An Observational Study to Assess Ubrogepant Tablets and Atogepant Tablets to Treat Migraine in Adult Participants

AbbVie226 enrolled

Overview

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will evaluate how effective the use of ubrogepant and atogepant is in treating adult participants with migraine. Urogepant (Ubrelvy) and Atogepant (Qulipta) are approved drugs for treatment of migraine in adults in the US. Approximately 200 adult participants who are prescribed Ubrogepant or atogepant by their doctors will be enrolled in this study in Israel. Participants will receive ubrogepant oral tablets or atogepant oral tablets as prescribed by their physician. Participants will be followed for 90 days. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Study Type

OBSERVATIONAL

Enrollment

226

Conditions

Migraine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed diagnosis of migraine according to the ICHD-3 upon judgement of the treating physician * The patients should be naive to the designated treatment * Ability to fill an e-diary app Exclusion Criteria: * Patients who cannot be treated with UBRO or ATO according to the applicable approved label * Patients participating in a concurrent clinical interventional study or within the last 30 days * Patients who were previously treated with rimegepant will be excluded from the study

Locations (11)

Edith Wolfson Medical Center /ID# 269740

Holon, Central District, Israel

Maccabi Healthcare Services /ID# 254171

Kfar Saba, Central District, Israel

Meir Medical Center /ID# 254170

Kfar Saba, Central District, Israel

Shaare Zedek Medical Center /ID# 254169

Jerusalem, Jerusalem, Israel

ZIV Medical Center /ID# 257360

Safed, Northern District, Israel

Assuta Ashdod Medical Center /ID# 260020

Ashdod, Southern District, Israel

Soroka University Medical Center /ID# 254551

Beersheba, Southern District, Israel

The Chaim Sheba Medical Center /ID# 254550

Ramat Gan, Tel Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 263089

Tel Aviv, Tel Aviv, Israel

Clalit HMO /ID# 257364

Gani Tikva, Israel

...and 1 more locations

Outcomes

Primary Outcomes

Ubrogepant (UBRO) Only: Percentage of Participants with Responder Status of "Extremely Satisfied" or "Satisfied" on a Single Item 7-Point Scale

The single item 7-point scale asks the question "Overall, how satisfied are you with Ubrelvy for treatment of your migraine?" to assess change in satisfaction of migraine treatment where 0 = extremely satisfied and 6 = extremely dissatisfied.

Time frame: Baseline to Day 90

Atogepant (ATO) Only: Percentage of Participants with Responder Status of "Extremely Satisfied" or "Satisfied" on a Single Item 7-Point Scale

The single item 7-point scale asks the question "Overall, how satisfied are you with Qulipta for treatment of your migraine?" to assess change in satisfaction of migraine treatment where 0 = extremely satisfied, 1 = satisfied and 6 = extremely dissatisfied.

Time frame: Baseline to Day 90