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A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004

NCT02615873 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2018-08-14

No results posted yet for this study

Summary

The purpose of this study is to allow evaluation of long-term clinical effect and safety outcome of treatment with AP-CD/LD, as well as to allow patients to benefit from extended treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core study IN 11 004 ('core study', a phase III, multicenter, randomized, double-blind, double-dummy, active-controlled Phase 3 study to assess the safety and efficacy of AP CD/LD versus IR CD/LD in fluctuating PD patients).

Conditions

Interventions

DRUG

Accordion Pill™ Carbidopa/Levodopa

Accordion Pill™ Carbidopa/Levodopa Capsule 50/400mg , b.i.d or t.i.d or Accordion Pill™ Carbidopa/Levodopa Capsule 50/500mg , b.i.d or t.i.d

Sponsors & Collaborators

  • Intec Pharma Ltd.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-12-31
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 NCT02615873 on ClinicalTrials.gov