Migraine Clinical Trial
— COBRAOfficial title:
ProspeCtive Observational Real-world Study of uBRogepant and Atogepant in Israel (COBRA)
| NCT number | NCT05827887 |
| Other study ID # | P24-078 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 25, 2023 |
| Est. completion date | September 30, 2025 |
| Verified date | April 2024 |
| Source | AbbVie |
| Contact | Tal Nevo |
| Phone | +972(0)97909600 |
| tal.nevo[@]abbvie.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | September 30, 2025 |
| Est. primary completion date | September 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Assuta Ashdod Medical Center /ID# 260020 | Ashdod | HaDarom |
| Israel | Soroka University Medical Center /ID# 254551 | Be'er Sheva | HaDarom |
| Israel | Clalit HMO /ID# 257364 | Gani Tikva | |
| Israel | Hadassah Medical Center-Hebrew University /ID# 257352 | Jerusalem | |
| Israel | Shaare Zedek Medical Center /ID# 254169 | Jerusalem | Yerushalayim |
| Israel | Maccabi Healthcare Services /ID# 254171 | Kfar Saba | HaMerkaz |
| Israel | Meir Medical Center /ID# 254170 | Kfar Saba | HaMerkaz |
| Israel | The Chaim Sheba Medical Center /ID# 254550 | Ramat Gan | Tel-Aviv |
| Israel | ZIV Medical Center /ID# 257360 | Safed | HaTsafon |
| Israel | Tel Aviv Sourasky Medical Center /ID# 263089 | Tel Aviv | Tel-Aviv |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Baseline to Day 90 | |
| Primary | 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. | Baseline to Day 90 |
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