A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7)

NCT01001234 | Completed Phase 3 Results DMC

• 3 other identifiers: 0462-0822009_679CTRI/2010/091/000407
• Study Type: interventional
• Target: 1,382
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Migraine, Acute

Outcome Measures

Primary Outcomes (1)

• Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age

  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.

  2 hours post Stage 2 dose

Secondary Outcomes (3)

• 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

• Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age

  2 hours post Stage 2 dose

Study Arms (4)

Stage 1: rizatriptan

EXPERIMENTAL

Drug: rizatriptan

Stage 1: placebo

PLACEBO COMPARATOR

Drug: placebo

Stage 2: rizatriptan

EXPERIMENTAL

Drug: rizatriptan

Stage 2: placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

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.

Also known as: Maxalt, MK-0462

Stage 1: rizatriptan

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.

Stage 1: placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 22711898 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

rizatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 26, 2009
• Study Start: November 30, 2009
• Primary Completion: April 21, 2011
• Study Completion: April 21, 2011
• Last Updated: May 7, 2024
• Results First Posted: May 8, 2012

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share