Trial · NCT06680206
Registered outcomes53
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 53
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants According to Migraine Medication Type (Prescription Drug or Over the Counter [OTC]) | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | Number of participants according to migraine medication type: 1) as prescription drug only, 2) as OTC only or 3) as both prescription drug and OTC based on the use of migraine medication classes is reported in this outcome measure. Analysis was performed using inverse probability treatment weighting (IPTW) method to adjust for confounding by the covariates. |
| Primary | Number of Participants According to Migraine Treatment Type (Acute or Prevention) | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | Number of participants according to migraine treatment type: 1) acute use only, 2) prevention use only, or 3) both acute and prevention use based on the use of migraine medication classes is reported in this outcome measure. Acute treatments included: triptans, non-steroidal anti-inflammatory drugs (NSAIDs), opioids, barbiturates, ergots, gepants \[acute; including Nurtec\], ditan, combination analgesics, and other acute treatment; preventive treatment included: anticonvulsants, beta blocker, antidepressant, calcitonin gene-related peptide antibodies monoclonal antibodies (CGRP mAb), botox, and gepant \[prevention treatment including Nurtec\]). Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | Total Number of Acute Migraine Agent Drug Classes Used | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | Total number of distinct acute migraine agent drug classes used by participants is reported as mean in this outcome measure. Acute migraine agents included: triptans, NSAIDs, opioids, barbiturates, ergots, gepants \[acute; including Nurtec\], ditan, combination analgesics, and other acute treatment. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | Number of Participants According to Number of Acute Migraine Agent Drug Classes Used | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | Number of participants categorized by the number of distinct acute migraine agent drug classes used is reported in this outcome measure. Categories included 1 drug class, 2 or more drug classes, and 3 or more drug classes. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | Total Number of Prevention Migraine Agent Drug Classes Used | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | Preventive migraine agents included: anticonvulsants, beta blocker, antidepressant, CGRP mAb, botox, and gepant \[prevention treatment including Nurtec\]. Total number of distinct preventive migraine agent drug classes used by participants is reported as mean in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | Number of Participants According to Number of Prevention Migraine Agent Drug Classes Used | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | Number of participants categorized by the number of distinct prescription preventive migraine agent drug classes used reported in this outcome measure. Categories included use of 1 drug class, 2 or more drug classes, and 3 or more drug classes. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | Number of Participants According to Current Migraine Treatments | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | Number of participants according to current migraine treatments on drug classes including: Nurtec (rimegepant) only, acute agents, triptans, NSAIDs, opioids, barbiturates, ergots, gepants \[acute; including Nurtec\], ditan, combination analgesics, and other acute treatment (aspirin lysine/metoclopramide hydrochloride monohydrate or indometacin/caffeine/prochlorperazine), prevention agents (anticonvulsants, beta-blocker, antidepressant, CGRP mAb, botox, and gepant) are reported in this outcome measure. One participant could receive more than one migraine treatment. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | Number of Participants According to Treatment Satisfaction of Migraine Drug Class | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | Number of participants according to treatment satisfaction for the migraine drug classes including: acute agents, NSAIDs, opioids, barbiturates, ergots, gepants (acute), ditans, combination analgesics, other, prevention agents, anticonvulsants, beta blockers, antidepressants, CGRPs mAb, botox, and gepant reported in this outcome measure. Treatment satisfaction for each of the migraine drug class was categorized as: extremely dissatisfied, very dissatisfied, somewhat dissatisfied, neither dissatisfied nor satisfied, somewhat satisfied, very satisfied, extremely satisfied. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | Number of Participants According to Current Migraine Treatments on OTC Class | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | Participants were categorized based on current use of OTC migraine treatments, including analgesics (acetaminophen only), analgesics (combination), NSAIDs, and other OTCs. |
| Primary | Number of Participants According to Treatment Satisfaction of Analgesics (Acetaminophen Only) | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study | Number of participants according to treatment satisfaction for analgesics (acetaminophen only) is reported in this outcome measure. Treatment satisfaction was categorized as: extremely dissatisfied, very dissatisfied, somewhat dissatisfied, neither dissatisfied nor satisfied, somewhat satisfied, very satisfied, extremely satisfied. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | Number of Participants According to Treatment Satisfaction to Rimegepant or Triptans | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study | Number of participants according to treatment satisfaction for rimegepant or triptans is reported in this outcome measure. Treatment satisfaction was categorized as: extremely dissatisfied, very dissatisfied, somewhat dissatisfied, neither dissatisfied nor satisfied, somewhat satisfied, very satisfied, extremely satisfied. