Concept Elicitation Qualitative Study: Migraine Patient Experiences with Zavegepant

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Evaluation of patient-reported outcomes
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medicinal product name, other:
  Zavegepant (Zavzpret 10mg)
• Study drug International non-proprietary name (INN) or common name:
  RIMEGEPANT
• Anatomical Therapeutic Chemical (ATC) code:
  (N02CD08) zavegepant

  zavegepant
• Medical condition to be studied:
  Migraine

Population studied

• Short description of the study population:
  Adult participants (18 years old or older) who have used zavegepant (Zavzpret) at least once in the past 3 months and who reside in the United States. ; Participants who indicates or exhibits speaking or hearing difficulties, or lacks sufficient understanding of English, which would make a telephone conversation challenging will be excluded. ; Participants will be enrolled after providing their consent to participate in the study.
• Age groups:
  • Adult and elderly population (≥18 years)
• Estimated number of subjects:
  20

Study design details

• Study design:
  This is a non-interventional, cross-sectional qualitative study involving one-on-one interviews with eligible participants.
• Main study objective:
  The study aims to assess patient´s perceptions and experiences regarding the use of zavegepant as an acute treatment treatment for migraine in the real-world setting in the United States.
• Setting:
  Participants will be identified and recruited from patient panels. ; A third-party vendor will recruit respondents from known migraine patients who have previously opted in to participating in research. ; Before providing their informed consent to participate in the study, participants will complete a screener to determine their eligibility and assess their overall experience (positive, neutral, or negative) with the medication. ; If eligible, an online conferencing/telephone interview will be conducted. ; The recruitment and data collection are expected to take place over a period of 10 weeks.
• Outcomes:
  • Overall experience using zavegepant for acute migraine treatment including perceived effectiveness, speed of effect, duration of benefit, and return to function ; • Perceived benefits and perceived risks/drawbacks of use, including, but not limited to, side effects, poor usability, and access barriers ; • Decision-making and trade-offs, including how participants balanced experienced benefits against drawbacks/risks and how they weighed potential risks associated with acute migraine treatments ; • Usability and real-world use context, such as portability/convenience, ease/difficulty continuing use, and barriers/facilitators related to healthcare system access ; • Overall satisfaction with zavegepant on a 1–10 scale, where 10 indicates highest satisfaction ; • Attribute importance rankings using a point-allocation task in which participants assigned points across predefined attributes, with the total summing to 100: freedom from pain; speed of pain relief; return to normal function; duration of effectiveness; nasal spray as mode of administration; nasal discomfort from using spray; and taste of the medicine ; • Taste disturbance characterization and impact, when applicable: description of taste; duration; severity rating (1=not at all severe to 10=extremely severe); perceived impact on quality of life (1=no impact to 10=extreme impact); strategies used to mitigate taste; and whether taste affected willingness to use or decisions to ; delay/avoid zavegepant ; ; Other outcomes relevant to context and interpretation included patient-reported impacts of zavegepant on daily life, physical functioning, and emotional well-being as described during open-ended questioning.
• Data analysis plan:
  Qualitative thematic analysis requires judgment in code development, coding, and theme synthesis. To support rigor and reduce interpretive bias, transcripts were coded using a structured codebook developed iteratively and reviewed by multiple researchers.15 The protocol specified that an initial coding system would be developed using early transcripts, reviewed by a second outcomes researcher, and refined through collaborative discussion; the research team also incorporated reflexivity and triangulation. This collaborative review of coded data at multiple time points assessed concept or code saturation to confirm that key themes had been sufficiently captured.16 While descriptive counts of coded concepts may be used to contextualize findings, these should not be interpreted as precise prevalence estimates.
• Summary results:
  Participants had a median age of 43 years (range 23–63); most were female (87%), White/Caucasian (93.3%), and not Hispanic or Latino/a (93.3%). Most first learned about zavegepant from a healthcare provider (86.7%). Common reasons for initiation were inadequate efficacy of prior acute treatments (73.3%) and physician recommendation (46.7%). Participants reported a mean of three prescription acute migraine medications ; available and used zavegepant for a mean of 58% of migraine attacks. Overall satisfaction was generally high, with a mean rating of 7.3 on a 1–10 scale and 80% rating satisfaction between 7 and 10. Valued attributes included rapid action and convenience/portability (53.3% each) and perceived effectiveness (46.7%). In the point-allocation exercise, freedom from pain and speed of effect were the most important attributes. Dysgeusia/bad taste was the most frequently disliked aspect (66.7%). Among participants reporting dysgeusia, taste was described as bitter, metallic, and lingering; the average rating for taste was 6.8 on a 1; 10 scale (1=not at all severe to 10=extremely severe taste disturbance), with reported duration ranging from 30 minutes to 5 hours. Some participants reported avoiding or hesitating to use zavegepant because of taste, although many described accepting this drawback when perceived benefits were meaningful.