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

Trial Profile

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

Recruiting
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
  • Most Recent Events

    • 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.
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