Trial · NCT01004263
A Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3)
NCT01004263, Phase 3, Completed, Organon and Co; results first posted 2012-05-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3). Trials, record NCT01004263. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01004263
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3)
- NCT number
- NCT01004263
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 674 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Acute Migraine With or Without Aura in Adolescents
- Interventions
- rizatriptan benzoate
- First posted
- 2009-10-29
- Last updated
- 2024-04-22
- Results first posted
- 2012-05-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) Within 24 Hours Post Any Dose | Up to 24 hours post dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. Participants with an AE occurring within 24 hours after any dose administered during the study are counted once in this summary. |
| Primary | Number of Participants With AEs Within 14 Days Post Any Dose | Up to 14 days post dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. AEs were assessed in a phone contact 14 days after the last dose of study medication. Participants with an AE occurring within 14 days after any dose administered during the study are counted once in this summary. |
| Primary | Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose | Up to 24 hours post dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 24 hours post dose are counted in this summary. |
| Primary | Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose | Up to 14 days post dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 14 days post dose are counted in this summary. |
| Secondary | Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose | 2 hours post dose | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom (PF) was defined as a reduction in severity from a rating of 5, 4, 3 or 2 (mild, moderate or severe pain) before the dose to a rating of 1 (no pain) at 2 hours after dosing. Pain intensity ratings were reported in diaries returned at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. PF at 2 hours was summarized as follows: the percentage of treated attacks with PF at 2 hours was calculated for each patient first, then the mean across all patients was calculated. |
Source ClinicalTrials.gov
Outcomes5
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 Adverse Events (AEs) Within 24 Hours Post Any Dose | Up to 24 hours post dose | All enrolled participants who administered at least one dose of study medication | participants | NUMBER |
| PRIMARY | Number of Participants With AEs Within 14 Days Post Any Dose | Up to 14 days post dose | All enrolled participants who administered at least one dose of study medication | participants | NUMBER |
| SECONDARY | Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose | 2 hours post dose | All participants who were enrolled and reported at least one treated migraine attack with at least one post treatment efficacy evaluation | percentage of participant's attacks | MEAN |
| PRIMARY | Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose | Up to 24 hours post dose | All enrolled participants who administered at least one dose of study medication | participants | NUMBER |
| PRIMARY | Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose | Up to 14 days post dose | All enrolled participants who administered at least one dose of study medication | participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
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 Adverse Events (AEs) Within 24 Hours Post Any Dose | Rizatriptan | 322 | participants | ||
| Number of Participants With AEs Within 14 Days Post Any Dose | Rizatriptan | 400 | participants | ||
| Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose | Rizatriptan | 46.3 | Standard Deviation 31.9 | percentage of participant's attacks | |
| Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose | Rizatriptan | 4 | participants | ||
| Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose | Rizatriptan | 14 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rizatriptan | 606 | |
| Overall Study | COMPLETED | Rizatriptan | 427 | |
| Overall Study | NOT COMPLETED | Rizatriptan | 179 |
Source ClinicalTrials.gov
Adverse events25
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 | Nausea | Gastrointestinal disorders | Rizatriptan | 40 | 606 | 77 |
| other | Fatigue | General disorders | Rizatriptan | 33 | 606 | 111 |
| other | Nasopharyngitis | Infections and infestations | Rizatriptan | 47 | 606 | 56 |
| other | Upper respiratory tract infection | Infections and infestations | Rizatriptan | 31 | 606 | 33 |
| other | Accidental overdose | Injury, poisoning and procedural complications | Rizatriptan | 148 | 606 | 216 |
| other | Dizziness | Nervous system disorders | Rizatriptan | 52 | 606 | 94 |
| other | Somnolence | Nervous system disorders | Rizatriptan | 44 | 606 | 123 |
| serious | Sinus bradycardia | Cardiac disorders | Rizatriptan | 1 | 606 | 1 |
| serious | Abdominal discomfort | Gastrointestinal disorders | Rizatriptan | 2 | 606 | 2 |
| serious | Fatigue | General disorders | Rizatriptan | 1 | 606 | 2 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rizatriptan | ||
| Total, other adverse events | Rizatriptan | 284 | 606 |
| Total, serious adverse events | Rizatriptan | 22 | 606 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23078588 | 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 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/NCT01004263
GET https://conductscience.org/api/trials/v1/NCT01004263/events?page=2