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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,653
Pain-free Status at 2 Hours Post-treatment
Time frame: 2 hours post-treatment.
Pain-free Status at 24 Hours Post-treatment
Time frame: 24 hours post-treatment
Headache Response at 2 Hours Post-treatment
Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.
Time frame: 2 hours post-treatment
Headache Response at 24 Hours Post-treatment
Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.
Time frame: 24 hours post-treatment
Sustained Headache Response at 2 Hours
Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the patient diary. Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none a 1 hr. which is then maintained (without a return to moderate or severe pain) at 2 hrs. with no use of rescue medication prior to the 2 hr. assessment.
Time frame: Up to 2 hours post-treatment
Use of Rescue Medication During the First 24 Hours After Treatment
Time frame: 24 hours post-treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
5.0 mg nasal spray
Research Site
Phoenix, Arizona, United States
Research Site
Fresno, California, United States
Research Site
Fullerton, California, United States
Research Site
Newport Beach, California, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
Research Site
San Francisco, California, United States
Research Site
Centennial, Colorado, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Thornton, Colorado, United States
...and 64 more locations