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DFN-02

Phase 3

Acute Migraine | Small molecule | Neurology |Dr. Reddy's Laboratories Ltd|Last Updated: Mar 9, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment167
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02279082DFN-02 Open Label Safety Study in Patients With Acute MigrainePHASE3 COMPLETED 167Sep 1, 2014Mar 1, 2016Mar 9, 201824 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment Emergent Adverse Events
6 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DFN-02EXPERIMENTALDFN-02 to be taken during migraine attack
Interventions
NameTypeDescription
DFN-02DRUGActive Experimental Drug
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: 1. Patients with a history of acute migraine (using International Classification of Headache Disorders \[ICHD\] criteria, second edition); 2. Patients who, in the opinion of the investigator, are willing and able to: * Return to the study site within 72 hours of the first us...

Countries:United States
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