Clinical 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)
Official title: A Worldwide, Randomized, Double Blind, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine, Acute
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-10-26
Enrollment: 1382
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Clinical Trial evaluates the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents.


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 \<= 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 International Headache Society (IHS) migraine definitions
* Patient is willing to stay awake for at least 2 hours after administration of the first dose of study medication
* Patient has not experienced satisfactory relief from migraine pain with nonsteroidal anti-inflammatory drugs (NSAIDs) or N-acetyl-p-aminophenol (APAP) treatment
* The parent or guardian and patient agree to the patient's participation in the study as indicated by parental/guardian signature on the consent form and

patient assent

- For patients taking migraine prophylactic medication, treatment regimen is stable and has been taken for at least 3 months prior to Visit 1.

Exclusion Criteria:

* Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation
* Patient has a history of mild migraine attacks or migraines that resolve in less than 2 hours
* Patient has basilar or hemiplegic migraine headaches
* Patient has \>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.

Primary outcomes:
measure: Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age
timeFrame: 2 hours post Stage 2 dose
Secondary outcomes:
measure: Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age
timeFrame: 2 hours post Stage 2 dose
measure: Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age
timeFrame: 2 hours post Stage 2 dose
measure: Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age
timeFrame: 2 hours post Stage 2 dose
Other outcomes:
Locations:
Study officials:
References:
citation: Ho TW, Pearlman E, Lewis D, Hamalainen M, Connor K, Michelson D, Zhang Y, Assaid C, Mozley LH, Strickler N, Bachman R, Mahoney E, Lines C, Hewitt DJ; Rizatriptan Protocol 082 Pediatric Migraine Study Group. Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design. Cephalalgia. 2012 Jul;32(10):750-65. doi: 10.1177/0333102412451358. Epub 2012 Jun 18.