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MigraineCONFIDENCENCT06467370

A Real-world, Prospective Observational Study of Rimegepant ODT for the Acute Treatment of Migraine Attacks in Adults.

An observational study of Migraine, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims at characterizing the effectiveness of rimegepant as an acute migraine treatment in a real world setting on two aspects: Consistency of response to rimegepant across multiple attacks Effectiveness of rimegepant in users taking concomitant migraine preventive medications, namely monoclonal antibodies… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine
How many people
467 participants
Where
1 siteUnited States
Study dates
2 Jul 2024to 11 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: There are 4 subpopulations in this study: 1. participants using rimegepant and no prophylactic 2. participants using rimegepant with background prophylaxis of OMPM 3. participants using rimegepant with background prophylaxis of mAbs 4. participants using rimegepant with background prophylaxis of Botox.

Who may be able to join

  • Female or male patients with migraine ≥18 years old
  • Having received a prescription for rimegepant for acute treatment
  • Experienced between 3 and 14 Headache days in the last 30 days
  • Planning to use rimegepant for attacks happening during the next 30 days

Who cannot join

  • Report currently using rimegepant as preventive
  • Report currently using concomitantly onabotulinumtoxin and any of the mAbs
  • Currently participating in a Migraine-related clinical trial
  • Reports a diagnosis from a doctor or other health professional of cluster headache, post-traumatic headache, new daily persistent headache, or hemicrania continua

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pfizer

    New York, New York, 10001

Other trials in United States

About this study

Official title: CONFIDENCE: A PROSPECTIVE OBSERVATIONAL STUDY WITH ACUTE TREATMENT OF RIMEGEPANT ODT ON CONSISTENCY, SATISFACTION AND TOLERABILITY OF TREATMENT IN THE REAL WORLD

This study aims at characterizing the effectiveness of rimegepant as an acute migraine treatment in a real world setting on two aspects:

  • Consistency of response to rimegepant across multiple attacks
  • Effectiveness of rimegepant in users taking concomitant migraine preventive medications, namely monoclonal antibodies targeting CGRP and onabotulinumtoxinA
Read the detailed description

This study will be conducted in a real-world setting in the US using a bespoke interface contained in the Migraine Buddy mobile application. Participants who report using rimegepant for the acute treatment of migraine will be recruited and will be asked to complete a series of questionnaires during the screening and study period. Patient reported outcome measures will be collected at study enrollment, daily during the 28-day observation period, and at the end of the study period.

Research Questions:

  1. In adult patients currently receiving a prescription for rimegepant for the acute treatment of migraine, what is the population-level consistency of rimegepant response for pain reduction, meaningful pain relief, performance in daily activities, and return to normal function across multiple attacks in a real-world setting, regardless of prophylactic background?
  2. What is the satisfaction level of patients receiving rimegepant on background migraine prophylaxis (specifically, anti-CGRP mAbs or onabotulinumtoxinA (Botox)?
  3. What is the efficacy, safety, and tolerability of rimegepant for the acute treatment of migraine, when taken in combination with preventive medications that act on the same pathway?
Conditions
Migraine
Keywords
rimegepant, acute migraine treatment, real-world setting
Medical subject headings
Migraine Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Satisfaction with prescribed medication

    Satisfaction with prescribed medication (rimegepant-treated attacks) as measured by 5 questions with a 7-point rating scale; Distribution analysis and Responder Yes/No. Responder definition: Extremely Satisfied, Satisfied, Slightly Satisfied."

    Measured: Day 30

  2. Population level consistency

    Population level consistency will be determined utilizing the daily diary item 'meaningful pain relief' when rimegepant is used to acutely treat a migraine attack. Those who report meaningful pain relief at <1 or 1-2 hours after taking rimegepant will be considered a 'responder'. Those who report meaningful pain relief >2 hours or those who did not achieve meaningful relief/used another acute treatment since taking rimegepant will be considered 'delayed responder' or 'non-responder,' respectively. Population level consistency will be evaluated as the proportion of responders for each attack treated with rimegepant.

    Measured: Day 30

  3. Assessments of meaningful clinical effect

    Assessments of meaningful clinical effect will be measured by the rates in achieving meaningful pain relief at other timepoints, rates of improvement of migraine severity and functional disability, satisfaction with treatment and rates of acute treatment optimization. Responder definition: Improvement in functional disability 2 hours after taking rimegepant vs at time of intake (reduction by at least 1 category:e.g., from severely impaired to moderately impaired, from moderately impaired to mildly impaired, from mildly impaired to no disability).

    Measured: Day 30

  4. meaningful improvement in functioning

    Experience of "meaningful improvement in functioning" between 1 and 4 hours after intake.

    Measured: Day 30

Secondary outcomes (1)

  1. Effectiveness of rimegepant in users taking concomitant migraine preventive medications

    Percentage of Participants Achieving Meaningful Pain Relief Meaningful relief occurs when the level of headache pain has been reduced to a degree that is meaningful to the participant; this can, but does not necessarily, occur prior to pain freedom. Participants will provide responses for rimegepant-treated migraine attacks about the time to achieve meaningful relief of headache pain. This will result in a binary responder definition coded as "yes" for those achieving meaningful pain relief or "no" for those not satisfying that definition.

    Percentage of Participants Who Experience Meaningful improvement in functioning Participants will also rate the ability to perform daily activities at the point when rimegepant was taken using the Functional Disability Scale. This will result in a binary responder definition coded as "yes" for those achieving return to normal function or "no" for those not satisfying that definition.

    Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2024
  2. Study start2 Jul 2024
  3. Primary completion11 Mar 2025
  4. Study completion11 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
467 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06467370
Sponsor's protocol ID
C4951072
Other IDs
AUDACITY
Acronym
CONFIDENCE
Status last verified
May 2026
First submitted
14 Jun 2024
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Lipton RB, Goadsby PJ, Pozo-Rosich P, Urani A, Lambru G, Schwedt TJ, Fanning KM, Bostic RC, Dai F, Abraham L, Hygge Blakeman K. Effectiveness of Rimegepant for the Acute Treatment of Migraine Among Participants Using Different Types of Preventive Therapy: Analyses from CONFIDENCE. Neurol Ther. 2026 Sep 9. doi: 10.1007/s40120-026-01024-9. Online ahead of print.

    PubMed 42717153

  • Lipton RB, Abraham L, Urani A, Lambru G, Goadsby PJ, Pozo-Rosich P, Schwedt TJ, Fanning KM, Dai F, Blakeman KH. Consistency of response to rimegepant for the acute treatment of migraine among real-world users - findings from the prospective observational CONFIDENCE study. J Headache Pain. 2026 Jun 12;27(1):200. doi: 10.1186/s10194-026-02421-z.

    PubMed 42286469

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Satisfaction with prescribed medication (time frame: Day 30). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06467370, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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