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A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients

NCT02605434 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2019-08-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Accordion Pill™ Carbidopa/Levodopa

AP-CD/LD capsule containing 50 mg carbidopa with 400 mg or 500 mg levodopa administered orally twice or 3 times a day

DRUG

Sinemet®

Sinemet® tables containing carbidopa and levodopa 25/100 mg will be administered orally at least 4 times a day according to patients need

DRUG

Placebo -AP-CD/LD

Placebo for AP-CD/LD capsule

DRUG

Placebo- Sinemet

Placebo for Sinemet tables

Sponsors & Collaborators

  • Intec Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Peter A LeWitt, MD · Henry Ford Hospital - West Bloomfield

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-07-31
Completion
2019-12-31

Countries

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

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02605434 on ClinicalTrials.gov