EXPLORE
THE IMPACT
OF MIGRAINE

OBJECTIVE: To investigate the safety and efficacy of VYEPTI for migraine prevention in patients with documented previous preventive treatment failures arising from inadequate efficacy, tolerability reasons, or contraindications.

KEY INCLUSION CRITERIA: Adults aged 18–75 years with an onset of migraine at age 50 years or younger were eligible for participation if they had episodic or chronic migraine (as per the 3rd edition of the International Classification of Headache Disorders [ICHD-3]) for ≥12 months before screening, and documented evidence of two-to-four previous preventive treatment failures within the past 10 years. Chronic migraine criteria were migraine occurring on at least 8 days and headache occurring on more than 14 days during the screening period, and episodic migraine criteria were migraine occurring on at least 4 days and headache occurring on up to 14 days during the screening period.

PRIMARY ENDPOINT: The change from baseline in the number of monthly migraine days following the first infusion (weeks 1–12).

SECONDARY ENDPOINTS: The proportions of patients with at least 50% reduction from baseline in monthly migraine days (i.e., ≥50% migraine responder rate) in weeks 1–12, ≥75% reduction from baseline in monthly migraine days (i.e., ≥75% migraine responder rate) in weeks 1–12, and change from baseline in the number of monthly migraine days following the second infusion (weeks 13–24).

OBJECTIVE: To evaluate the efficacy and safety of VYEPTI in the preventive treatment of episodic migraine. 

KEY INCLUSION CRITERIA: Adults 18–75 years of age (inclusive) with a diagnosis of migraine per ICHD criteria before the age of 50 years with a history of migraine for ≥12 months with ≤14 headache days per month, including ≥4 migraine days, in the 3 months prior to screening. 

PRIMARY ENDPOINT: The change from baseline in mean monthly migraine days (weeks 1–12).

SECONDARY ENDPOINTS: The key secondary efficacy endpoints were ≥75% migraine responder rate over weeks 1–4, ≥75% migraine responder rate over weeks 1–12, ≥ 50% migraine responder rate over weeks 1–12, and percentage of patients with a migraine on the day after dosing. Other secondary endpoints using the eDiary included change in acute migraine medication days (weeks 1–12), 100% migraine responder rates, and headache endpoints.

OBJECTIVE: Post hoc analysis of the PROMISE-1 and PROMISE-2 trials to determine the onset of preventive efficacy with VYEPTI in patients with migraine.

KEY INCLUSION CRITERIA: Adults 18–75 (inclusive) with episodic migraine per ICHD criteria (PROMISE-1)¹² and adults 18–65 years of age (inclusive) with a diagnosis of chronic migraine (PROMISE-2).⁸

Post hoc analysis methods: The presence or absence of a migraine on specific days was selected as the measurement tool (reductions in monthly migraine frequency are not directly useful in determining onset of efficacy).

The timing of treatment onset was determined by finding the first day from which a treatment effect was nominally significant and sustained without interruption through to the end of the first dosing interval (week 12).

OBJECTIVE: This post hoc analysis of the PROMISE-2 study in patients medically diagnosed with chronic migraine and MOH evaluated reductions in the use of acute headache medication (AHM) and sustained changes in the diagnostic status of chronic migraine and MOH following VYEPTI treatment (100 mg or 300 mg) in the PROMISE-2 study.

KEY INCLUSION CRITERIA: The diagnosis of MOH was conducted as a prespecified measure of the primary efficacy endpoint in PROMISE-2.

POST HOC ANALYSIS METHODS: Analyses in the MOH subgroup included the change in monthly AHM days, in total and by class (triptan, ergotamine, simple analgesics, combination analgesics [combination of drugs of different classes acting as analgesics or adjuvants], and opioids); the percentage of patients using AHM at or above MOH diagnostic thresholds, as well as the number of study months (4-week intervals) patients used AHM below MOH diagnostic thresholds; the percentage of patients experiencing a monthly

OBJECTIVE: To investigate the safety and efficacy of VYEPTI for migraine prevention in patients with documented previous preventive treatment failures arising from inadequate efficacy, tolerability reasons, or contraindications.

KEY INCLUSION CRITERIA: Adults aged 18–75 years with an onset of migraine at age 50 years or younger were eligible for participation if they had episodic or chronic migraine (as per the 3rd edition of the International Classification of Headache Disorders [ICHD-3]) for ≥12 months before screening, and documented evidence of two-to-four previous preventive treatment failures within the past 10 years. Chronic migraine criteria were migraine occurring on at least 8 days and headache occurring on more than 14 days during the screening period, and episodic migraine criteria were migraine occurring on at least 4 days and headache occurring on up to 14 days during the screening period.

PRIMARY ENDPOINT: The change from baseline in the number of monthly migraine days following the first infusion (weeks 1–12).

SECONDARY ENDPOINTS: The proportions of patients with at least 50% reduction from baseline in monthly migraine days (i.e., ≥50% migraine responder rate) in weeks 1–12, ≥75% reduction from baseline in monthly migraine days (i.e., ≥75% migraine responder rate) in weeks 1–12, and change from baseline in the number of monthly migraine days following the second infusion (weeks 13–24).