Status:
COMPLETED
Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE
Lead Sponsor:
Impax Laboratories, LLC
Collaborating Sponsors:
AstraZeneca
Conditions:
Migraine
Eligibility:
All Genders
6-11 years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment of migraine headache in subjects ages 6 to 11 years. Part 1: Approximately 20 weeks (includes screening an...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Parent or legal guardian is able to provide written informed consent and subject is able to provide assent.
- Subjects ages 6 to 11 years throughout the double-blind portion of the studyAn established diagnosis of migraine
- By history, average migraine frequency of ≥ 2 attacks per month lasting on average ≥ 3 hours per attack
- By history, experiences at least 16 headache-free days per month on average
- Exclusion Criteria:
- 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.
- 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.
- Had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug (in the opinion of the investigator).
- Had not experienced satisfactory relief from migraine pain during prior treatment with 2 or more adequate courses of triptans.
- Prior use of any nasal spray (triptan or dihydroergotamine \[DHE\]) for the acute treatment of migraine
- Disease or anatomic abnormalities of the nasal cavity precluding or complicating the use of ZNS.
Exclusion
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2020
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT03275922
Start Date
November 27 2017
End Date
September 28 2020
Last Update
January 11 2021
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