Clinical trial NCT06412965: Reliability of Rimegepant or Triptans for the Acute Treatment of Migraine
Official title: Evaluation of the Reliability of Effect of Rimegepant for the Acute Treatment of Migraine Across Multiple Attacks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-05-14
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physician personally responsible for treatment decision of migraine patients were enrolled in the survey. Each physician then enrolled consecutive patients to complete a patient self-completion questionnaire.

Brief summary: This protocol describes the analysis of the Adelphi Real World (ARW) Migraine Disease Specific Programme(TM) 2022, a cross-sectional study which used both physician and patient surveys to assess the perception of the acute treatment for migraine attacks.

Detailed description: This is a retrospective database study that aims to explore the reliability of effect with acute use of Rimegepant or triptans, to evaluate the satisfaction with Rimegepant or triptans, to evaluate willingness to continue using Rimegepant or triptans, and to explore proportion optimized on treatment with Rimegepant or triptans. The data will be extracted from the Adelphi Real World (ARW) Migraine Disease Specific ProgrammeTM (DSP) 2022 database, which was conducted across a number of countries including United States, between May 2022 and November 2022. The DSP was an observational study of clinical practice. Treatment practice data were collected by physicians (physician survey) who were asked to provide information for the next 10 patients consulting for migraine. These patients were then invited to fill out a self-completion form (patient survey) providing their own assessment on the disease and treatments.

Eligibility criteria: Inclusion criteria

* Patients who have episodic and/or chronic migraine
* Patients age \> 18
* Currently prescribed rimegepant OR triptans for the acute treatment of migraine

Exclusion criteria

* currently prescribed rimegepant for prevention of migraine or for both the acute treatment \& prevention of migraine
* Rimegepant group: currently prescribed an acute treatment for migraine and other than rimegepant
* Triptan Group: currently prescribed an acute treatment for migraine other than triptans

Primary outcomes:
measure: Number of Participants Who Failed to Achieve Pain Freedom Within 2 Hours Post Dose (Physician Perspective)
timeFrame: 2 hours post dose (from the data collected retrospectively)
measure: Number of Participants Who Reported Migraine Pain Freedom (Success) Within 2 Hours Post Dose (Participants Perspective)
timeFrame: 2 hours post dose (from the data collected retrospectively)
measure: Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Physician Perspective)
timeFrame: Over the last 3 months prior completing the survey
measure: Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Physician Perspective)
timeFrame: Over the last 3 months prior completing the survey
measure: Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Participants Perspective)
timeFrame: Over the last 3 months prior completing the survey
measure: Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Participants Perspective)
timeFrame: Over the last 3 months prior completing the survey
measure: Number of Participants Willing to Continue Use of Acute Treatment (Participants Perspective)
timeFrame: Over the last 3 months prior completing the survey
measure: Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
timeFrame: Over the last 3 months prior completing the survey
measure: Number of Participants Classified Based on Timing They Took Acute Prescription Treatment
timeFrame: Over the last 3 months prior completing the survey
measure: Mean of Number of Days Per Month Participants Took Acute Prescription Treatment
timeFrame: Over the last 3 months prior completing the survey
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: