US-based cross-sectional survey in patients taking lasmiditan: Functional REstoration with rEyvow (FREE)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LASMIDITAN
• Medical condition to be studied:
  Migraine

Population studied

• Short description of the study population:
  Adult patients in US who have redeemed a REYVOW savings card and have taken lasmiditan at least once in the past month for treatment of a migraine attack prior to completing the survey.; Inclusion Criteria; The study will include all participants who meet the following criteria:; 1. Age ≥18 at time of study; 2. Enrolled in US REYVOW patient support program; 3. Redeemed a REYVOW Savings Card; 4. Provide informed consent to participate in the study; 5. Have taken lasmiditan in the past month prior to completing the survey; Exclusion Criteria; Participants will be excluded from the study:; 1. Cannot read or understand English; 2. Cannot use a computer or smart device with internet access
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Migrane patients
• Estimated number of subjects:
  250

Study design details

• Main study objective:
  The objective of the study is to assess patients’ ability to return to their usual daily activities after treating a migraine attack with lasmiditan.
• Outcomes:
  Ability to perform and the time taken to return to usual daily activities engaged in when the migraine attack started, and Ability to return to planned activities for that day and level of impairment of those activities, Activity that was most impacted by their migraine attack prior to taking lasmiditan, the activity that the patient was most concerned about prior to taking lasmiditan, and the level of impairment of usual activities during an untreated or unsuccessfully treated attack prior to when lasmiditan was initiated
• Data analysis plan:
  All study measures will be reported descriptively using means, standard deviations, medians, and 95% confidence intervals for continuous outcome variables and frequencies and percentages for categorical outcome variables. Differences between subgroups will be evaluated: analyses will be conducted to examine whether the select study outcome measures differ by each of the subgroups, using chi-square tests for categorical variables and one-way analysis-of-variance tests (ANOVAs) for continuous variables. P-values will be provided for the omnibus test (one-way ANOVA) and pair-wise testing between the groups. It should be noted that all comparisons are conditional on whether each subgroup results in adequate sample size.

Documents

Study results

REYVOW FREE Report_ENCePP version. 14 JUN 2021_APPROVED

Study publications

Schwedt TJ, Lombard LA, Doty E, Vincent M, Mills KM, Ayer DW, et al. Functional…