A study in patients with Parkinson’s disease to evaluate a novel delayed-release, dual-pulse carbidopa and levodopa tablet, CP-012
Many people with Parkinson’s disease wake up feeling stiff and unable to move freely. This happens because their evening medication wears off overnight. People also frequently struggle to turn over in bed, disrupting their sleep. Current treatments are not specifically designed to release medication in the middle of the night. This trial investigates a new bedtime tablet known as CP-012. It contains two familiar Parkinson’s medicines, carbidopa and levodopa. The tablet is designed to release these medicines in stages while you sleep. The goal is to keep medicine levels steady so you can sleep more comfortably and wake up moving more easily. Participants will test two versions of the new tablet alongside a standard Parkinson's pill across three overnight clinic visits. Doctors will take blood tests and use safe, low-dose imaging scans to track how the tablet moves through the body.
At a glance
What is this study about?
Parkinson’s disease is a condition that affects the brain and body, causing symptoms like tremor, slow movements, and muscle stiffness. Many people find their symptoms are at their worst during the night and first thing in the morning. When nighttime medicine wears off, it can become hard to turn over in bed (called nocturnal immobility) or move upon waking up (called morning akinesia).
Standard Parkinson’s medications containing carbidopa and levodopa are very effective during the day, but they are not designed to release medicine hours after you fall asleep. To address this, researchers have designed a new tablet called CP-012. Taken at bedtime, it stays quiet for several hours before releasing carbidopa, followed shortly by levodopa. This step-by-step release aims to deliver medicine into your bloodstream just when your body needs it most overnight.
This early-phase trial aims to understand how the body absorbs this new tablet and how it travels through the digestive system. By comparing two different delayed-release speeds against standard medication, the research team hopes to lay the groundwork for better overnight Parkinson’s treatments in the future.
Key takeaways
- Tests a new bedtime tablet designed to release Parkinson's medicine during the night.
- Aims to reduce stiffness overnight and make moving in the morning easier.
- Requires three overnight clinic stays, gentle body scans, and blood tests.
- Open to people aged 40 to 80 who have taken levodopa for at least 3 years.
- Taking part is completely voluntary and you can withdraw at any time.
Who may be eligible?
You may be able to join this study if you are between 40 and 80 years old and have had a confirmed diagnosis of Parkinson’s disease from a neurologist. You must have been taking levodopa medication for at least three years, taking at least three doses per day, and notice that your symptoms regularly return or worsen between doses.
You will need to be mobile enough to attend appointments independently and manage overnight stays at the research clinic. Your body mass index (BMI) should be between 18 and 35 kg/m².
To take part, female participants must not be pregnant or breastfeeding. Both men and women who could potentially have children must agree to use reliable contraception or practice complete abstinence throughout the study and for a short period afterwards.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 40 and 80 years of age?
- Has a neurologist diagnosed you with Parkinson's disease?
- Have you taken levodopa for at least 3 years, with at least 3 doses a day?
- Do you regularly feel your medication wearing off between doses?
- Are you able to manage overnight stays at the research clinic?
- Is your BMI between 18 and 35 kg/m²?
What does participation involve?
Taking part involves around six visits in total. These include a pre-screening chat, a detailed health screening visit, three overnight treatment visits, and one final follow-up visit. The study is scheduled to run between October 2024 and July 2025.
During each of the three overnight visits, you will stay in the clinic and receive one of three treatments at bedtime: a 4-hour delayed tablet, a 6-hour delayed tablet, or a standard Sinemet tablet. The order you take them in is chosen at random.
To see how the new tablets move through your stomach and gut, a tiny, safe amount of a medical tracer is added to the trial pills. A special camera (gamma camera) will take pictures of your stomach. The study team will also collect regular blood samples to measure medication levels in your bloodstream.
Potential risks and benefits
Locations (1)
- Glasgow Royal InfirmaryApproximateGlasgow, Scotland
Common questions
What is morning akinesia?
Morning akinesia is the medical term for waking up feeling stiff, frozen, or unable to move smoothly because your evening medication has worn off during the night.
Is the radiation from the camera scan safe?
Yes. The amount of radiation added to track the tablet is very low and comparable to everyday medical imaging, such as standard X-rays.
Will I have to stop taking my regular Parkinson's medicine?
The study team will carefully guide you on how to take your medications during the clinic visits. You should never stop or change your usual medication without talking to the study doctors first.
Do I have to sleep at the clinic?
Yes, you will need to complete three separate overnight stays so the medical team can monitor your sleep, take scans, and check blood levels through the night.
What happens if I change my mind during the trial?
You can leave the study at any time, for any reason. Your decision will not change your relationship with your doctors or the quality of your regular NHS care.
How to find out more
Lyn Corry
Always speak to your GP or specialist before deciding to take part in a study.
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