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

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ClinicalTrials.gov Identifier: NCT00617695
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : April 6, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Migraine Drug: Zolmitriptan Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
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.
Study Start Date : September 2003
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: Zolmitriptan
5mg nasal spray
Other Name: Zomig
Placebo Comparator: 2 Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Adverse Event reports [ Time Frame: Four times within 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
More Information

ClinicalTrials.gov Identifier: NCT00617695     History of Changes
Other Study ID Numbers: D1221C00005
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: April 6, 2009
Last Verified: April 2009

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

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