Clinical trial NCT05827887: An Observational Study to Assess Ubrogepant Tablets and Atogepant Tablets to Treat Migraine in Adult Participants
Official title: ProspeCtive Observational Real-world Study of uBRogepant and Atogepant in Israel (COBRA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Keywords: Migraine
Ubrogepant
Ubrelvy
Atogepant
Qulipta
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-04-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with migraine prescribed Ubrogepant or Atogepant by their physician.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ubrogepant (UBRO) Only: Percentage of Participants with Responder Status of "Extremely Satisfied" or "Satisfied" on a Single Item 7-Point Scale
timeFrame: Baseline to Day 90
measure: Atogepant (ATO) Only: Percentage of Participants with Responder Status of "Extremely Satisfied" or "Satisfied" on a Single Item 7-Point Scale
timeFrame: Baseline to Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Ashdod
country: Israel
facility: Assuta Ashdod Medical Center /ID# 260020
state: HaDarom
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center /ID# 254551
state: HaDarom
city: Holon
country: Israel
facility: Edith Wolfson Medical Center /ID# 269740
state: HaMerkaz
city: Kfar Saba
country: Israel
facility: Maccabi Healthcare Services /ID# 254171
state: HaMerkaz
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 254170
state: HaMerkaz
city: Safed
country: Israel
facility: ZIV Medical Center /ID# 257360
state: HaTsafon
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 254550
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 263089
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 254169
state: Yerushalayim
city: Gani Tikva
country: Israel
facility: Clalit HMO /ID# 257364
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 257352
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: