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DFN-11

Phase 3

Episodic Migraine | Small molecule | Neurology |Dr. Reddy's Laboratories Ltd|Last Updated: Feb 26, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment268

FDA Designations

No designations recorded

Clinical trial landscape

DFN-11 · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT02569853DFN-11 Injection in Episodic Migraine With or Without AuraEpisodic Migraine
COMPLETED268 Analytics
PHASE3COMPLETED
DFN-11 Injection in Episodic Migraine With or Without Aura
Episodic Migraine
NCT02569853268
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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
The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment
60 minutes post-treatment

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
Sumatriptan 3 mg then 6 mgEXPERIMENTALDFN-11 (sumatriptan, 3 mg) and placebo first then two DFN-11 injections
Sumatriptan 6 mg then 3 mgEXPERIMENTALTwo DFN-11 (sumatriptan, 3 mg) injections first then DFN-11 injection and placebo

Interventions

NameTypeDescription
DFN-11DRUG -
PlaceboOTHER -
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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about DFN-11

What is DFN-11 used for?

DFN-11 is an investigational small molecule being developed for the acute treatment of episodic migraine and rapidly escalating migraine. It is administered by injection and is currently in clinical development, having completed Phase 3 and Phase 2 trials in the United States.

Who makes DFN-11?

DFN-11 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company has conducted clinical trials for DFN-11 in the United States for the treatment of migraine.

What phase is DFN-11 in?

DFN-11 has completed Phase 3 clinical development for episodic migraine. It is not FDA approved and remains an investigational drug. A Phase 2 trial for rapidly escalating migraine has also been completed, but the drug is not yet approved for any indication.

What clinical trials has DFN-11 been in?

DFN-11 has been studied in two completed clinical trials. NCT02569853 was a Phase 3, randomized, double-blind, placebo-controlled trial in 268 patients with episodic migraine. NCT02571049 was a Phase 2 pilot study in 24 patients with rapidly escalating migraine, testing two different strengths of the injection.

Is DFN-11 the same as other migraine drugs?

DFN-11 is a distinct investigational drug developed by Dr. Reddy's Laboratories. It is not known to be the same as any other marketed migraine medication. Its mechanism of action has not been disclosed in available information, and it is being studied specifically for acute migraine treatment.