Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Multicenter Study, With an Extension Period of Dose-blinded Active Treatment, to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions
Phase of Trial: Phase III
Latest Information Update: 14 Mar 2018
At a glance
- Drugs Botulinum-Toxin-A (Primary)
- Indications Neurological disorders; Sialorrhoea
- Focus Registrational; Therapeutic Use
- Acronyms SIAXI
- Sponsors Merz Pharma
- 14 Mar 2018 Results presented in a Merz North America media release.
- 14 Mar 2018 According to a Merz North America media release, the results of this study were presented at last years American Academy of Physical Medicine and Rehabilitation (AAPM&R) and American Congress of Rehabilitation Medicine (ACRM) annual meetings.
- 14 Mar 2018 According to a Merz North America media release, the FDA has set a Prescription Drug User Fee Act (PDUFA) action date in Q4 2018, and if approved, has the potential to make Xeomin the first neurotoxin with this indication in the U.S.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History