Efficacy, Tolerability, and Safety Study of DFN-15

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

Met primary endpoint

registry analysis (superiority test); Placebo LOCF vs DFN-15 LOCF; p <0.001; Odds Ratio (OR) 2.00 (95% CI 1.36 to 2.94); Fisher Exact NCT03006276 ↗

registry analysis (superiority test); Placebo LOCF vs DFN-15 LOCF; p = 0.007; Odds Ratio (OR) 1.68 (95% CI 1.17 to 2.43); Fisher Exact NCT03006276 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DFN-15	Unknown	—	—

Indications