Trial Outcomes & Findings for Study in Participants With Acute Migraines Headaches (NCT NCT00804973)
NCT ID: NCT00804973
Last Updated: 2020-05-19
Results Overview
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."
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
2 hours after study drug administration
Results posted on
2020-05-19
Participant Flow
Participant milestones
| Measure |
LY2590443
200 milligrams (mg) administered once as four 50-mg capsules
|
Sumatriptan
6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
|
Placebo
Administered once as 4 capsules or once as an injection of saline solution
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study in Participants With Acute Migraines Headaches
Baseline characteristics by cohort
| Measure |
LY2590443
n=40 Participants
200 milligrams (mg) administered once as four 50-mg capsules
|
Sumatriptan
n=40 Participants
6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
|
Placebo
n=40 Participants
Administered once as 4 capsules or once as an injection of saline solution
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.30 years
STANDARD_DEVIATION 12.40 • n=5 Participants
|
39.53 years
STANDARD_DEVIATION 12.94 • n=7 Participants
|
37.48 years
STANDARD_DEVIATION 10.58 • n=5 Participants
|
39.10 years
STANDARD_DEVIATION 11.98 • n=4 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 hours after study drug administrationPopulation: All participants who received at least 1 dose of study drug.
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."
Outcome measures
| Measure |
LY2590443
n=40 Participants
200 milligrams (mg) administered once as four 50-mg capsules
|
Sumatriptan
n=40 Participants
6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
|
Placebo
n=40 Participants
Administered once as 4 capsules or once as an injection of saline solution
|
|---|---|---|---|
|
Number of Participants With Headache Pain Free Response
|
6 Participants
|
12 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 30 minutes, 1 hour, 1.5 hours, 3 hours, and 4 hours after study drug administrationPopulation: All participants who received at least 1 dose of study drug.
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."
Outcome measures
| Measure |
LY2590443
n=40 Participants
200 milligrams (mg) administered once as four 50-mg capsules
|
Sumatriptan
n=40 Participants
6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
|
Placebo
n=40 Participants
Administered once as 4 capsules or once as an injection of saline solution
|
|---|---|---|---|
|
Number of Participants With Pain Free Response
30 Minutes Post-dose
|
7 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With Pain Free Response
1 Hour Post-dose
|
1 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Pain Free Response
1.5 Hours Post-dose
|
3 Participants
|
10 Participants
|
5 Participants
|
|
Number of Participants With Pain Free Response
3 Hours Post-dose
|
14 Participants
|
19 Participants
|
13 Participants
|
|
Number of Participants With Pain Free Response
4 Hours Post-dose
|
25 Participants
|
30 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.Population: All participants who received at least 1 dose of study drug.
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."
Outcome measures
| Measure |
LY2590443
n=40 Participants
200 milligrams (mg) administered once as four 50-mg capsules
|
Sumatriptan
n=40 Participants
6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
|
Placebo
n=40 Participants
Administered once as 4 capsules or once as an injection of saline solution
|
|---|---|---|---|
|
Number of Participants With Pain Relief Response
2 Hours Post-dose
|
22 Participants
|
31 Participants
|
24 Participants
|
|
Number of Participants With Pain Relief Response
4 Hours Post-dose
|
38 Participants
|
39 Participants
|
34 Participants
|
|
Number of Participants With Pain Relief Response
30 Minutes Post-dose
|
7 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With Pain Relief Response
1 Hour Post-dose
|
11 Participants
|
14 Participants
|
12 Participants
|
|
Number of Participants With Pain Relief Response
1.5 Hours Post-dose
|
17 Participants
|
25 Participants
|
18 Participants
|
|
Number of Participants With Pain Relief Response
3 Hours Post-dose
|
34 Participants
|
35 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 24 and 48 hours after study drug administrationPopulation: All participants who received at least 1 dose of study drug and had Sustained Pain Relief Response data.
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.
Outcome measures
| Measure |
LY2590443
n=22 Participants
200 milligrams (mg) administered once as four 50-mg capsules
|
Sumatriptan
n=31 Participants
6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
|
Placebo
n=24 Participants
Administered once as 4 capsules or once as an injection of saline solution
|
|---|---|---|---|
|
Number of Participants With Sustained Pain Relief Response
Pain Relief at 24 Hrs Post-dose
|
19 Participants
|
28 Participants
|
24 Participants
|
|
Number of Participants With Sustained Pain Relief Response
Pain Relief at 48 Hrs Post-dose
|
19 Participants
|
27 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Up to 24 and 48 hours after study drug administrationPopulation: All participants who received at least 1 dose of study drug with evaluable migraine recurrence data.
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.
Outcome measures
| Measure |
LY2590443
n=39 Participants
200 milligrams (mg) administered once as four 50-mg capsules
|
Sumatriptan
n=39 Participants
6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
|
Placebo
n=39 Participants
Administered once as 4 capsules or once as an injection of saline solution
|
|---|---|---|---|
|
Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours
24 Hours Post-dose
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours
48 Hours Post-dose
|
6 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.Population: All participants who received at least 1 dose of study drug.
