A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)
Phase of Trial: Phase III
Latest Information Update: 29 Jun 2017
At a glance
- Drugs Levodopa (Primary)
- Indications Parkinson's disease
- Focus Registrational; Therapeutic Use
- Acronyms OFF Phenomena; SPAN-PD
- Sponsors Acorda Therapeutics
- 29 Jun 2017 According to an Acorda Therapeutics media release, based on the data from SPAN-PD and two long-term safety studies the company has submitted a New Drug Application (NDA) as a 505(b)(2) application to the U.S. FDA for INBRIJATM (CVT-301, levodopa inhalation powder). The Company anticipates the FDA will inform about submission and full review by the end of September 2017.
- 05 Jun 2017 Results from this trial were presented at the 2017 International Congress of Parkinson's Disease and Movement Disorders (MDS) acccording to an Acorda Therapeutics media release.
- 05 Jun 2017 Results published in an Acorda Therapeutics media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History