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DFN-11

Phase 3

Episodic Migraine | Small molecule | Neurology |Dr. Reddy's Laboratories Ltd|Last Updated: Jul 26, 2018

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 Enrollment268
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02569853DFN-11 Injection in Episodic Migraine With or Without AuraPHASE3 COMPLETED 268 — — Sep 21, 2015Feb 26, 2018Jul 26, 201816 United States
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Study Endpoints
Primary Endpoints
The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 2 Hours After Dosing as Reported by the Subject in the eDiary
2 hours
Secondary Endpoints
The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 1 Hour After Dosing as Reported by the Subject in the eDiary
1 hour
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DFN-11EXPERIMENTALDFN-11 active injection upon occurrence of migraine
PlaceboPLACEBO_COMPARATORPlacebo injection upon occurrence of migraine
Interventions
NameTypeDescription
DFN-11DRUG -
PlaceboOTHER -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: 1. If female, a subject must have a negative serum pregnancy test at screening, does not plan to become pregnant during the study, and is not lactating 2. If female, a subject also must have a negative urine pregnancy test at all subsequent study visits after the Screening Visit...

Countries:United States
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