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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intec Pharma Ltd.
• Collaborator: PRA Health Sciences
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa

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.