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Eletriptan HBr

Phase 3

Migraine Without Aura | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Jan 27, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment971
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01859481Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose StudyPHASE3 COMPLETED 971 — — Mar 1, 2000Mar 1, 2002Jan 27, 2021148 Belgium, Czechia +12
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Study Endpoints
Primary Endpoints
Consistency of headache response (3 responses out of 3 active treated attacks) . Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose.
24 weeks
Secondary Endpoints
Consistency of headache response (2 responses out of 3 active treated attacks). Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose.
24 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
Eletriptan HBr 40 mgEXPERIMENTAL -
Eletriptan HBr 80 mgEXPERIMENTAL -
Interventions
NameTypeDescription
PlaceboDRUGAll subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
Eletriptan HBr 40 mgDRUGAll subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
Eletriptan HBr 80 mgDRUGAll subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites148

Inclusion Criteria: * Male and Female subjects in good general health, aged 18 to 65 years. * Subjects should meet IHS diagnostic criteria for migraine with or without aura. * Based on past history, subjects should expect to suffer at least one acute attack of migraine with or without aura, each 6 ...

Countries:BelgiumCzechiaDenmarkFranceGermanyGreeceHungaryItalyNetherlandsNorwayPortugalSpainSwedenTurkey (Türkiye)
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