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OpenTrials
Completed

NCT Number: NCT03275922

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Phoenix Children's Hospital (149), Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo ZNS

Drug

Placebo Zolmitriptan Nasal Spray

Other names: Placebo

ZNS

Drug

Zolmitriptan Nasal Spray

Primary outcomes

  1. Pain-free status at 2 hours post treatment

    Time frame: 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

  1. Proportion of subjects who achieve pain-free status at 24 hours post-dose

    Time frame: 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).

  2. Headache response at 24 hours post-dose

    Time frame: 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.

  3. Sustained headache response at 24 hours post-dose

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Impax Laboratories, LLC

Industry

Collaborators

  • AstraZeneca

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Evaluate The Efficacy And Safety Of Zolmitriptan Nasal Spray For The Treatment Of Acute Migraine In Subjects Ages 6 To 11 Years, With An Open-Label Extension

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 8, 2017
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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