A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control
Phase of Trial: Phase III
Latest Information Update: 29 Jun 2017
At a glance
- Drugs Levodopa (Primary)
- Indications Parkinson's disease
- Focus Adverse reactions; Registrational
- Sponsors Acorda Therapeutics; Civitas 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 Interim results published in an Acorda Therapeutics media release.
- 05 Jun 2017 Interim 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History