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ClinicalTrials.gov ID

NCT02615873

Lead Sponsor

Intec Pharma Ltd.INDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 3

Enrollment

460Estimated

Last Update Posted

Aug 14, 2018Actual

Start Date

Jul 2016

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

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

Brief 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).

Detailed Description

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.

• Parkinson's Disease

• Accordion Pill™ Carbidopa/Levodopa

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Intec Pharma Ltd.INDUSTRY

972-3-6973061