Summary

for people ages 30-100 (full criteria)
at Reseda, California and other locations
study started
estimated completion

Description

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).

Official Title

An Open-Label,Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects Who Completed Study IN 11 004

Details

This will be a multi-center, global, open-label study in adult suffering from fluctuating Parkinson's disease subjects who have successfully completed the core study IN 11 004.

After signing informed consent and meeting inclusion/exclusion criteria, eligible subjects will be enrolled into a 12-month open-label extension and receive the AP-CD/LD as needed.

Efficacy and safety will be assessed throughout the study period.

Keywords

Parkinson's Disease Fluctuating Parkinson's Disease Carbidopa Levodopa Accordion Parkinson Disease Carbidopa, levodopa drug combination Accordion Pill™ Carbidopa/Levodopa

Eligibility

You can join if…

Open to people ages 30-100

  1. Subjects who successfully completed the core study IN 11 004 and, in the opinion of the Investigator, would benefit from long-term treatment with AP-CD/LD
  2. Continue to carry the diagnosis of Parkinson's disease consistent with UK brain bank criteria
  3. Has a good response to Levodopa in the opinion of the investigator
  4. Subjects able and willing to give written (signed and dated) informed consent to participate in the study

You CAN'T join if...

  1. Participation in another clinical trial other than IN 11 004 and receipt of an investigational medication other than that administered in the context of IN 11 004 within 28 days prior to the planned start of treatment
  2. Previous or planned neurosurgical or Duodopa treatment for Parkinson's Disease (e.g., procedures including ablation or deep brain stimulation)
  3. Non-selective monoamine oxidase (MAO) inhibitors within 28 days prior to Baseline Visit or planned administration during study participation
  4. If, in the opinion of the Investigator, subject should not participate in the study
  5. Women who are pregnant or nursing. Women of childbearing potential who are not willing to use a medically acceptable method of contraception.

Locations

  • SC3 Research not yet accepting patients
    Reseda California 91335 United States
  • SC3 Research not yet accepting patients
    Pasadena California 91105 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Intec Pharma Ltd.
Links
Sign up for this study
ID
NCT02615873
Phase
Phase 3
Study Type
Interventional
Last Updated