Efficacy of Zolmitriptan (Zomig) in the Treatment of Migraines in Adolescents - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00617695

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 III

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Zolmitriptan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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.

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
1: Experimental	Drug: Zolmitriptan 5mg nasal spray
2: Placebo Comparator	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

No Contacts or Locations Provided

More Information

No publications provided

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

Keywords provided by AstraZeneca:

Zolmitriptan
ZOMIG
migraine

headache response
headache
headache pain

Study placed in the following topic categories:

Serotonin Agonists
Neurotransmitter Agents
Zolmitriptan
Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Pain
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Zolmitriptan
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Pharmacologic Actions
Headache Disorders
Serotonin Agents
Migraine Disorders

ClinicalTrials.gov processed this record on May 07, 2009