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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment63

FDA Designations

No designations recorded

Clinical trial landscape

DFN-15 Dose A · 1 trial · 1 indication

Phase 2 1
NCT02472418Two Dose Levels of DFN-15 vs. Placebo in Patients With Migraine HeadachesMigraine
COMPLETED63 Analytics
PHASE2COMPLETED
Two Dose Levels of DFN-15 vs. Placebo in Patients With Migraine Headaches
MigraineUnlock trial analytics

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 to 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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Competitive Landscape -Migraine 30 trials

Frequently asked questions about DFN-15 Dose A

What is DFN-15 Dose A used for?

DFN-15 Dose A is an investigational small molecule being developed for the treatment of migraine. It is currently in Phase 2 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.

Who makes DFN-15 Dose A?

DFN-15 Dose A is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting clinical trials to evaluate the drug's potential in treating migraine.

What phase is DFN-15 Dose A in?

DFN-15 Dose A is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy for the treatment of migraine.

What clinical trials is DFN-15 Dose A in?

DFN-15 Dose A has been studied in one completed Phase 2 clinical trial, identified as NCT02472418. This trial, titled 'Two Dose Levels of DFN-15 vs. Placebo in Patients With Migraine Headaches,' was a randomized, double-blind, placebo-controlled study conducted in the United States with 63 participants.

Is DFN-15 Dose A the same as DFN-15?

DFN-15 Dose A is a specific dose level of the investigational drug DFN-15. The clinical trial NCT02472418 evaluated two dose levels of DFN-15 against placebo in patients with migraine, and DFN-15 Dose A refers to one of those dose levels being tested.