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | Research and Development (RAND-36) Physical Component Score, Mental Component Score and Global Health Score - Primary Analysis | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | RAND-36=standardized survey evaluating 8 domains of functional health and well-being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Score for each of the 8 domains were scaled from 0=worst condition to 100=best condition, higher scores indicated better health status. These 8 domains were summarized as summary scores: physical component scores (derived from physical functioning, role physical, bodily pain, general health), mental component scores (derived from social functioning, role emotional mental health and vitality) and global health composite score (derived from physical and mental component scores). Each of the summary scores were standardized to a T-score with mean=50 and SD=10. Scores ranged from 0 to 100, where 0 (worst condition) to 100 (best condition), where higher scores represent better health status. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Index Score - Primary Analysis | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | EQ-5D-5L is participant completed questionnaire that consisted of two components: a five-item health state profile and visual analog scale (VAS). EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised health state/a single utility index value. E.g. if a participant responds "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses) had unique predefined utility index value assigned to it per US value sets, by EuroQol. Index scores ranged from -0.59 to 1; where 1 =best possible health state. Negative values= health states perceived as worse than dead, (death=0). Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | EQ-5D-5L Visual Analog Scale (VAS) Score - Primary Analysis | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | The EQ-5D-5L is a participant completed questionnaire that consisted of two components: a five-item health state profile and a VAS. EQ-5D VAS was used to record participant's rating for his/her current health state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | Percentage of Work Time Missed in Past 7 Days Based on Work Productivity and Activity Impairment - General Health (WPAI-GH) Questionnaire- Primary Analysis | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | The WPAI is a standardized Patient reported outcome (PRO) that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage of work time missed ranged from 0 (no impairment/high productivity) to-100% (total loss of work productivity) with higher score indicating greater impairment and less productivity. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | Percentage Impairment Experienced While at Work in Past 7 Days Based on WPAI-GH Questionnaire- Primary Analysis | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage impairment experienced ranged from 0 (no impairment/high productivity/high impairment) to 100% (total loss of work productivity) with higher score indicating greater impairment and less productivity. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | Percentage Overall Work Impairment in Past 7 Days Based on WPAI-GH Questionnaire- Primary Analysis | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage overall work impairment experienced ranged from 0 (no impairment/high productivity/high impairment) to 100% (total loss of work productivity/high impairment) with higher score indicating greater impairment and less productivity. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | Percentage Total Activity Impairment in Past 7 Days Based on WPAI-GH Questionnaire- Primary Analysis | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage of total activity impairment ranged from 0 (no impairment/high productivity) to 100% (total loss of work productivity/high impairment) with higher score indicating greater impairment and less productivity. In this outcome measure, percentage total activity impairment among total population, employed, unemployed and disabled is reported. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | Migraine Disability Assessment Scale (MIDAS) Total Score and Individual Item Scores- Primary Analysis | 3 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | MIDAS is a retrospective, self-administered, 7-item questionnaire that measured headache-related disability as lost time due to headache from paid work or school, household work, and non-work activities. Participants provided the number of missed work or school days (MIDAS Item 1); missed household chores days (MIDAS Item 2); missed social or leisure activity days (MIDAS Item 3); and days with productivity loss at work or school (MIDAS Item 4), days with productivity loss in household work (MIDAS Item 5), frequency of headaches (MIDAS Item 6) and the intensity of the headache pain (MIDAS Item 7). The score ranged from 0 (no disability) to 90 (maximum disability) for each of individual item scores. The 5 item scores (Item 1 to Item 5) were summed to compute the MIDAS total score ranging from 0 (no disability) to 450 (maximum disability). Lower scores indicate less headache-related disability. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
| Primary | Number of Participants According to MIDAS Grade- Primary Analysis | 3 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. | MIDAS is a retrospective, self-administered, 7-item questionnaire that measured headache-related disability as days with lost time or productivity due to headache from paid work or school, household work, and non-work activities. Participants were categorized according to MIDAS scores as Grade I = Little or No Disability (Score: 0-5), Grade II= Mild Disability (Score: 6-10), Grade III = Moderate Disability (Score: 11-20), Grade IV =severe disability (Score: \>=21). Analysis was performed using IPTW method to adjust for confounding by the covariates. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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