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

ProspeCtive Observational Real-world Study of uBRogepant and Atogepant in Israel (COBRA)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05827887

Acronym

COBRA

Enrollment

226

Registered

2023-04-25

Start date

2023-06-25

Completion date

2026-01-28

Last updated

2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Migraine, Ubrogepant, Ubrelvy, Atogepant, Qulipta

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Ubrogepant (UBRO) Only: Percentage of Participants with Responder Status of "Extremely Satisfied" or "Satisfied" on a Single Item 7-Point Scale	Baseline to Day 90	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.
Atogepant (ATO) Only: Percentage of Participants with Responder Status of "Extremely Satisfied" or "Satisfied" on a Single Item 7-Point Scale	Baseline to Day 90	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.

Countries

Israel

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results