Migraine Disorders Clinical Trial
— Adelphi DSPOfficial title:
Evaluation of the Reliability of Effect of Rimegepant for the Acute Treatment of Migraine Across Multiple Attacks
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 |
Verified date | May 2024 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Pfizer | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
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 |
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