DFN-11 Injection in Episodic Migraine With or Without Aura

Summary

Safety and Efficacy of DFN-11 in patients with episodic migraines with or without aura.

Timeline

Start

2015-09-21

Primary completion

2017-05-30

Completion

2018-02-26

Outcome

Met primary endpoint

paper This study met its primary endpoint, pain freedom at 2 h postdose, with DFN-11 significantly better than placebo, PMID 30112726 ↗

paper The proportion of subjects who were pain free at 2h postdose was significantly greater in the DFN-11 group than in the placebo group (51.0% vs 30.8%, P = 0.0023). PMID 30112726 ↗

Publications

• Landy S, Munjal S, Brand-Schieber E, Rapoport AM. Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: a multicenter, randomized, double-blind, placebo-controlled study. J Headache Pain. 2018 Aug 15;19(1):69. doi: 10.1186/s10194-018-0881-z.
• Landy S, Munjal S, Brand-Schieber E, Rapoport AM. Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: an 8-week open-label extension study. J Headache Pain. 2018 Aug 15;19(1):70. doi: 10.1186/s10194-018-0882-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sumatriptan	Unknown	3 mg	Subcutaneous

Indications