Efficacy of Zolmitriptan (Zomig) in the Treatment of Migraines in Adolescents

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00617695
First received: February 6, 2008
Last updated: April 3, 2009
Last verified: April 2009
  Purpose

The purpose of this study is to evaluate the effectiveness and safety of Zolmitriptan (Zomig) nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches over a 3-month period in adolescent patients (aged 12 to 17 years) with migraine headaches


Condition Intervention Phase
Migraine
Drug: Zolmitriptan
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 2-Way Crossover Study With Single-Blind, Placebo-Challenge Evaluating the Efficacy of Zolmitriptan (Zomig) Nasal Spray 5mg, in the Treatment of Acute Migraine Headache in Adolescents.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Headache response and pain-free response to treatment [ Time Frame: 15 minutes, 30 minutes, 45 minutes, 1.5 hours and 2 hours after randomized treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Event reports [ Time Frame: Four times within 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 247
Study Start Date: September 2003
Study Completion Date: October 2004
Arms Assigned Interventions
Experimental: 1 Drug: Zolmitriptan
5mg nasal spray
Other Name: Zomig
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescents aged 12-17 years at the time of screening. Patients must not be enrolled if they will turn 18 years of age within 12 weeks after randomization.
  • An established diagnosis of migraine for at least 1 year; a minimum of 2 migraines, considered to be moderately/severely disabling, per month on average during the school year
  • A history of usual migraine duration of >2-hours untreated for the 3 month prior to screening

Exclusion Criteria:

  • A history of basilar, ophthalmoplegic or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache or clinically significant abnormalities indicated from the medical history, physical exam etc
  • Has used monoamine oxidase inhibitor-A (MAO-A), methysergide, methylergonovine or cimetidine in the 2 weeks before randomization.
  • Evidence of ischemic heart disease, arrhythmia, accessory conduction pathway disorder as determined by central cardiologist using predetermined and agreed upon pediatric standards; Has uncontrolled hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00617695     History of Changes
Other Study ID Numbers: D1221C00005
Study First Received: February 6, 2008
Last Updated: April 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Zolmitriptan
ZOMIG
migraine
headache response
headache
headache pain

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Oxazolidinones
Zolmitriptan
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protein Synthesis Inhibitors
Serotonin 5-HT1 Receptor Agonists
Serotonin Agents
Serotonin Receptor Agonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014