NCT01001234CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 1,382
- Primary Endpoint
- Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age
Study Overview
Brief Summary
This Clinical Trial evaluates the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Stage 1: rizatriptan
Experimental
Intervention: rizatriptan (Drug)
Stage 1: placebo
Placebo Comparator
Intervention: placebo (Drug)
Stage 2: rizatriptan
Experimental
Intervention: rizatriptan (Drug)
Stage 2: placebo
Placebo Comparator
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age
Time Frame: 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 Outcomes
- Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age(2 hours post Stage 2 dose)
- Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age(2 hours post Stage 2 dose)
- Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age(2 hours post Stage 2 dose)
Investigators
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