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

Intec Pharma

Status and phase: Unknown; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: Accordion Pill™ Carbidopa/Levodopa

Study type: Interventional

Funder types: Industry

Identifiers

NCT02615873

IN 11 004 OLE

Details and patient eligibility

About

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).

Full 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.

Enrollment: 460 estimated patients

Sex: All

Ages: 30 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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460 participants in 1 patient group

AP CD/LD

Experimental group

Description:

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

Treatment:

Drug: Accordion Pill™ Carbidopa/Levodopa