A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Tolerability, and Safety Study of DFN-15 in Episodic Migraine With or Without Aura

Episodic migraine is a diagnosis applied to patients with migraine who experience 1-14 headache days per month. The study drug in this trial, DFN-15 (celecoxib oral solution), is an NSAID. Migraine treatment with NSAIDs can produce analgesia similar to that from opioid treatment, while sparing patients from opioid-associated side effects (i.e. sedation, nausea, and/or vomiting). The objective of this trial is to demonstrate the tolerability, safety, and efficacy of DFN-15 for the acute relief of migraine. This study will assess the proportion of patients who are free from pain and/or their most bothersome migraine symptom after treatment with the study drug.

Primary Sponsor:
Dr. Reddy’s Laboratories

Prinicipal Investigator:
John Rothrock, MD/Neurology

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