A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 29 Aug 2017
At a glance
- Drugs Levodopa (Primary)
- Indications Parkinson's disease
- Focus Adverse reactions; Registrational
- Acronyms OFF Phenomena
- Sponsors Acorda Therapeutics; Civitas Therapeutics
- 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.
- 29 Aug 2017 According to an Acorda Therapeutics media release, the company has received a Refusal to File (RTF) letter from the U.S. FDA regarding its NDA for INBRIJA. In the preliminary review, FDA determined that NDA was not sufficiently complete to permit a substantive review. Reasons for the RTF are the date when the manufacturing site would be ready for inspection and a question regarding the submission of the drug master production record. FDA also requested additional information at resubmission.
- 30 Jun 2017 Status changed from recruiting to active, no longer recruiting.