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

Phase 3

Completed

Interventions: Drug: Usual Care
Drug: Ubrogepant
Drug: Placebo-matching Ubrogepant

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Usual Care	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.
Ubrogepant 50 mg	Placebo-matching Ubrogepant	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.
Ubrogepant 50 mg	Ubrogepant	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.
Ubrogepant 100 mg	Ubrogepant	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 Measures

Name	Time	Method
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event	56 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Clinically Significant Laboratory Values	56 Weeks	Hematology, Chemistry and Urinalysis results considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings	56 Weeks	ECG findings considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Number of Participants With Clinically Significant Vital Sign Measurements	56 Weeks	Vital sign measurements considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales	56 Weeks	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"

Locations (170): Radiant Research, Inc.
🇺🇸
Dallas, Texas, United States
East Family Physicians PC/Radiant Research, Inc.
🇺🇸
Chandler, Arizona, United States
Desert Clinical Research /Radiant Research, Inc.
🇺🇸
Mesa, Arizona, United States
Xenoscience, Inc.
🇺🇸
Phoenix, Arizona, United States
Central Phoenix Medical Clinic
🇺🇸
Phoenix, Arizona, United States
Radiant Research Inc.
🇺🇸
Tucson, Arizona, United States
Orange Grove Family Practice/Radiant Research, Inc.
🇺🇸
Tucson, Arizona, United States
Principals Research Group, Inc.
🇺🇸
Hot Springs, Arkansas, United States
Arkansas Clinical Research
🇺🇸
Little Rock, Arkansas, United States
Anaheim Clinical Trials, LLC
🇺🇸
Anaheim, California, United States
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Radiant Research, Inc.
🇺🇸Dallas, Texas, United States