MedTrace Logo

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

NCT01001234 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1382

Last updated 2024-05-07

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Migraine, Acute

Interventions

DRUG

rizatriptan

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.

DRUG

placebo

For participants randomized to placebo in Stage 1: a single placebo ODT was to be taken within 30 minutes of onset of qualifying migraine.

DRUG

rizatriptan

For participants randomized to rizatriptan in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder \[moderate or severe pain 15 minutes after dose\] to be randomized at Stage 2): a single 5 or 10 mg rizatriptan ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Rizatriptan dose administered was based on participant weight at Screening: those \<40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet.

DRUG

placebo

For participants randomized to placebo in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder to be randomized at Stage 2) or allocated to placebo in Stage 2 (took rizatriptan in Stage 1 and was Non-Responder): a single placebo ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-04-21
Completion
2011-04-21

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01001234 on ClinicalTrials.gov