NCT02828020

Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,672 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50 and 100 mg) compared to placebo for the acute treatment of a single migraine attack.

Conditions

• Migraine, With or Without Aura

Interventions

Type	Name	Description
DRUG	Ubrogepant	50 mg ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
DRUG	Placebo-matching Ubrogepant	Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Timeline

• Start date: 2016-07-22
• Primary completion: 2017-12-13
• Completion: 2017-12-14
• First posted: 2016-07-11
• Last updated: 2019-01-03
• Results posted: 2019-01-03

Locations

90 sites across 1 country: United States

Regulatory

• FDA-regulated drug study