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Zolmitriptan

Phase 3

Migraine | Small molecule | Neurology |AstraZeneca PLC|Last Updated: Apr 6, 2009

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment2,114
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00617747Efficacy and Tolerability of Zolmitriptan Nasal SprayPHASE3 COMPLETED 2,114Sep 1, 2002Jun 1, 2003Apr 6, 2009 -
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Study Endpoints
Primary Endpoints
Improvement in migraine headache pain from severe or moderate to mild or none
15 minutes after the initial dose of trial treatment
Secondary Endpoints
Headache response rate
30 minutes and 1, 2 and 4 hours after dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ZolmitriptanDRUG5mg Nasal Spray
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subject has an established diagnosis of migraine headache, with or without aura * Subject has a medical history indicating the presence of migraine attacks for at least 1 year before the start of the trial or a minimum of 2 and maximum of 6 migraine attacks per month on averag...

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