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

Conditions

• Migraine, With or Without Aura

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Ubrogepant — DRUG
  Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
• Placebo-matching Ubrogepant — DRUG
  Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Study Details

This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.

Key Dates

Start date

Aug 26, 2016

Status verified

Mar 2019

Primary completion

Jan 25, 2018

Completion

Feb 26, 2018

Study Design

Enrollment

1,686 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ubrogepant 25 mg
  1 ubrogepant 25 milligram (mg) tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
• Experimental: Ubrogepant 50 mg
  1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
• Placebo Comparator: Placebo
  1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.

Primary Outcome Measure

Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose [ Time Frame: Baseline (Predose) to 2 hours after initial dose ]

Locations (109)

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