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Zomig - Treatment of Acute Migraine Headache in Adolescents

NCT01211145 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1653

Last updated 2016-05-18

Study results available
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Summary

The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age 12-17 years) with migraine headaches feel better. This will be done by comparing 3 different doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).

Conditions

  • Migraine Headache

Interventions

DRUG

Placebo

Placebo nasal spray

DRUG

Zolmitriptan

0.5 mg nasal spray

DRUG

Zolmitriptan

2.5 mg nasal spray

DRUG

Zolmitriptan

5.0 mg nasal spray

Sponsors & Collaborators

Principal Investigators

  • Rohini Chitra · AZ Pharmaceuticals, US

  • Paul Winner · Children's Hospital of The King's Daughters

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States
  • Estonia
  • Finland
  • Hungary
  • Latvia
  • Poland
  • Serbia
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01211145 on ClinicalTrials.gov