drugset / Trial / NCT02279082
DFN-02 Open Label Safety Study in Patients With Acute Migraine
NaSingle-groupOpen-labelTreatment
Summary
A multi-center, open-label, safety study of DFN-02 for the Treatment of Acute Migraines
Timeline
- Start
- 2014-09
- Primary completion
- 2015-09
- Completion
- 2016-03
Publications
- Background Munjal S, Gautam A, Offman E, Brand-Schieber E, Allenby K, Fisher DM. A Randomized Trial Comparing the Pharmacokinetics, Safety, and Tolerability of DFN-02, an Intranasal Sumatriptan Spray Containing a Permeation Enhancer, With Intranasal and Subcutaneous Sumatriptan in Healthy Adults. Headache. 2016 Oct;56(9):1455-1465. doi: 10.1111/head.12905. Epub 2016 Sep 10.
- Results Munjal S, Brand-Schieber E, Allenby K, Spierings ELH, Cady RK, Rapoport AM. A multicenter, open-label, long-term safety and tolerability study of DFN-02, an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM, for the acute treatment of episodic migraine. J Headache Pain. 2017 Dec;18(1):31. doi: 10.1186/s10194-017-0740-3. Epub 2017 Mar 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sumatriptan | Unknown | 10 mg | Intranasal |