Phase 3
Completed N=1,382
A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7)
Migraine, Acute
Source: ClinicalTrials.gov NCT01001234 ↗
Enrolled (actual)
1,382
Serious AEs
0.2%
Results posted
May 2012
Primary outcomePrimary: Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age — 87; 63; 197; 223 participants — p=0.025
Summary
This Clinical Trial evaluates the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age |
87; 63; 197; 223 | 0.025 sig |
| SECONDARY Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age |
167; 147; 117; 139 | 0.080 |
| SECONDARY Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age |
126; 94; 256; 294 | 0.010 sig |
| SECONDARY Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age |
220; 204; 162; 184 | 0.178 |
Eligibility Criteria
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 15 headache-days per month OR has taken medication for acute
headache on more than 10 days per month in any of the 3 months prior to screening
- Patient has uncontrolled high blood pressure, uncontrolled diabetes, human immunodeficiency virus (HIV), any
cancer, or any other significant disease
- Patient has a history or clinical evidence of cardiovascular problems or stroke
- Patient has either demonstrated hypersensitivity to or experienced a serious
adverse event in response to rizatriptan
- Patient did not experience satisfactory relief from migraine pain to prior treatment with 2 or more adequate courses of 5-hydroxytryptamine 1 (5HT1) agonists
- Patient has a recent history (within the past year) or current evidence of drug or alcohol abuse or is a "recreational user" of illicit drugs
- Patient is currently taking monoamine oxidase inhibitors, methysergide, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) or propranolol, and is unable to tolerate withdrawal of these medications for the intervals required
- Patient is currently participating or has participated in a study with an
investigational compound or device within 30 days of screening
- Patient is legally or mentally incapacitated.
Data sourced from ClinicalTrials.gov (NCT01001234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.