Trial · NCT01001234
A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7)
NCT01001234, Phase 3, Completed, Organon and Co; results first posted 2012-05-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7). Trials, record NCT01001234. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01001234
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7)
- NCT number
- NCT01001234
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,382 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Migraine, Acute
- Interventions
- rizatriptan, placebo, rizatriptan, placebo
- First posted
- 2009-10-26
- Last updated
- 2024-05-07
- Results first posted
- 2012-05-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | 2 hours post Stage 2 dose | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available. |
| Secondary | Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | 2 hours post Stage 2 dose | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available. |
| Secondary | Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age | 2 hours post Stage 2 dose | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available. |
| Secondary | Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age | 2 hours post Stage 2 dose | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available. |
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 Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | 2 hours post Stage 2 dose | Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded. | participants | NUMBER |
| SECONDARY | Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | 2 hours post Stage 2 dose | Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded. | participants | NUMBER |
| SECONDARY | Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age | 2 hours post Stage 2 dose | Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded. | participants | NUMBER |
| SECONDARY | Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age | 2 hours post Stage 2 dose | Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded. | 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 Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | Rizatriptan | 2-hour pain freedom | 87 | 25.3 to 36.4 | participants |
| Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | Placebo | 2-hour pain freedom | 63 | 17.4 to 27.3 | participants |
| Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | Rizatriptan | No 2-hour pain freedom | 197 | participants | |
| Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | Placebo | No 2-hour pain freedom | 223 | participants | |
| Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | Rizatriptan | 2-hour pain relief | 167 | 52.8 to 64.6 | participants |
| Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | Placebo | 2-hour pain relief | 147 | 45.4 to 57.3 | participants |
| Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | Rizatriptan | No 2-hour pain relief | 117 | participants | |
| Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | Placebo | No 2-hour pain relief | 139 | participants | |
| Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age | Rizatriptan | 2-hour pain freedom | 126 | 28.3 to 37.9 | participants |
| Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age | Placebo | 2-hour pain freedom | 94 | 20.0 to 28.8 | 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/NA | 492 | |
| Overall Study | STARTED | Rizatriptan/NA | 31 | |
| Overall Study | STARTED | Placebo/Rizatriptan | 409 | |
| Overall Study | STARTED | Placebo/Placebo | 410 | |
| Overall Study | STARTED | Rizatriptan/Placebo | 40 | |
| Overall Study | Particpants Treated | Placebo/NA | 124 | |
| Overall Study | Particpants Treated | Rizatriptan/NA | 8 | |
| Overall Study | Particpants Treated | Placebo/Rizatriptan | 400 | |
| Overall Study | Particpants Treated | Placebo/Placebo | 405 | |
| Overall Study | Particpants Treated | Rizatriptan/Placebo | 40 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events4
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 |
|---|---|---|---|---|---|---|
| serious | Enterobacter bacteremia | Infections and infestations | Rizatriptan | 0 | 462 | 0 |
| serious | Enterobacter bacteremia | Infections and infestations | Placebo | 1 | 515 | 1 |
| serious | Migraine | Nervous system disorders | Rizatriptan | 0 | 462 | 0 |
| serious | Migraine | Nervous system disorders | Placebo | 1 | 515 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rizatriptan | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Rizatriptan | 0 | 462 |
| Total, other adverse events | Placebo | 0 | 515 |
| Total, serious adverse events | Rizatriptan | 0 | 462 |
| Total, serious adverse events | Placebo | 2 | 515 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22711898 | DERIVED |
Source PubMed
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 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/NCT01001234
GET https://conductscience.org/api/trials/v1/NCT01001234/flow?page=2