An Extension Study of Experimental AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed Study IN 11 004
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Age: 30 to 100 years old
Gender:
Any
Healthy Volunteers: No
Keywords: PARKINSON'S DISEASE, extension study
Type: Drug study, Phase 3
Target:
6 Participants
Investigator:
Description
Parkinson's disease (or PD) is a disease that slowly damages the motor system. The motor system is the part of the central nervous system that is involved with movement. When a person gets Parkinson's disease, the cells that make dopamine in a part of the brain die. Dopamine cells send information to other cells which makes us do the actions we do.

This study will test the long-term safety, tolerability and effectiveness of the experimental Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD). It will be used in patients with fluctuating Parkinson’s disease (PD) who completed the main study (IN 11 004). We will study how AP-CD/LD affects the symptoms of Parkinson’s disease long-term. We will evaluate participant responses on questionnaires, rating scales and examinations. Patients will also have the opportunity for extended treatment with AP-CD/LD. This will occur after they have successfully completed the main study IN 11 004.

The name of the experimental drug that will take in this study is Accordion Pill™ Carbidopa/Levodopa. This is an oral drug (capsule) for the treatment of PD symptoms (motor and non-motor fluctuations). The Accordion Pill™ Carbidopa/Levodopa contains two drugs: levodopa combined with carbidopa. The Accordion Pill™ Carbidopa/Levodopa was developed by Intec Pharma Ltd. to extend the duration of the Levodopa activity and its effectiveness by keeping the drug in the stomach for a longer time. In this form, this product is known as the “experimental drug”. Experimental means that the drug has not yet been approved by the Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

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.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
The sponsor will reimburse you for costs associated with travel (mileage, tolls, parking fees, etc.) to and from the study site at up to $275/visit. Mileage will be determined by Google Maps. Alternatively, car service arrangements may be made on your behalf, and paid by the sponsor. These are to take you to and from study appointments if you live within 3 hours of the study site. The sponsor will also reimburse you for the cost of meals and accommodations (hotel) at up to $120 per visit. You must provide documentation such as receipts for tolls, parking, taxi, bus fare, etc. You may be reimbursed up to $75 for the cost of rescue medication if you need it during the study.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for up to 54 weeks (about 1 year).
Recruitment period
From Jan. 6, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Parkinson's Disease