Trial · NCT00899379
Treatment of Multiple Attacks of Acute Migraine (0462-025)
NCT00899379, Phase 3, Completed, Organon and Co; results first posted 2010-07-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Multiple Attacks of Acute Migraine (0462-025). Trials, record NCT00899379. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00899379
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Multiple Attacks of Acute Migraine (0462-025)
- NCT number
- NCT00899379
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 473 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Migraine Headache
- Interventions
- rizatriptan benzoate, Comparator: Placebo
- First posted
- 2009-05-12
- Last updated
- 2022-02-03
- Results first posted
- 2010-07-15
- Limitations and caveats
- Pooled Extension data for PN022- NCT00897949; PN025- NCT00899379 and PN029- NCT00897104 appears in NCT00897949
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Relief at 2 Hours During the First Migraine Attack Period | 2 hours | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack |
| Secondary | Pain Relief at 2 Hours During the Second Migraine Attack Period | 2 hours | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack |
| Secondary | Pain Relief at 2 Hours During the Third Migraine Attack Period | 2 hours | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack |
| Secondary | Pain Relief at 2 Hours During the Fourth Migraine Attack Period | 2 hours | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Relief at 2 Hours During the First Migraine Attack Period | 2 hours | The primary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. | participants | NUMBER |
| SECONDARY | Pain Relief at 2 Hours During the Second Migraine Attack Period | 2 hours | The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next. | Participants | NUMBER |
| SECONDARY | Pain Relief at 2 Hours During the Third Migraine Attack Period | 2 hours | The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next. | Participants | NUMBER |
| SECONDARY | Pain Relief at 2 Hours During the Fourth Migraine Attack Period | 2 hours | The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Relief at 2 Hours During the First Migraine Attack Period | Rizatriptan 10 mg | Reporting pain relief | 246 | participants | |
| Pain Relief at 2 Hours During the First Migraine Attack Period | Placebo | Reporting pain relief | 30 | participants | |
| Pain Relief at 2 Hours During the First Migraine Attack Period | Rizatriptan 10 mg | Not reporting pain relief | 74 | participants | |
| Pain Relief at 2 Hours During the First Migraine Attack Period | Placebo | Not reporting pain relief | 52 | participants | |
| Pain Relief at 2 Hours During the Second Migraine Attack Period | Rizatriptan 10 mg | Reporting pain relief | 228 | Participants | |
| Pain Relief at 2 Hours During the Second Migraine Attack Period | Placebo | Reporting pain relief | 27 | Participants | |
| Pain Relief at 2 Hours During the Second Migraine Attack Period | Rizatriptan 10 mg | Not reporting pain relief | 63 | Participants | |
| Pain Relief at 2 Hours During the Second Migraine Attack Period | Placebo | Not reporting pain relief | 46 | Participants | |
| Pain Relief at 2 Hours During the Third Migraine Attack Period | Rizatriptan 10 mg | Reporting pain relief | 207 | Participants | |
| Pain Relief at 2 Hours During the Third Migraine Attack Period | Placebo | Reporting pain relief | 21 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo/Rizatriptan/Rizatriptan/Rizatriptan | 95 | |
| Overall Study | STARTED | Rizatriptan/Placebo/Rizatriptan/Rizatriptan | 95 | |
| Overall Study | STARTED | Rizatriptan/Rizatriptan/Placebo/Rizatriptan | 95 | |
| Overall Study | STARTED | Rizatriptan/Rizatriptan/Rizatriptan/Placebo | 94 | |
| Overall Study | STARTED | Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan | 94 | |
| Overall Study | Patients Treated | Placebo/Rizatriptan/Rizatriptan/Rizatriptan | 83 | |
| Overall Study | Patients Treated | Rizatriptan/Placebo/Rizatriptan/Rizatriptan | 82 | |
| Overall Study | Patients Treated | Rizatriptan/Rizatriptan/Placebo/Rizatriptan | 84 | |
| Overall Study | Patients Treated | Rizatriptan/Rizatriptan/Rizatriptan/Placebo | 77 | |
| Overall Study | Patients Treated | Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan | 81 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events62
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 | Asthenia/Fatigue | General disorders | Rizatriptan 10 mg | 17 | 323 | |
| other | Asthenia/Fatigue | General disorders | Placebo | 0 | 84 | |
| other | Candidiasis | Infections and infestations | Rizatriptan 10 mg | 0 | 323 | |
| other | Candidiasis | Infections and infestations | Placebo | 1 | 84 | |
| other | Chills | General disorders | Rizatriptan 10 mg | 0 | 323 | |
| other | Chills | General disorders | Placebo | 1 | 84 | |
| other | Fever | General disorders | Rizatriptan 10 mg | 1 | 323 | |
| other | Fever | General disorders | Placebo | 1 | 84 | |
| other | Pain, Abdominal | General disorders | Rizatriptan 10 mg | 5 | 323 | |
| other | Pain, Abdominal | General disorders | Placebo | 0 | 84 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rizatriptan 10 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Rizatriptan 10 mg | 199 | 323 |
| Total, other adverse events | Placebo | 31 | 84 |
| Total, serious adverse events | Rizatriptan 10 mg | 0 | 337 |
| Total, serious adverse events | Placebo | 0 | 84 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rizatriptan 10 mg vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00899379
GET https://conductscience.org/api/trials/v1/NCT00899379/flow?page=2