Parkinson's Disease
Conditions
Keywords
Parkinson's Disease, Fluctuating Parkinson's Disease, Carbidopa, Levodopa, Accordion
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.
Interventions
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
Sponsors
Intec Pharma Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) | base line ( week 1) to end of study ( week 53) | Change from Baseline to End of Study (Week 53) in Parts I-IV |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety (Adverse Events, Safety laboratory, Vital signs) | One Year | Adverse Events, Safety laboratory, Vital signs |
| Change in Parkinson's disease Questionnaire - 39 items (PDQ39). | Base line to end of study ( week 53) | Change from baseline to End of Study in Parkinson's disease Questionnaire - 39 items (PDQ39). |
Countries
Bulgaria, Germany, Israel, Italy, Poland, Slovakia, Spain, Ukraine, United Kingdom, United States
Outcome results
None listed