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 (Accordance)

NCT02605434 Phase 3 UNKNOWN

The purpose of this study is to determine whether the gastric retentive Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate release Carbidopa/Levodopa in reducing motor fluctuations such as "off time" in advanced Parkinson's Disease patients.

Details

Lead sponsor	Intec Pharma Ltd.
Phase	Phase 3
Status	UNKNOWN
Enrolment	420
Start date	2016-03
Completion	2019-12

Conditions

• Parkinson's Disease

Interventions

• Accordion Pill™ Carbidopa/Levodopa
• Sinemet®
• Placebo -AP-CD/LD
• Placebo- Sinemet

Primary outcomes

• Change from Baseline through study completion, an average of 27 weeks, in the percentage of daily "Off time" during waking hours — Baseline through study completion, an average of 27 weeks
  Change from Baseline through study completion, an average of 27 weeks, in the percentage of daily "Off time" during waking hours based on Hauser Home Diary assessments; Total number of "Off " hours normalized to a 16- hour waking day will also be calculated but only a single p-value applicable to both the percentage and hours will be reported.

Countries

United States, Bulgaria, Germany, Israel, Italy, Poland, Slovakia, Spain, Ukraine, United Kingdom