A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations
Phase of Trial: Phase III
Latest Information Update: 11 Nov 2017
At a glance
- Drugs Levodopa/carbidopa (Primary)
- Indications Parkinson's disease
- Focus Registrational; Therapeutic Use
- Acronyms iNDiGO
- Sponsors NeuroDerm
- 06 Jun 2017 According to a NeuroDerm media release, the company has received a Scientific Advice Letter from the Scientific Advice Working Party of the European Medicines Agency (EMA). The letter accepts the main design elements suggested by NeuroDerm for the amended version of this trial, including study population and primary and secondary endpoints, as well as the suggested statistical analysis approach.
- 11 May 2017 According to a NeuroDerm media release, trial completion expected in parallel with BeyoND study.
- 01 Mar 2017 According to NeuroDerm media release, this trial will be restarted and amended to support a broad label claim in the EU for ND0612. The trial will be expanded from 150 to 240 patients by adding a third treatment arm of ND0612H to the current ND0612L and control arms. Furthermore, new endpoints that reflect the recent trial 006 results, including a responder analysis, will be incorporated into this trial.