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: 07 Dec 2017
At a glance
- Drugs Levodopa (Primary)
- Indications Parkinson's disease
- Focus Adverse reactions; Registrational
- Sponsors Acorda Therapeutics; Civitas Therapeutics
- 07 Dec 2017 According to an Acorda Therapeutics media release, the company announced the resubmission of its New Drug Application (NDA) for INBRIJA to the U.S. Food and Drug Administration (FDA).
- 31 Oct 2017 According to an Acorda Therapeutics media release, company is planning to resubmit the INBRIJA NDA in the fourth quarter of 2017.
- 29 Aug 2017 According to an Acorda Therapeutics media release, the company is planning a Type A meeting with the FDA to respond to the issues and to seek clarification of what additional information will be required for NDA resubmission.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History