NCT05827887

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 25, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

April 13, 2023

Last Update Submit

January 1, 2026

Conditions

Migraine

Keywords

MigraineUbrogepantUbrelvyAtogepantQulipta

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Ubrogepant

Participants will receive ubrogepant as prescribed by their physician in routine clinical practice.

Atogepant

Participants will receive atogepant as prescribed by their physician in routine clinical practice.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants with migraine prescribed Ubrogepant or Atogepant by their physician.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Edith Wolfson Medical Center /ID# 269740

Holon, Central District, 5822012, Israel

Location

Maccabi Healthcare Services /ID# 254171

Kfar Saba, Central District, 4420123, Israel

Location

Meir Medical Center /ID# 254170

Kfar Saba, Central District, 4428164, Israel

Location

Shaare Zedek Medical Center /ID# 254169

Jerusalem, Jerusalem, 91031, Israel

Location

ZIV Medical Center /ID# 257360

Safed, Northern District, 13100, Israel

Location

Assuta Ashdod Medical Center /ID# 260020

Ashdod, Southern District, 7747600, Israel

Location

Soroka University Medical Center /ID# 254551

Beersheba, Southern District, 8410101, Israel

Location

The Chaim Sheba Medical Center /ID# 254550

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 263089

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Clalit HMO /ID# 257364

Gani Tikva, 5591236, Israel

Location

Hadassah Medical Center-Hebrew University /ID# 257352

Jerusalem, 91120, Israel

Location

Related Links

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2023

First Posted

April 25, 2023

Study Start

June 25, 2023

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

January 6, 2026

Record last verified: 2026-01

Locations

IL(11)