Trial Profile
Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease
Status:
Completed
Phase of Trial:
Phase I/II
Latest Information Update: 16 Jan 2020
Price :
$35
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At a glance
- Drugs Ebselen (Primary)
- Indications Meniere's disease
- Focus Adverse reactions
- Sponsors Sound Pharmaceuticals
- 18 Sep 2019 According to a Sound Pharmaceuticals media release, on the basis of this and othe study (289266), the FDA's Division of Neurology Products has granted Fast Track Designation to SPI-1005 in the treatment of Meniere's Disease.
- 06 Mar 2019 According to a Sound Pharmaceuticals media release, data from this trial were presented at the Association for Research in Otolaryngology meeting in 2018.
- 03 Oct 2017 According to a Sound Pharmaceuticals media release, data were submitted for presentation to the Association for Research in Otolaryngology meeting.