Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE

Inclusion Criteria

1. Parent or legal guardian is able to provide written informed consent and subject is
able to provide assent.

2. Subjects ages 6 to 11 years throughout the double-blind portion of the studyAn
established diagnosis of migraine

3. By history, average migraine frequency of ≥ 2 attacks per month lasting on average ≥ 3
hours per attack

4. By history, experiences at least 16 headache-free days per month on average

Exclusion Criteria:

1. History of ischemic or vasospastic heart disease, arrhythmias associated with
accessory conduction pathways (eg, Wolff-Parkinson-White syndrome), cerebrovascular
disease, hemiplegic or basilar artery migraine, peripheral vascular disease, ischemic
bowel disease, uncontrolled hypertension, recent (within 24 hours) or use of another
5HT1 agonist, ergots or ergotamine-containing medications.

2. Any medical condition, including severe hepatic impairment, which, in the opinion of
the investigator, may put the subject at increased risk with exposure to zolmitriptan,
or may interfere with the safety or efficacy assessments.

3. Had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist
drug (in the opinion of the investigator).

4. Had not experienced satisfactory relief from migraine pain during prior treatment with
2 or more adequate courses of triptans.

5. Prior use of any nasal spray (triptan or dihydroergotamine [DHE]) for the acute
treatment of migraine

6. Disease or anatomic abnormalities of the nasal cavity precluding or complicating the
use of ZNS.