NCT02873221

An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine

A Multicenter, Randomized, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,254 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year.

Detailed description

Usual care is the open-label control arm. Dose of ubrogepant (50 mg or 100 mg) will be double-blind for active treatment arms.

Conditions

• Migraine, With or Without Aura

Interventions

Type	Name	Description
DRUG	Ubrogepant	Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
DRUG	Placebo-matching Ubrogepant	Ubrogepant placebo-matching tablet orally for the treatment of a qualifying migraine attack.
DRUG	Usual Care	Treatment for a migraine as prescribed by the physician as standard of care in clinical practice.

Timeline

• Start date: 2016-09-13
• Primary completion: 2018-08-02
• Completion: 2018-08-02
• First posted: 2016-08-19
• Last updated: 2019-08-28
• Results posted: 2019-08-28

Locations

177 sites across 1 country: United States

Regulatory

• FDA-regulated drug study