NCT03338920

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

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of ONZETRA® Xsail® (Sumatriptan Nasal Powder) for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Currax Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating AVP-825 for the acute treatment of migraine with or without aura in adolescent subjects (12 to 17 years old).

Conditions

• Acute Migraine With or Without Aura

Interventions

Type	Name	Description
DRUG	sumatriptan nasal powder	nasal powder administered via nosepiece
DRUG	Placebo	lactose monohydrate powder administered via nosepiece

Timeline

• Start date: 2017-11-02
• Primary completion: 2022-04-11
• Completion: 2022-04-11
• First posted: 2017-11-09
• Last updated: 2023-07-24
• Results posted: 2023-07-24

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated drug study