Phase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's Patients
Phase of Trial: Phase III
Latest Information Update: 10 Dec 2017
At a glance
- Drugs Levodopa/carbidopa (Primary) ; Levodopa/carbidopa
- Indications Parkinson's disease
- Focus Registrational; Therapeutic Use
- Acronyms Accordance
- Sponsors Intec Pharma
- 15 Nov 2017 Planned number of patients changed from 328 to 420. The Company is expanding planned enrollment to 420 patients to account for a higher than expected attrition rate during the titration period that precedes patient randomization. The enrollment is now expected to complete in the third quarter of 2018.
- 09 Aug 2017 According to an Intec Pharma media release, the company expects to complete enrollment during the fourth quarter of 2017 or the first quarter of 2018.
- 07 Aug 2017 Planned primary completion date changed from 1 Dec 2017 to 1 Jun 2018.