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

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

Official Title
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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

Conditions
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Migraine, With or Without Aura

Intervention / Treatment
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* Drug: Ubrogepant
* Drug: Placebo-matching Ubrogepant
* Drug: Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>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. | Drug: Usual Care<br>* Treatment for a migraine as prescribed by the physician as standard of care in clinical practice.<br>|
| Experimental: Ubrogepant 50 mg<br>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. | Drug: Ubrogepant<br>* Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.<br>Drug: Placebo-matching Ubrogepant<br>* Ubrogepant placebo-matching tablet orally for the treatment of a qualifying migraine attack.<br>|
| Experimental: Ubrogepant 100 mg<br>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. | Drug: Ubrogepant<br>* Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least 1 Treatment Emergent Adverse Event | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug. | 56 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinically Significant Laboratory Values | Hematology, Chemistry and Urinalysis results considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria. | 56 Weeks | 
| Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | ECG findings considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria. | 56 Weeks | 
| Number of Participants With Clinically Significant Vital Sign Measurements | Vital sign measurements considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria. | 56 Weeks | 
| Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales | On the C-SSRS, the 5 types of suicidal ideation are: Type 1: Wish to be dead Type 2: Non-specific active suicidal thoughts Type 3: Active suicidal ideation with any methods (not plan) without intent to act Type 4: Active suicidal ideation with some intent to act, without specific plan Type 5: Active suicidal ideation with specific plan and intent | 56 Weeks |