Phase 4 N=798 Randomized Quadruple-blind Treatment

Zomig - Treatment of Acute Migraine Headache in Adolescents

Migraine Headache

Bottom Line

View on ClinicalTrials.gov: NCT01211145 ↗

Enrolled (actual)

798

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcome: Primary: Pain-free Status at 2 Hours Post-treatment — 42; 20; 20; 68 Participants — p=.312

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Placebo (Drug); Zolmitriptan (Drug)
Age: Pediatric · 12+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain-free Status at 2 Hours Post-treatment	42; 20; 20; 68; 211; 71	.312
SECONDARY Pain-free Status at 24 Hours Post-treatment	155; 59; 60; 155; 96; 32	.575
SECONDARY Headache Response at 2 Hours Post-treatment	99; 40; 43; 116; 154; 51	.458
SECONDARY Headache Response at 24 Hours Post-treatment	170; 63; 61; 168; 81; 28	.753
SECONDARY Sustained Headache Response at 2 Hours	59; 27; 27; 66; 192; 64	.274
SECONDARY Use of Rescue Medication During the First 24 Hours After Treatment	80; 22; 18; 47; 173; 69	.153

Summary

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).

Eligibility Criteria

Inclusion Criteria

Provision of written informed consent by parent or legal guardian, and written assent provided by patient prior to any study specific procedures.
Established diagnosis of migraine.
History of a minimum of 2 migraine attacks (moderately or severely disabling)per month.

Exclusion Criteria

Any medical condition that may put the patient at increased risk with exposure to zolmitriptan or that may interfere with the safety or efficacy assessments.
A history of basilar, ophthalmoplegic, or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache.
Have had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01211145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.