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Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents

NCT03338920 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2023-07-24

Study results available
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Summary

This study will be conducted to evaluate the safety and efficacy of sumatriptan nasal powder (AVP-825) compared to placebo in the acute treatment of migraine in adolescent participants, 12 through 17 years of age.

Conditions

  • Acute Migraine With or Without Aura

Interventions

DRUG

sumatriptan nasal powder

nasal powder administered via nosepiece

DRUG

Placebo

lactose monohydrate powder administered via nosepiece

Sponsors & Collaborators

  • Currax Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Michael Kyle, MD · Currax Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-02
Primary Completion
2022-04-11
Completion
2022-04-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03338920 on ClinicalTrials.gov