Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01001234 | A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7) | PHASE3 | COMPLETED | 1,382 | — | — | Nov 30, 2009 | Apr 21, 2011 | May 7, 2024 | - | — |
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.
| Arm | Type | Description |
|---|---|---|
| Stage 1: rizatriptan | EXPERIMENTAL | - |
| Stage 1: placebo | PLACEBO_COMPARATOR | - |
| Stage 2: rizatriptan | EXPERIMENTAL | - |
| Stage 2: placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| rizatriptan | DRUG | For participants randomized to rizatriptan in Stage 1: a single 5 or 10 mg rizatriptan orally disintegrating tablet (ODT) was to be taken within 30 minutes of onset of qualifying migraine (defined as a migraine of moderate or severe intensity). Rizatriptan dose administered was based on participant weight at Screening: those \<40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet. |
| placebo | DRUG | For participants randomized to placebo in Stage 1: a single placebo ODT was to be taken within 30 minutes of onset of qualifying migraine. |
Inclusion Criteria: * Patient weighs at least 20 kg (44 pounds) * Patient has had a history of migraine with or without aura \> 6 months with \>= 1 to \<= 8 moderate or severe migraine attacks per month in the 2 months prior to screening Visit 1 * Patient has a history of migraine defined by Intern...