Evaluating Ubrogepant and Atogepant for Migraine Treatment in Adults
ProspeCtive Observational Real-world Study of uBRogepant and Atogepant in Israel (COBRA)
This study is testing whether the medications ubrogepant and atogepant can help adults with migraines feel better over 90 days.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 11 sites (Ashdod, HaDarom and 10 other locations) |
| Trial ID | NCT05827887 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of ubrogepant and atogepant in treating migraines in adult participants. Approximately 200 adults diagnosed with migraine will be enrolled and prescribed either ubrogepant or atogepant by their physicians. Participants will be monitored over a 90-day period, attending regular visits at their healthcare facilities without any additional burden. The study will utilize an e-diary app for participants to track their migraine experiences.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a confirmed diagnosis of migraine who are naive to the treatments being evaluated.
Not a fit: Patients who cannot be treated with ubrogepant or atogepant according to the approved label will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of ubrogepant and atogepant for migraine management in adults.
How similar studies have performed: Other studies have shown positive results with similar migraine treatments, indicating that this approach is supported by prior evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ashdod, HaDarom and 10 other locations
- Assuta Ashdod Medical Center /ID# 260020 — Ashdod, HaDarom, Israel (Recruiting)
- Soroka University Medical Center /ID# 254551 — Be'er Sheva, HaDarom, Israel (Completed)
- Edith Wolfson Medical Center /ID# 269740 — Holon, HaMerkaz, Israel (Recruiting)
- Maccabi Healthcare Services /ID# 254171 — Kfar Saba, HaMerkaz, Israel (Recruiting)
- Meir Medical Center /ID# 254170 — Kfar Saba, HaMerkaz, Israel (Recruiting)
- ZIV Medical Center /ID# 257360 — Safed, HaTsafon, Israel (Recruiting)
- The Chaim Sheba Medical Center /ID# 254550 — Ramat Gan, Tel-Aviv, Israel (Recruiting)
- Tel Aviv Sourasky Medical Center /ID# 263089 — Tel Aviv, Tel-Aviv, Israel (Recruiting)
- Shaare Zedek Medical Center /ID# 254169 — Jerusalem, Yerushalayim, Israel (Recruiting)
- Clalit HMO /ID# 257364 — Gani Tikva, Israel (Recruiting)
- Hadassah Medical Center-Hebrew University /ID# 257352 — Jerusalem, Israel (Recruiting)
Study contacts
- Study coordinator: Tal Nevo
- Email: tal.nevo@abbvie.com
- Phone: +972(0)97909600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.