Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06412965
Other study ID # C4951066
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2024
Est. completion date January 3, 2024

Study information

Verified date May 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

This is a retrospective database study that aims to explore the reliability of effect with acute use of Rimegepant, to evaluate the satisfaction with Rimegepant, to evaluate willingness to continue using Rimegepant, and to explore proportion optimized on treatment with Rimegepant. 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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date January 3, 2024
Est. primary completion date January 3, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria - Patients who have episodic and/or chronic migraine - Patients age > 18 - Currently prescribed rimegepant for the acute treatment of migraine Exclusion criteria - currently prescribed rimegepant for prevention of migraine or for both the acute treatment & prevention of migraine - Currently prescribed an acute treatment for migraine other than rimegepant

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Pfizer New York New York

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Failure to achieve pain freedom within 2 hours post dose (physician perspective) Frequency of patients for which the physician reports that fail to achieve pain freedom at 2 hours post dose on more than half of occasions measured by using answers on the physician survey 2 hours post dose
Primary Number of migraine attacks acute treatment achieves pain freedom within 2 hours post dose (patient perspective) Frequency of patients who reported migraine pain freedom within 2 hours post dosing in 0 out of every 5 attacks, 1 out of every 5 attacks, 2 out of every 5 attacks, 3 out of every 5 attacks, 4 out of every 5 attacks, or 5 out of every 5 attacks measured by using answers on the patient survey 2 hours post dose
Primary Reason for choice of current acute treatment - 'consistency of response after repeated use' (physician perspective) Description of the reasons why the physician chooses the acute treatment considering the following domains: type of control and effects; formulation/dosage; quality of life; side effects and safety; patient types; and general attributes measured by using answers on the physician survey Over the last 3 months prior completing the survey
Primary Satisfaction with current acute treatment (physician perspective) Frequency with which the physician is extremely satisfied, satisfied, slightly satisfied, neither satisfied not dissatisfied, slightly dissatisfied, or extremely dissatisfied with the patient´s acute treatment prescription measured by using answers on the physician survey Over the last 3 months prior completing the survey
Primary Drivers for lack of satisfaction with current acute treatment (physician perspective) Description of the reasons why the physician is not satisfied with patient´s treatment prescription measured by using answers on the physician survey Over the last 3 months prior completing the survey
Primary Satisfaction with current acute treatment (patient perspective) Frequency of patients who reported being extremely satisfied, satisfied, slightly satisfied, neither satisfied not dissatisfied, slightly dissatisfied, or extremely dissatisfied with the treatment for their migraine attacks measured by using answers on the patient survey Over the last 3 months prior completing the survey
Primary Drivers for lack of satisfaction with current acute treatment (patient perspective) Description of the reasons why the patients are not satisfied or extremely satisfied with their acute treatment measured by using answers on the patient survey Over the last 3 months prior completing the survey
Primary Patient willingness to continue use of acute treatment (patient perspective) Frequency of patients who reported willingness to continue using their acute treatment, categorized into definitely yes, probably yes, do not know, probably not, or definitely not measured by using answers on the patient survey Over the last 3 months prior completing the survey
Primary Migraine treatment optimization questionnaire (mTOQ6) Mean and median of total scores. The mTOQ-6 score is calculated by summing individual question scores (score range of 6-24), with higher scores indicating better acute treatment optimization Over the last 3 months prior completing the survey
Primary Migraine Treatment Optimization Questionnaire (m-TOQ6) Frequency of each item with the response options (never, rarely, less than half of the time, or half of the time or more) Over the last 3 months prior completing the survey
Primary When patients takes acute prescription treatment Frequency of patients who usually take their acute treatment: before any sign of a migraine attack, but in anticipation of one starting; or at the first sign of a migraine attack (before the pain starts); or when the pain starts; or after the pain has started and have an idea of how severe it is measured by using answers on the patient survey Over the last 3 months prior completing the survey
Primary How many days per month patient takes acute prescription treatment Average number of days per month the patient takes the acute treatment measured by using answers on the patient survey Over the last 3 months prior completing the survey
See also
  Status Clinical Trial Phase
Completed NCT01432379 - BOTOX® Prophylaxis in Patients With Chronic Migraine
Completed NCT04084314 - Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study Phase 4
Recruiting NCT05048914 - Migraine Abortive Treatment
Completed NCT03662295 - Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention
Completed NCT02766517 - Biomarker Study in Participants With Migraine Early Phase 1
Completed NCT00963937 - Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents Phase 3
Not yet recruiting NCT03632928 - Day to Day Variation of Pressure Pain Threshold and Muscle Hardness
Completed NCT02559895 - A Multicenter Assessment of ALD403 in Frequent Episodic Migraine Phase 3
Completed NCT01435941 - Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine N/A
Completed NCT00743015 - Relative Bioavailability of a Single Dose of BI 44370 Tablet During and Between Migraine Attacks Phase 1
Completed NCT01376141 - Drug Use Investigation for IMIGRAN Tablet N/A
Completed NCT02183688 - Acetylsalicylic Acid (ASA) + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients Phase 3
Completed NCT06061588 - "Potential Effects of Virtual Reality Technology on the Treatment of Migraine-Type Headaches" N/A
Completed NCT03588364 - The Role of Osteopathic Manipulation in the the Management of Post-traumatic Migraine N/A
Completed NCT04091321 - Association Between Chronic Headache and Back Pain With Childbirth
Completed NCT00385008 - TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine Phase 3
Active, not recruiting NCT05888298 - Proximal and Distal Approach GON RFT in Migraine N/A
Completed NCT03435185 - Greater Occipital and Supraorbital Nerve Blockade in Migraine Patients N/A
Recruiting NCT06459635 - Migraine Attack Pain Phase Prediction Study
Completed NCT02565186 - An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine Phase 3