Study in Participants With Acute Migraines Headaches
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Terminated
CT.gov ID
NCT00804973
Collaborator
(none)
120
19
3
5.9
6.3
1.1
Study Details
Study Description
Brief Summary
This is a Phase 2, multicenter, randomized, double-blind, placebo and active comparator-controlled study of LY2590443 in approximately 200 participants with migraines.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Safety, Tolerability, and Efficacy Study of LY2590443 in the Treatment of Acute Migraine Headache
Study Start Date
:
Nov 1, 2008
Actual Primary Completion Date
:
May 1, 2009
Actual Study Completion Date
:
May 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: LY2590443
200 milligrams (mg) as four 50-mg capsules, oral, once
Drug: Placebo injection
saline solution, injection, once
|
| Placebo Comparator: 2
|
Drug: Placebo injection
saline solution, injection, once
Drug: Placebo capsule
4 capsules, once
|
| Active Comparator: 3
|
Drug: Sumatriptan
6 milligrams (mg) injection (0.5 milliliter [mL] of 12 mg/mL solution), once
Drug: Placebo capsule
4 capsules, once
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Headache Pain Free Response [2 hours after study drug administration]
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."
Secondary Outcome Measures
- Number of Participants With Pain Free Response [30 minutes, 1 hour, 1.5 hours, 3 hours, and 4 hours after study drug administration]
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."
- Number of Participants With Pain Relief Response [30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.]
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."
- Number of Participants With Sustained Pain Relief Response [24 and 48 hours after study drug administration]
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.
- Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours [Up to 24 and 48 hours after study drug administration]
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.
- Number of Participants With Nausea [Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.]
The number of participants reporting nausea as a migraine symptom
- Number of Participants With Phonophobia [Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.]
The number of participants reporting phonophobia as a migraine symptom
- Number of Participants With Photophobia [Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.]
The number of participants reporting photophobia as a migraine symptom
- Number of Participants With Vomiting [Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.]
The number of participants reporting vomiting as a migraine symptom
- Number of Participants With Sustained Pain Free Response [24 and 48 hours after study drug administration]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Male and female participants between the ages of 18 and 65 years, inclusive.
-
Participants who have migraine headaches, with or without aura (diagnosis according the International Classification of Headache Disorders-II), for at least 1 year.
-
Participants who have had 2-8 migraine attacks on average per month for the last 3 months (but less than 15 headache days per month).
-
Participants who are willing and able to comply with the study schedule and requirements.
-
Participants who speak, read, and understand English sufficiently well and are willing to provide written informed consent.
-
Participants who in the opinion of the principal investigator are in good general health.
-
Venous access should be sufficient to allow blood sampling as per protocol.
Exclusion Criteria:
-
Participants who do not or may not tolerate 5HT1 agonist treatments, with known hypersensitivity to sumatriptan (as discussed with the investigator).
-
Female participants who have a positive pregnancy test at screening or pre- dose evaluation, or are breastfeeding.
-
History or presence of significant medical illnesses as determined by the investigator.
-
Participants with a current clinical diagnosis of major psychiatric disease.
-
Regular use of known drugs of abuse; use of opiates for migraine rescue (no more than two times per month) is permissible.
-
Blood donation of 500 milliliter (mL) or greater of whole blood products within 4 weeks of study commencement, during the study, or 4 weeks following the study.
-
Investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
-
Consumption of more than three units of alcohol per day where one unit is defined as a 12 ounces (oz) beer, 4 oz wine, or 2 oz of alcohol spirit liquor.
-
Are unwilling or unable to comply with the use of a diary to directly record data from the participant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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 | United States | 90211 |
| 2 | 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 | United States | 91910 |
| 3 | 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 | United States | 93720 |
| 4 | 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 | United States | 92845 |
| 5 | 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 | United States | 92251 |
| 6 | 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 | United States | 92123 |
| 7 | 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 | United States | 94109 |
| 8 | 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 | United States | 90404 |
| 9 | 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 | United States | 33407 |
| 10 | 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 | United States | 60625 |
| 11 | 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 | United States | 02481 |
| 12 | 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 | United States | 48104 |
| 13 | 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 | United States | 10550 |
| 14 | 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 | United States | 45069 |
| 15 | 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 | United States | 19107 |
| 16 | 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 | United States | 38119 |
| 17 | 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 | United States | 78759 |
| 18 | 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 | United States | 77004 |
| 19 | 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 | United States | 23502 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00804973
Other Study ID Numbers:
- 12258
- I2W-MC-DMAB
First Posted:
Dec 9, 2008
Last Update Posted:
May 19, 2020
Last Verified:
May 1, 2020
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | LY2590443 | Sumatriptan | Placebo |
|---|---|---|---|
| Arm/Group Description | 200 milligrams (mg) administered once as four 50-mg capsules | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution | Administered once as 4 capsules or once as an injection of saline solution |
| Period Title: Overall Study | |||
| STARTED | 40 | 40 | 40 |
| Received at Least 1 Dose of Study Drug | 40 | 40 | 40 |
| COMPLETED | 40 | 40 | 40 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | LY2590443 | Sumatriptan | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | 200 milligrams (mg) administered once as four 50-mg capsules | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution | Administered once as 4 capsules or once as an injection of saline solution | Total of all reporting groups |
| Overall Participants | 40 | 40 | 40 | 120 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
40.30
(12.40)
|
39.53
(12.94)
|
37.48
(10.58)
|
39.10
(11.98)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
28
70%
|
26
65%
|
29
72.5%
|
83
69.2%
|
| Male |
12
30%
|
14
35%
|
11
27.5%
|
37
30.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
4
10%
|
4
10%
|
7
17.5%
|
15
12.5%
|
| Not Hispanic or Latino |
36
90%
|
36
90%
|
33
82.5%
|
105
87.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
1
2.5%
|
0
0%
|
1
0.8%
|
| Asian |
0
0%
|
0
0%
|
2
5%
|
2
1.7%
|
| Native Hawaiian or Other Pacific Islander |
3
7.5%
|
3
7.5%
|
1
2.5%
|
7
5.8%
|
| Black or African American |
10
25%
|
10
25%
|
7
17.5%
|
27
22.5%
|
| White |
25
62.5%
|
24
60%
|
29
72.5%
|
78
65%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
5%
|
2
5%
|
1
2.5%
|
5
4.2%
|
| Region of Enrollment (Count of Participants) | ||||
| United States |
40
100%
|
40
100%
|
40
100%
|
120
100%
|
Outcome Measures
| Title | Number of Participants With Headache Pain Free Response |
|---|---|
| Description | 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." |
| Time Frame | 2 hours after study drug administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug. |
| Arm/Group Title | LY2590443 | Sumatriptan | Placebo |
|---|---|---|---|
| Arm/Group Description | 200 milligrams (mg) administered once as four 50-mg capsules | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution | Administered once as 4 capsules or once as an injection of saline solution |
| Measure Participants | 40 | 40 | 40 |
| Count of Participants [Participants] |
6
15%
|
12
30%
|
6
15%
|
| Title | Number of Participants With Pain Free Response |
|---|---|
| Description | 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." |
