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

Impax Laboratories

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: ZNS; Drug: Placebo ZNS

Study type: Interventional

Funder types: Industry

Identifiers

NCT03275922

IPX229-B16-01

Details and patient eligibility

About

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 and double-blind treatment).

• Screening will be performed based on the inclusion exclusion criteria specified in the study protocol.
• Randomize approximately 288 subjects into the double-blind crossover phase.

Part 2: Approximately 100 subjects who complete the double-blind crossover phase will enter part 2, a 6 month open-label safety extension (OLE).

Efficacy will be evaluated in the double-blind part of the trial. Safety will be evaluated in both the double-blind and the OLE.

Enrollment: 374 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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374 participants in 2 patient groups

Run-in - ZNS - Placebo - OLE

Other group

Description:

After Run-in period, subjects will be randomized to ZNS followed by placebo ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2).

Treatment:

Drug: ZNS

Drug: Placebo ZNS

Run-in - Placebo - ZNS - OLE

Other group

Description:

After Run-in period, subjects will be randomized to placebo ZNS followed by ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2).

Treatment:

Drug: ZNS

Drug: Placebo ZNS