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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Accordion Pill™ Carbidopa/Levodopa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Continue to carry the diagnosis of Parkinson's disease consistent with UK brain bank criteria Has a good response to Levodopa in the opinion of the investigator Subjects able and willing to give written (signed and dated) informed consent to participate in the study Exclusion Criteria: 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 Previous or planned neurosurgical or Duodopa treatment for Parkinson's Disease (e.g., procedures including ablation or deep brain stimulation) Non-selective monoamine oxidase (MAO) inhibitors within 28 days prior to Baseline Visit or planned administration during study participation If, in the opinion of the Investigator, subject should not participate in the study Women who are pregnant or nursing. Women of childbearing potential who are not willing to use a medically acceptable method of contraception.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AP CD/LD<br>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 | Drug: Accordion Pill™ Carbidopa/Levodopa<br>* 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<br>* Other names: AP CD/LD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale (UPDRS) | Change from Baseline to End of Study (Week 53) in Parts I-IV | base line ( week 1) to end of study ( week 53) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Adverse Events, Safety laboratory, Vital signs) | Adverse Events, Safety laboratory, Vital signs | One Year | 
| Change in Parkinson's disease Questionnaire - 39 items (PDQ39). | Change from baseline to End of Study in Parkinson's disease Questionnaire - 39 items (PDQ39). | Base line to end of study ( week 53) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Fluctuating Parkinson's Disease, Carbidopa, Levodopa, Accordion