Efficacy, Tolerability, and Safety of DFN-15

Phase 3 Completed 631 enrolled BioDelivery Sciences International Dr. Reddy's Laboratories Limited · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being conducted at multiple centers in the United States

Timeline

Start: 2016-12
Primary completion: 2017-11
Completion: 2019-05

Outcome

Mixed primary results

registry NUMBER DFN-15 Placebo (LOCF): 25.8 (20.7 to 31.5) percentage of subjects NUMBER DFN-15 Active (LOCF): 32.9 (27.4 to 38.7) percentage of subjects NCT03009019 ↗

registry analysis (superiority test); DFN-15 Placebo (LOCF) vs DFN-15 Active (LOCF); p = 0.075; Odds Ratio (OR) 1.40 (95% CI 0.97 to 2.03); Fisher Exact NCT03009019 ↗

registry NUMBER DFN-15 Placebo (LOCF): 45.0 (38.5 to 51.7) percentage of subjects NUMBER DFN-15 Active (LOCF): 58.9 (52.4 to 65.2) percentage of subjects NCT03009019 ↗

registry analysis (superiority test); DFN-15 Placebo (LOCF) vs DFN-15 Active (LOCF); p = 0.003; Odds Ratio (OR) 1.75 (95% CI 1.22 to 2.52); Regression, Logistic NCT03009019 ↗

Publications

Lipton RB, Munjal S, Tepper SJ, Iaconangelo C, Serrano D. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Tolerability, and Safety of Celecoxib Oral Solution (ELYXYB) in Acute Treatment of Episodic Migraine with or without Aura. J Pain Res. 2021 Aug 19;14:2529-2542. doi: 10.2147/JPR.S322292. eCollection 2021.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celecoxib	Other / unclassified	120 mg	Oral