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

Recruiting

• Conditions: Migraine

• Registration Number: NCT05827887
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-13
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-25
• Study Start: 2023-06-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (11)

Assuta Ashdod Medical Center /ID# 260020; 🇮🇱 Ashdod, HaDarom, Israel

Soroka University Medical Center /ID# 254551; 🇮🇱 Be'er Sheva, HaDarom, Israel

Edith Wolfson Medical Center /ID# 269740; 🇮🇱 Holon, HaMerkaz, Israel

Maccabi Healthcare Services /ID# 254171; 🇮🇱 Kfar Saba, HaMerkaz, Israel

Meir Medical Center /ID# 254170; 🇮🇱 Kfar Saba, HaMerkaz, Israel

ZIV Medical Center /ID# 257360; 🇮🇱 Safed, HaTsafon, 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

Shaare Zedek Medical Center /ID# 254169; 🇮🇱 Jerusalem, Yerushalayim, Israel

Clalit HMO /ID# 257364; 🇮🇱 Gani Tikva, Israel

Hadassah Medical Center-Hebrew University /ID# 257352; 🇮🇱 Jerusalem, Israel