| Time Frame | 30 minutes, 1 hour, 1.5 hours, 3 hours, and 4 hours after study drug administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug. |
| Arm/Group Title | LY2590443 | Sumatriptan | Placebo |
|---|---|---|---|
| Arm/Group Description | 200 milligrams (mg) administered once as four 50-mg capsules | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution | Administered once as 4 capsules or once as an injection of saline solution |
| Measure Participants | 40 | 40 | 40 |
| 30 Minutes Post-dose |
7
17.5%
|
8
20%
|
4
10%
|
| 1 Hour Post-dose |
1
2.5%
|
5
12.5%
|
2
5%
|
| 1.5 Hours Post-dose |
3
7.5%
|
10
25%
|
5
12.5%
|
| 3 Hours Post-dose |
14
35%
|
19
47.5%
|
13
32.5%
|
| 4 Hours Post-dose |
25
62.5%
|
30
75%
|
24
60%
|
| Title | Number of Participants With Pain Relief Response |
|---|---|
| Description | 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." |
| Time Frame | 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug. |
| Arm/Group Title | LY2590443 | Sumatriptan | Placebo |
|---|---|---|---|
| Arm/Group Description | 200 milligrams (mg) administered once as four 50-mg capsules | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution | Administered once as 4 capsules or once as an injection of saline solution |
| Measure Participants | 40 | 40 | 40 |
| 30 Minutes Post-dose |
7
17.5%
|
8
20%
|
4
10%
|
| 1 Hour Post-dose |
11
27.5%
|
14
35%
|
12
30%
|
| 1.5 Hours Post-dose |
17
42.5%
|
25
62.5%
|
18
45%
|
| 2 Hours Post-dose |
22
55%
|
31
77.5%
|
24
60%
|
| 3 Hours Post-dose |
34
85%
|
35
87.5%
|
35
87.5%
|
| 4 Hours Post-dose |
38
95%
|
39
97.5%
|
34
85%
|
| Title | Number of Participants With Sustained Pain Relief Response |
|---|---|
| Description | 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. |
| Time Frame | 24 and 48 hours after study drug administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug and had Sustained Pain Relief Response data. |
| Arm/Group Title | LY2590443 | Sumatriptan | Placebo |
|---|---|---|---|
| Arm/Group Description | 200 milligrams (mg) administered once as four 50-mg capsules | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution | Administered once as 4 capsules or once as an injection of saline solution |
| Measure Participants | 22 | 31 | 24 |
| Pain Relief at 24 Hrs Post-dose |
19
47.5%
|
28
70%
|
24
60%
|
| Pain Relief at 48 Hrs Post-dose |
19
47.5%
|
27
67.5%
|
23
57.5%
|
| Title | Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours |
|---|---|
| Description | 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. |
| Time Frame | Up to 24 and 48 hours after study drug administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug with evaluable migraine recurrence data. |
| Arm/Group Title | LY2590443 | Sumatriptan | Placebo |
|---|---|---|---|
| Arm/Group Description | 200 milligrams (mg) administered once as four 50-mg capsules | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution | Administered once as 4 capsules or once as an injection of saline solution |
| Measure Participants | 39 | 39 | 39 |
| 24 Hours Post-dose |
2
5%
|
2
5%
|
4
10%
|
| 48 Hours Post-dose |
6
15%
|
4
10%
|
6
15%
|
| Title | Number of Participants With Nausea |
|---|---|
| Description | The number of participants reporting nausea as a migraine symptom |
| Time Frame | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug. |
| Arm/Group Title | LY2590443 | Sumatriptan | Placebo |
|---|---|---|---|
| Arm/Group Description | 200 milligrams (mg) administered once as four 50-mg capsules | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution | Administered once as 4 capsules or once as an injection of saline solution |
| Measure Participants | 40 | 40 | 40 |
| Pre-Dose |
18
45%
|
16
40%
|
25
62.5%
|
| 30 Minutes Post-dose |
13
32.5%
|
19
47.5%
|
19
47.5%
|
| 1 Hour Post-dose |
13
32.5%
|
13
32.5%
|
12
30%
|
| 1.5 Hours Post-dose |
8
20%
|
10
25%
|
8
20%
|
| 2 Hours Post-dose |
8
20%
|
8
20%
|
6
15%
|
| 3 Hours Post-dose |
6
15%
|
7
17.5%
|
3
7.5%
|
| 4 Hours Post-dose |
4
10%
|
4
10%
|
2
5%
|
| Title | Number of Participants With Phonophobia |
|---|---|
| Description | The number of participants reporting phonophobia as a migraine symptom |
| Time Frame | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug. |
| Arm/Group Title | LY2590443 | Sumatriptan | Placebo |
|---|---|---|---|
| Arm/Group Description | 200 milligrams (mg) administered once as four 50-mg capsules | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution | Administered once as 4 capsules or once as an injection of saline solution |
| Measure Participants | 40 | 40 | 40 |
