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| ID | Type | Description | Link |
|---|---|---|---|
| I2W-MC-DMAB | Other Identifier | Eli Lilly |
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Due to efficacy results of interim analysis
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This is a Phase 2, multicenter, randomized, double-blind, placebo and active comparator-controlled study of LY2590443 in approximately 200 participants with migraines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2590443 | Drug | 200 milligrams (mg) as four 50-mg capsules, oral, once |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Headache Pain Free Response | Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate," "mild," or "none." Headache pain free response was defined as the number of participants with a migraine pain intensity score of "none." | 2 hours after study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pain Free Response | Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate", "mild," or "none." Pain free response was defined as the number of participants with a migraine pain intensity score of "none." | 30 minutes, 1 hour, 1.5 hours, 3 hours, and 4 hours after study drug administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY 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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Beverly Hills | California | 90211 |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2590443 | 200 milligrams (mg) administered once as four 50-mg capsules |
| FG001 | Sumatriptan | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Placebo injection |
| Drug |
saline solution, injection, once |
|
| Sumatriptan | Drug | 6 milligrams (mg) injection (0.5 milliliter [mL] of 12 mg/mL solution), once |
|
| Placebo capsule | Drug | 4 capsules, once |
|
| Number of Participants With Pain Relief Response | Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe", "moderate," "mild," or "none." Pain relief response was defined as the number of participants with a migraine pain intensity score of "none." | 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. |
| Number of Participants With Sustained Pain Relief Response | Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate," "mild," or "none." Sustained pain relief response was defined as the number of participants with no return of a "moderate" or "severe" headache after pain went down to "mild" or "none" at 2 hours. | 24 and 48 hours after study drug administration |
| Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours | The time to headache recurrence is presented as the number of participants experiencing at least 1 recurring headache within 24 or 48 hours of receiving study drug. | Up to 24 and 48 hours after study drug administration |
| Number of Participants With Nausea | The number of participants reporting nausea as a migraine symptom | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. |
| Number of Participants With Phonophobia | The number of participants reporting phonophobia as a migraine symptom | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. |
| Number of Participants With Photophobia | The number of participants reporting photophobia as a migraine symptom | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. |
| Number of Participants With Vomiting | The number of participants reporting vomiting as a migraine symptom | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. |
| Number of Participants With Sustained Pain Free Response | Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate," "mild," or "none. Sustained pain free response was defined as the number of participants with no return of a "mild," "moderate" or "severe" headache after pain intensity went down to "none" at 2 hours. | 24 and 48 hours after study drug administration |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chula Vista | California | 91910 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fresno | California | 93720 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Garden Grove | California | 92845 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Imperial | California | 92251 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Diego | California | 92123 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Francisco | California | 94109 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santa Monica | California | 90404 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | West Palm Beach | Florida | 33407 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chicago | Illinois | 60625 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wellesley Hills | Massachusetts | 02481 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ann Arbor | Michigan | 48104 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mount Vernon | New York | 10550 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | West Chester | Ohio | 45069 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Philadelphia | Pennsylvania | 19107 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Memphis | Tennessee | 38119 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Austin | Texas | 78759 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Houston | Texas | 77004 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Norfolk | Virginia | 23502 | United States |
| FG002 | Placebo | Administered once as 4 capsules or once as an injection of saline solution |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Participants who received at least 1 dose of study drug (LY2590443, sumatriptan, or placebo).
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2590443 | 200 milligrams (mg) administered once as four 50-mg capsules |
| BG001 | Sumatriptan | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution |
| BG002 | Placebo | Administered once as 4 capsules or once as an injection of saline solution |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
| 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 | Number of Participants With Headache Pain Free Response | Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate," "mild," or "none." Headache pain free response was defined as the number of participants with a migraine pain intensity score of "none." | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | 2 hours after study drug administration |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Pain Free Response | Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate", "mild," or "none." Pain free response was defined as the number of participants with a migraine pain intensity score of "none." | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | 30 minutes, 1 hour, 1.5 hours, 3 hours, and 4 hours after study drug administration |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Pain Relief Response | Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe", "moderate," "mild," or "none." Pain relief response was defined as the number of participants with a migraine pain intensity score of "none." | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Sustained Pain Relief Response | Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate," "mild," or "none." Sustained pain relief response was defined as the number of participants with no return of a "moderate" or "severe" headache after pain went down to "mild" or "none" at 2 hours. | All participants who received at least 1 dose of study drug and had Sustained Pain Relief Response data. | Posted | Count of Participants | Participants | No | 24 and 48 hours after study drug administration |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours | The time to headache recurrence is presented as the number of participants experiencing at least 1 recurring headache within 24 or 48 hours of receiving study drug. | All participants who received at least 1 dose of study drug with evaluable migraine recurrence data. | Posted | Count of Participants | Participants | No | Up to 24 and 48 hours after study drug administration |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Nausea | The number of participants reporting nausea as a migraine symptom | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Phonophobia | The number of participants reporting phonophobia as a migraine symptom | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Photophobia | The number of participants reporting photophobia as a migraine symptom | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Vomiting | The number of participants reporting vomiting as a migraine symptom | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Sustained Pain Free Response | Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate," "mild," or "none. Sustained pain free response was defined as the number of participants with no return of a "mild," "moderate" or "severe" headache after pain intensity went down to "none" at 2 hours. | All participants who received at least 1 dose of study drug and had Sustained Pain Free Response data. | Posted | Count of Participants | Participants | No | 24 and 48 hours after study drug administration |
|
|
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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 | LY2590443 | 200 milligrams (mg) administered once as four 50-mg capsules | 0 | 40 | 13 | 40 | ||
| EG001 | Sumatriptan | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution | 0 | 40 | 16 | 40 | ||
| EG002 | Placebo | Administered once as 4 capsules or once as an injection of saline solution | 0 | 40 | 3 | 40 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Migraine | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Burning sensation | Nervous system disorders | Systematic Assessment |
| ||
| Muscle tightness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Injection site pain | General disorders | Systematic Assessment | The Organ System includes "administration site conditions." |
|
The study was terminated at the end of Part 1 (due to lack of efficacy). Part 2 was not enrolled.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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| Participants |
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| Participants |
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