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

• Placebo ZNS (Drug), also known as Placebo: Placebo Zolmitriptan Nasal Spray
• ZNS (Drug): Zolmitriptan Nasal Spray

Primary outcomes

• Pain-free status at 2 hours post treatment [2 hours post-dose]: Headache pain intensity is assessed by the subjects immediately prior to treatment and 2 hours post-dose using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0).

Secondary outcomes

• Proportion of subjects who achieve pain-free status at 24 hours post-dose [24 hours post-dose]: The headache pain intensity is assessed by the subjects using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0).
• Headache response at 24 hours post-dose [24 hours post-dose]: The subject diary captures the headache severity using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0). Headache response is defined as a reduction in moderate (2) or severe (3) pain to mild (1) or no (0) pain at 24 hour post-dose.
• Sustained headache response at 24 hours post-dose [24 hours post-dose]: Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none at 2 hours which is then maintained (without a return to moderate or severe pain) at 24 hours with no use of rescue medication prior to the 24 hour assessment.

Sex: All, ages: 6 Years to 11 Years

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.

• Impax Study Director, Study director, Impax Laboratories, LLC