean Plasma Calcitonin Gene-Related Peptide levels were reported. | All enrolled participants who have evaluable pharmacodynamics data. | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | On assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993 |
|
|
|
| 0 |
| 19 |
| 3 |
| 19 |
| EG001 | 120 mg Galcanezumab | 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. | 0 | 9 | 1 | 9 |
| EG002 | 300 mg Galcanezumab | 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. | 0 | 9 | 2 | 9 |
| Application site erythema | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
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.
| D009422 | Nervous System Diseases |
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |