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DFN-15 Dose A

Phase 2

Migraine | Small molecule | Neurology |Dr. Reddy's Laboratories Ltd|Last Updated: May 22, 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 Enrollment63
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02472418Two Dose Levels of DFN-15 vs. Placebo in Patients With Migraine HeadachesPHASE2 COMPLETED 63Jun 5, 2015May 5, 2016May 22, 20186 United States
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Study Endpoints
Primary Endpoints
Pain Free, defined as a score of "0" on a numerical scale of "0" to "3"
2 hour

Percentage of subjects who are migraine headache free at 2 hours after taking study drug administration

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DFN-15 120 mg (treatment A)EXPERIMENTALDFN-15 120 mg (treatment A)
DFN-15 240 mg (treatment B)EXPERIMENTALDFN-15 240 mg (treatment B)
Placebo (treatment C)PLACEBO_COMPARATORPlacebo (treatment C)
Interventions
NameTypeDescription
DFN-15 Dose A (treatment A)DRUGDFN-15 Dose A administered
DFN-15 Dose B (treatment B)DRUGDFN-15 Dose B administered
Placebo (treatment C)OTHERPlacebo administered
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Patients with a history of episodic migraine (as defined by International Classification of Headache Disorders \[ICHD\]-228) who experience an average of 2 to 6 migraine attacks a month for the past 12 months with no more than 14 headache days per month, and with at least 48 ...

Countries:United States
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