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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

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment167

FDA Designations

No designations recorded

Clinical trial landscape

DFN-02 · 1 trial · 1 indication

Phase 3 1
NCT02279082DFN-02 Open Label Safety Study in Patients With Acute MigraineAcute Migraine
COMPLETED167 Analytics
PHASE3COMPLETED
DFN-02 Open Label Safety Study in Patients With Acute Migraine
Acute MigraineUnlock trial analytics

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 to 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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Frequently asked questions about DFN-02

What is DFN-02 used for?

DFN-02 is an investigational small molecule being developed for the treatment of acute migraine. It is currently in Phase 3 clinical development, though the specific mechanism of action has not been disclosed. The drug is intended to provide relief for patients experiencing acute migraine attacks.

Who makes DFN-02?

DFN-02 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY. The company is conducting clinical trials to evaluate the safety and efficacy of DFN-02 for the treatment of acute migraine.

What phase is DFN-02 in?

DFN-02 is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial for DFN-02 has been completed, and the drug is being evaluated for its safety and tolerability in patients with acute migraine.

What clinical trials is DFN-02 in?

DFN-02 has been studied in one completed Phase 3 clinical trial with the identifier NCT02279082. This open-label safety study enrolled 167 patients with acute migraine in the United States. The trial was not randomized or double-blinded and had no control group, focusing on safety outcomes.

Is DFN-02 FDA approved?

DFN-02 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. The completed Phase 3 trial, NCT02279082, was an open-label safety study, and the drug has not yet received regulatory approval for the treatment of acute migraine.