Efficacy, Safety, and Tolerability Study 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
  50 mg 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 (50 and 100 mg) compared to placebo for the acute treatment of a single migraine attack.

Key Dates

Start date

Jul 22, 2016

Status verified

Dec 2018

Primary completion

Dec 13, 2017

Completion

Dec 14, 2017

Study Design

Enrollment

1,672 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ubrogepant 50 mg
  1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
• Experimental: Ubrogepant 100 mg
  2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
• Placebo Comparator: Placebo
  2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.

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 (90)

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