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

Allergan

Status and phase: Completed; Phase 3

Conditions: Migraine, With or Without Aura

Treatments: Drug: Ubrogepant; Drug: Usual Care; Drug: Placebo-matching Ubrogepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02873221

UBR-MD-04

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,254 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Completed study UBR-MD-01(NCT02828020) or UBR-MD-02(NCT02867709).

Exclusion criteria

• Patients with clinically significant electrocardiogram (ECG), vital sign, physical exam, or laboratory abnormalities
• Requirement for a medication during the study that is on the list of prohibited medications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,254 participants in 3 patient groups

Usual Care

Active Comparator group

Description:

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.

Treatment:

Drug: Usual Care

Ubrogepant 50 mg

Experimental group

Description:

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.

Treatment:

Drug: Placebo-matching Ubrogepant

Drug: Ubrogepant

Ubrogepant 100 mg

Experimental group

Description:

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.

Treatment:

Drug: Ubrogepant