Trial · NCT00804973
Study in Participants With Acute Migraines Headaches
NCT00804973, Phase 2, Terminated, Eli Lilly and Company; results first posted 2020-05-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study in Participants With Acute Migraines Headaches. Trials, record NCT00804973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00804973
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study in Participants With Acute Migraines Headaches
- NCT number
- NCT00804973
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 120 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Migraine Headache
- Interventions
- LY2590443, Placebo injection, Sumatriptan, Placebo capsule
- First posted
- 2008-12-09
- Last updated
- 2020-05-19
- Results first posted
- 2020-05-19
- Limitations and caveats
- The study was terminated at the end of Part 1 (due to lack of efficacy). Part 2 was not enrolled.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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." |
| Secondary | 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." |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Headache Pain Free Response | 2 hours after study drug administration | All participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Pain Free Response | 30 minutes, 1 hour, 1.5 hours, 3 hours, and 4 hours after study drug administration | All participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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. | All participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained Pain Relief Response | 24 and 48 hours after study drug administration | All participants who received at least 1 dose of study drug and had Sustained Pain Relief Response data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours | Up to 24 and 48 hours after study drug administration | All participants who received at least 1 dose of study drug with evaluable migraine recurrence data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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. | All participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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. | All participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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. | All participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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. | All participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained Pain Free Response | 24 and 48 hours after study drug administration | All participants who received at least 1 dose of study drug and had Sustained Pain Free Response data. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Headache Pain Free Response | LY2590443 | 6 | Participants | ||
| Number of Participants With Headache Pain Free Response | Sumatriptan | 12 | Participants | ||
| Number of Participants With Headache Pain Free Response | Placebo | 6 | Participants | ||
| Number of Participants With Pain Free Response | LY2590443 | 30 Minutes Post-dose | 7 | Participants | |
| Number of Participants With Pain Free Response | Sumatriptan | 30 Minutes Post-dose | 8 | Participants | |
| Number of Participants With Pain Free Response | Placebo | 30 Minutes Post-dose | 4 | Participants | |
| Number of Participants With Pain Free Response | LY2590443 | 1 Hour Post-dose | 1 | Participants | |
| Number of Participants With Pain Free Response | Sumatriptan | 1 Hour Post-dose | 5 | Participants | |
| Number of Participants With Pain Free Response | Placebo | 1 Hour Post-dose | 2 | Participants | |
| Number of Participants With Pain Free Response | LY2590443 | 1.5 Hours Post-dose | 3 | Participants |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LY2590443 | 40 | |
| Overall Study | STARTED | Sumatriptan | 40 | |
| Overall Study | STARTED | Placebo | 40 | |
| Overall Study | Received at Least 1 Dose of Study Drug | LY2590443 | 40 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Sumatriptan | 40 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 40 | |
| Overall Study | COMPLETED | LY2590443 | 40 | |
| Overall Study | COMPLETED | Sumatriptan | 40 | |
| Overall Study | COMPLETED | Placebo | 40 | |
| Overall Study | NOT COMPLETED | LY2590443 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events27
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Somnolence | Nervous system disorders | LY2590443 | 6 | 40 | 6 |
| other | Somnolence | Nervous system disorders | Sumatriptan | 0 | 40 | 0 |
| other | Somnolence | Nervous system disorders | Placebo | 0 | 40 | 0 |
| other | Migraine | Nervous system disorders | LY2590443 | 5 | 40 | 5 |
| other | Migraine | Nervous system disorders | Sumatriptan | 0 | 40 | 0 |
| other | Migraine | Nervous system disorders | Placebo | 2 | 40 | 2 |
| other | Dizziness | Nervous system disorders | LY2590443 | 2 | 40 | 2 |
| other | Dizziness | Nervous system disorders | Sumatriptan | 4 | 40 | 4 |
| other | Dizziness | Nervous system disorders | Placebo | 1 | 40 | 1 |
| other | Paraesthesia | Nervous system disorders | LY2590443 | 0 | 40 | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY2590443 | ||
| Total, all-cause mortality | Sumatriptan | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | LY2590443 | 13 | 40 |
| Total, other adverse events | Sumatriptan | 16 | 40 |
| Total, other adverse events | Placebo | 3 | 40 |
| Total, serious adverse events | LY2590443 | 0 | 40 |
| Total, serious adverse events | Sumatriptan | 0 | 40 |
| Total, serious adverse events | Placebo | 0 | 40 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00804973
GET https://conductscience.org/api/trials/v1/NCT00804973/results?page=2