Back to resultsEfficacy of Zolmitriptan (Zomig) in the Treatment of Migraines in Adolescents
Primary Purpose
Migraine
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Zolmitriptan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Zolmitriptan, ZOMIG, migraine, headache response, headache, headache pain
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Headache response and pain-free response to treatment
Secondary Outcome Measures
Adverse Event reports
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00617695
Brief Title
Efficacy of Zolmitriptan (Zomig) in the Treatment of Migraines in Adolescents
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 Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Zolmitriptan, ZOMIG, migraine, headache response, headache, headache pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
247 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Zolmitriptan
Other Intervention Name(s)
Zomig
Intervention Description
5mg nasal spray
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Adverse Event reports
Time Frame
Four times within 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Zolmitriptan (Zomig) in the Treatment of Migraines in Adolescents
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