Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

58-week Open-Label Trial of Tavapadon in Parkinson’s Disease (Tempo-4 Trial)

This 58-week study is for people living with Parkinson's disease. It's designed to understand how safe and well a new medicine called Tavapadon works over a longer period. Researchers will be carefully checking for any side effects and how people feel while taking the medication. They will also look at how Tavapadon might help with common Parkinson's symptoms like movement difficulties. This is a Phase 3 study, which means it’s one of the final stages of testing before a new medicine could be approved for wider use. The aim is to gather important information to see if Tavapadon could be a useful new treatment option.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Cerevel Therapeutics LLC

Enrolment target

487

Start

19 Jun 2024

Parkinson's disease

What is this study about?

This study is focused on a new medication called Tavapadon for people who have Parkinson's disease. When new medicines are developed, they go through several stages of testing to make sure they are safe and effective. This particular study is in Phase 3, which means it's a large and important stage. At this point, scientists have already done earlier tests and believe the medicine might be helpful.

The main goal of this study is to find out if Tavapadon is safe to take for a long time – in this case, for 58 weeks, which is just over a year. The researchers will be very carefully monitoring participants for any side effects, both mild and serious. They will also be looking at how many people continue taking the medication and if anyone stops due to side effects or other reasons.

Beyond safety, the study also aims to see how well Tavapadon helps with the symptoms of Parkinson's disease. This includes looking at how it affects movement, daily activities, and overall quality of life. The information gathered from this study is crucial for understanding the full picture of Tavapadon, and could help decide if it can become a new treatment option to help people manage their Parkinson's symptoms.

Key takeaways

This study is testing a new medication called Tavapadon for Parkinson's disease.
It's a long study, lasting 58 weeks, to check for long-term safety and effects.
The main goals are to see how safe Tavapadon is and if it helps with Parkinson's symptoms.
Patients aged 18 and over, of any gender, with Parkinson's disease can be considered.
Participants will have regular check-ups and assessments by the study team.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults are welcome to participate if they meet other criteria.

This study is open to everyone, regardless of whether you are male or female. The main requirement is that you have Parkinson's disease.

There will be other specific health checks and requirements that your doctor would discuss with you to make sure the study is a safe and suitable option for your particular situation.

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 18 years old or older?
Do you have Parkinson's disease?
Are you able to attend regular study appointments?
Are you willing to take a new study medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the medication Tavapadon. The study will last for 58 weeks, which is about 1 year and 2 months. During this time, you will have regular visits with the study team. These visits will involve various checks to see how you are doing.

The study team will likely check your vital signs like blood pressure and heart rate, do physical and neurological examinations, and take blood samples. You might also be asked to fill out questionnaires about your symptoms, mood, and how you are feeling generally. Some participants who take L-Dopa might also be asked to keep a diary.

There's also an interesting part where some participants might do speech and facial expression tests using their own mobile device, which could help researchers understand how the medication affects these areas. Throughout the study, the team will monitor your progress and check for any side effects.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive access to a new medication, Tavapadon, which could potentially help manage your Parkinson's symptoms. However, it's also possible that it may not help you, or you might experience side effects. The researchers will be closely monitoring your health to identify any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Germany
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Unverified
Italy
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Unverified
Spain
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Unverified
Czechia
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Unverified
Hungary
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Unverified
Bulgaria
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Unverified
Poland

Common questions

What is Parkinson's disease?

Parkinson's disease is a condition that affects the brain and can cause problems with movement, balance, and other body functions.

What is Tavapadon?

Tavapadon is a new medicine being tested to see if it can help people with Parkinson's disease. It's not yet widely available.

How long will the study last?

The study will last for about 58 weeks, which is just over a year.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.