The number of participants reporting nausea as a migraine symptom
Outcome measures
| Measure |
LY2590443
n=40 Participants
200 milligrams (mg) administered once as four 50-mg capsules
|
Sumatriptan
n=40 Participants
6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
|
Placebo
n=40 Participants
Administered once as 4 capsules or once as an injection of saline solution
|
|---|---|---|---|
|
Number of Participants With Nausea
Pre-Dose
|
18 Participants
|
16 Participants
|
25 Participants
|
|
Number of Participants With Nausea
30 Minutes Post-dose
|
13 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants With Nausea
1 Hour Post-dose
|
13 Participants
|
13 Participants
|
12 Participants
|
|
Number of Participants With Nausea
1.5 Hours Post-dose
|
8 Participants
|
10 Participants
|
8 Participants
|
|
Number of Participants With Nausea
2 Hours Post-dose
|
8 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Nausea
3 Hours Post-dose
|
6 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Nausea
4 Hours Post-dose
|
4 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.Population: All participants who received at least 1 dose of study drug.
The number of participants reporting phonophobia as a migraine symptom
Outcome measures
| Measure |
LY2590443
n=40 Participants
200 milligrams (mg) administered once as four 50-mg capsules
|
Sumatriptan
n=40 Participants
6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
|
Placebo
n=40 Participants
Administered once as 4 capsules or once as an injection of saline solution
|
|---|---|---|---|
|
Number of Participants With Phonophobia
1 Hour Post-dose
|
19 Participants
|
20 Participants
|
22 Participants
|
|
Number of Participants With Phonophobia
1.5 Hours Post-dose
|
15 Participants
|
18 Participants
|
16 Participants
|
|
Number of Participants With Phonophobia
3 Hours Post-dose
|
6 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Phonophobia
4 Hours Post-dose
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Phonophobia
Pre-Dose
|
28 Participants
|
33 Participants
|
31 Participants
|
|
Number of Participants With Phonophobia
30 Minutes Post-dose
|
24 Participants
|
25 Participants
|
26 Participants
|
|
Number of Participants With Phonophobia
2 Hours Post-dose
|
11 Participants
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.Population: All participants who received at least 1 dose of study drug.
The number of participants reporting photophobia as a migraine symptom
Outcome measures
| Measure |
LY2590443
n=40 Participants
200 milligrams (mg) administered once as four 50-mg capsules
|
Sumatriptan
n=40 Participants
6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
|
Placebo
n=40 Participants
Administered once as 4 capsules or once as an injection of saline solution
|
|---|---|---|---|
|
Number of Participants With Photophobia
Pre-Dose
|
38 Participants
|
37 Participants
|
38 Participants
|
|
Number of Participants With Photophobia
30 Minutes Post-dose
|
33 Participants
|
31 Participants
|
36 Participants
|
|
Number of Participants With Photophobia
1 Hour Post-dose
|
31 Participants
|
28 Participants
|
31 Participants
|
|
Number of Participants With Photophobia
1.5 Hours Post-dose
|
25 Participants
|
23 Participants
|
27 Participants
|
|
Number of Participants With Photophobia
2 Hours Post-dose
|
22 Participants
|
19 Participants
|
24 Participants
|
|
Number of Participants With Photophobia
3 Hours Post-dose
|
12 Participants
|
9 Participants
|
10 Participants
|
|
Number of Participants With Photophobia
4 Hours Post-dose
|
6 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.Population: All participants who received at least 1 dose of study drug.
The number of participants reporting vomiting as a migraine symptom
Outcome measures
| Measure |
LY2590443
n=40 Participants
200 milligrams (mg) administered once as four 50-mg capsules
|
Sumatriptan
n=40 Participants
6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
|
Placebo
n=40 Participants
Administered once as 4 capsules or once as an injection of saline solution
|
|---|---|---|---|
|
Number of Participants With Vomiting
Pre-Dose
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Vomiting
30 Minutes Post-dose
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Vomiting
1 Hour Post-dose
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vomiting
1.5 Hours Post-dose
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vomiting
2 Hours Post-dose
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vomiting
3 Hours Post-dose
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vomiting
4 Hours Post-dose
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 and 48 hours after study drug administrationPopulation: All participants who received at least 1 dose of study drug and had Sustained Pain Free Response data.
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.
Outcome measures
| Measure |
LY2590443
n=6 Participants
200 milligrams (mg) administered once as four 50-mg capsules
|
Sumatriptan
n=12 Participants
6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
|
Placebo
n=6 Participants
Administered once as 4 capsules or once as an injection of saline solution
|
|---|---|---|---|
|
Number of Participants With Sustained Pain Free Response
Pain Free at 24 Hours Post-dose
|
5 Participants
|
11 Participants
|
6 Participants
|
|
Number of Participants With Sustained Pain Free Response
Pain Free at 48 Hours Post-dose
|
5 Participants
|
9 Participants
|
6 Participants
|
Adverse Events
LY2590443
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Sumatriptan
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY2590443
n=40 participants at risk
200 milligrams (mg) administered once as four 50-mg capsules
|
Sumatriptan
n=40 participants at risk
6 milligrams (mg) administered once as an injection of 0.5 milliliter (mL) of 12 mg/mL solution
|
Placebo
n=40 participants at risk
Administered once as 4 capsules or once as an injection of saline solution
|
|---|---|---|---|
|
Nervous system disorders
Somnolence
|
15.0%
6/40 • Number of events 6
|
0.00%
0/40
|
0.00%
0/40
|
|
Nervous system disorders
Migraine
|
12.5%
5/40 • Number of events 5
|
0.00%
0/40
|
5.0%
2/40 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • Number of events 2
|
10.0%
4/40 • Number of events 4
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/40
|
10.0%
4/40 • Number of events 4
|
0.00%
0/40
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/40
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/40
|
7.5%
3/40 • Number of events 4
|
0.00%
0/40
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/40
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40
|
5.0%
2/40 • Number of events 3
|
0.00%
0/40
|
|
General disorders
Injection site pain
|
0.00%
0/40
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60