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

Conditions

• Migraine, With or Without Aura

Eligibility Criteria

Sex

ALL

Age

18 Years - 76 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Sep 13, 2016

Status verified

Aug 2019

Primary completion

Aug 2, 2018

Completion

Aug 2, 2018

Study Design

Enrollment

1,254 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Usual Care
  Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
• Experimental: Ubrogepant 50 mg
  Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
• Experimental: Ubrogepant 100 mg
  Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.

Primary Outcome Measure

Percentage of Participants With at Least 1 Treatment Emergent Adverse Event [ Time Frame: 56 Weeks ]

Locations (177)

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