Welcome to the CTH-302 study

Have you been diagnosed with Parkinson’s Disease and continue to experience “OFF” episodes while taking a stable dose of your prescribed medication?

You may be able to take part in a clinical research study investigating a way to administer a medication to patients that could be used to treat “OFF” states.

Find out if you could be eligible here

Overview

Parkinson’s Disease (PD) is the second most common neurodegenerative disease, characterised by symptoms including tremors, impaired posture, changes in speech (or handwriting), slowed movement and muscle stiffness.

Early on, these symptoms are often well managed by prescribed treatments. However, as the disease progresses other symptoms can develop such as involuntary and uncontrolled movement or motor fluctuations – rapid changes in the level of control you have over your movements. These symptoms can become harder to control and predict over time and are referred to as an “OFF” state.

The CTH-302 study will evaluate the efficacy and safety of administering apomorphine as a film placed under the tongue compared with subcutaneous (under the skin) apomorphine injections in patients with PD complicated by motor fluctuations. This medicine is investigational and has not been approved by the NHS or European Health Authorities.

How do I take part?

Could I be eligible?

In order to take part in the CTH-302 study, you must attend a screening visit to determine if you meet certain requirements. Some of the basic criteria require that you must:

  • Be at least 18 years old
  • Have a diagnosis of PD
  • Be on a stable dose of Levodopa
  • Be suffering from daily “OFF” episodes lasting at least 2 hours per day
  • Not be pregnant, trying to conceive or nursing an infant
  • Never have suffered a stroke
  • Not suffer from type 1 diabetes

Other requirements will be reviewed with the study centre staff if you meet the basic requirements above.

If you do meet these requirements and are interested in speaking to a study centre, find your local study centre here.

find your local study centre here

What does the CTH-302 study involve?

The CTH-302 study runs for a duration of approximately 4 months from the day of your first screening visit. During the study you will continue to take your regular medication, however, there may be times that you are asked to withhold your medication until arrival at the study centre.

The CTH-302 study will compare taking the medicine apomorphine in two different ways:

  • A thin film that is placed under the tongue - APL-130277 (the investigational study form of the medication)
  • By subcutaneous injection - an approved method for taking apomorphine, commonly prescribed for the treatment of advanced PD

Your participation in the CTH-302 study is voluntary and you may choose to leave the study at any time.

What can I expect if I participate in the CTH-302 study?

The screening visits will involve initial assessments from study doctors to confirm that you are well enough to participate in the study, and that you meet all of the requirements. As part of these visits, the study centre staff will explain all procedures and answer any questions you may have. After the screening visits, each participant will be randomly assigned to 1 of 2 groups to determine the order in which APL-130277 and subcutaneous apomorphine will be taken. You will not be able to choose which group you are assigned to.

During the first phase of the study you will be randomly assigned to take either APL-130277 or subcutaneous apomorphine. You will take increasing doses and the study centre staff will monitor your response until the most effective dose is reached. You will then cross over to the other treatment, either APL-130277 or subcutaneous apomorphine. You will again take increasing doses and the study centre staff will monitor your response until the most effective dose is reached.

During the second phase of the study you will be randomly assigned to four weeks of either APL-130277 or subcutaneous apomorphine at the dose selected in the first phase. You will then be assigned to the other treatment for an additional four weeks of treatment.

Whilst participating in the study you will be required to attend a study visit at least once every 2 weeks, with telephone appointments in between. Study visits will involve both physical assessments and questionnaires, and you will be able to ask the study centre staff any questions you may have. You will also be required to complete a simple daily home dosing diary which the study centre staff will explain to you.

Your participation in the CTH-302 study is voluntary and you may withdraw from the study at any time.

If you would like to find out more, please contact your local study centre.

This study has been ethically approved by the Dulwich Ethics Committee.

local study centre

What if I am unable to attend a visit?

If for any reason you are unable to attend one of your scheduled study visits, you will need to get in contact with your study centre staff to rearrange as soon as possible.

How much does it cost to participate in the CTH-302 study?

All study visits, tests and medications will be provided at no cost to you. Reimbursement for study-related travel may also be provided