This study will evaluate the long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year.
Usual care is the open-label control arm. Dose of ubrogepant (50 mg or 100 mg) will be double-blind for active treatment arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,254
Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Ubrogepant placebo-matching tablet orally for the treatment of a qualifying migraine attack.
Treatment for a migraine as prescribed by the physician as standard of care in clinical practice.
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.
Time frame: 56 Weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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"
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Radiant Research, Inc.
Birmingham, Alabama, 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
...and 167 more locations
Time frame: 56 Weeks