| Pre-Dose |
28
70%
|
33
82.5%
|
31
77.5%
|
| 30 Minutes Post-dose |
24
60%
|
25
62.5%
|
26
65%
|
| 1 Hour Post-dose |
19
47.5%
|
20
50%
|
22
55%
|
| 1.5 Hours Post-dose |
15
37.5%
|
18
45%
|
16
40%
|
| 2 Hours Post-dose |
11
27.5%
|
13
32.5%
|
12
30%
|
| 3 Hours Post-dose |
6
15%
|
3
7.5%
|
5
12.5%
|
| 4 Hours Post-dose |
4
10%
|
1
2.5%
|
3
7.5%
|
| Title | Number of Participants With Photophobia |
|---|---|
| Description | The number of participants reporting photophobia as a migraine symptom |
| Time Frame | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug. |
| Arm/Group Title | LY2590443 | Sumatriptan | Placebo |
|---|---|---|---|
| Arm/Group Description | 200 milligrams (mg) administered once as four 50-mg capsules | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution | Administered once as 4 capsules or once as an injection of saline solution |
| Measure Participants | 40 | 40 | 40 |
| Pre-Dose |
38
95%
|
37
92.5%
|
38
95%
|
| 30 Minutes Post-dose |
33
82.5%
|
31
77.5%
|
36
90%
|
| 1 Hour Post-dose |
31
77.5%
|
28
70%
|
31
77.5%
|
| 1.5 Hours Post-dose |
25
62.5%
|
23
57.5%
|
27
67.5%
|
| 2 Hours Post-dose |
22
55%
|
19
47.5%
|
24
60%
|
| 3 Hours Post-dose |
12
30%
|
9
22.5%
|
10
25%
|
| 4 Hours Post-dose |
6
15%
|
4
10%
|
6
15%
|
| Title | Number of Participants With Vomiting |
|---|---|
| Description | The number of participants reporting vomiting as a migraine symptom |
| Time Frame | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug. |
| Arm/Group Title | LY2590443 | Sumatriptan | Placebo |
|---|---|---|---|
| Arm/Group Description | 200 milligrams (mg) administered once as four 50-mg capsules | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution | Administered once as 4 capsules or once as an injection of saline solution |
| Measure Participants | 40 | 40 | 40 |
| Pre-Dose |
1
2.5%
|
1
2.5%
|
2
5%
|
| 30 Minutes Post-dose |
0
0%
|
2
5%
|
1
2.5%
|
| 1 Hour Post-dose |
1
2.5%
|
1
2.5%
|
0
0%
|
| 1.5 Hours Post-dose |
1
2.5%
|
1
2.5%
|
0
0%
|
| 2 Hours Post-dose |
1
2.5%
|
0
0%
|
0
0%
|
| 3 Hours Post-dose |
0
0%
|
0
0%
|
0
0%
|
| 4 Hours Post-dose |
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Sustained Pain Free Response |
|---|---|
| Description | 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. |
| Time Frame | 24 and 48 hours after study drug administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug and had Sustained Pain Free Response data. |
| Arm/Group Title | LY2590443 | Sumatriptan | Placebo |
|---|---|---|---|
| Arm/Group Description | 200 milligrams (mg) administered once as four 50-mg capsules | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution | Administered once as 4 capsules or once as an injection of saline solution |
| Measure Participants | 6 | 12 | 6 |
| Pain Free at 24 Hours Post-dose |
5
12.5%
|
11
27.5%
|
6
15%
|
| Pain Free at 48 Hours Post-dose |
5
12.5%
|
9
22.5%
|
6
15%
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | LY2590443 | Sumatriptan | Placebo | |||
| Arm/Group Description | 200 milligrams (mg) administered once as four 50-mg capsules | 6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution | Administered once as 4 capsules or once as an injection of saline solution | |||
All Cause Mortality |
||||||
| LY2590443 | Sumatriptan | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| LY2590443 | Sumatriptan | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| LY2590443 | Sumatriptan | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/40 (32.5%) | 16/40 (40%) | 3/40 (7.5%) | |||
| Gastrointestinal disorders | ||||||
| Dry mouth | 0/40 (0%) | 0 | 2/40 (5%) | 2 | 0/40 (0%) | 0 |
| Vomiting | 0/40 (0%) | 0 | 2/40 (5%) | 3 | 0/40 (0%) | 0 |
| General disorders | ||||||
| Injection site pain | 0/40 (0%) | 0 | 2/40 (5%) | 2 | 0/40 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Muscle tightness | 0/40 (0%) | 0 | 3/40 (7.5%) | 4 | 0/40 (0%) | 0 |
| Nervous system disorders | ||||||
| Somnolence | 6/40 (15%) | 6 | 0/40 (0%) | 0 | 0/40 (0%) | 0 |
| Migraine | 5/40 (12.5%) | 5 | 0/40 (0%) | 0 | 2/40 (5%) | 2 |
| Dizziness | 2/40 (5%) | 2 | 4/40 (10%) | 4 | 1/40 (2.5%) | 1 |
| Paraesthesia | 0/40 (0%) | 0 | 4/40 (10%) | 4 | 0/40 (0%) | 0 |
| Burning sensation | 0/40 (0%) | 0 | 2/40 (5%) | 2 | 0/40 (0%) | 0 |
Limitations/Caveats
The study was terminated at the end of Part 1 (due to lack of efficacy). Part 2 was not enrolled.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00804973
Other Study ID Numbers:
- 12258
- I2W-MC-DMAB
First Posted:
Dec 9, 2008
Last Update Posted:
May 19, 2020
Last Verified:
May 1, 2020