Active not recruitingOBSERVATIONAL

Noninterventional Study Evaluating Parkinson's Disease Diary Use

This study is for people with Parkinson's disease whose current medications aren't fully controlling their symptoms. Researchers want to find the best way for patients to use a special diary to track their Parkinson’s symptoms. They will compare two groups: one group will use the diary on three days in one week, and the other will use it on two days in each of two weeks. The study aims to see if changing how often the diary is used affects how accurately it shows changes in symptoms over time, how reliable the information is, and how easy it is for people to keep using it. This information will help doctors and patients understand Parkinson’s disease better.

At a glance

Status

Active not recruiting

Sponsor

BlueRock Therapeutics

Enrolment target

194

Start

29 Jul 2022

Estimated completion

01 Oct 2026

Parkinson's Disease

What is this study about?

Imagine you have Parkinson's disease, and sometimes your medication doesn't quite help your symptoms as much as you'd like. It can be tricky to keep track of how you're feeling and how your symptoms change day-to-day. That's where a special diary comes in – it's a tool to help you record your symptoms.

This study is trying to figure out the best way to use this Parkinson's diary. Should you write in it every day for a few days, or spread it out more? Researchers want to see if using the diary more often or less often changes how clear and accurate the picture of your Parkinson's symptoms becomes over time. It's like trying to find the perfect balance so the diary is helpful but not too much of a chore.

By understanding how different ways of using the diary affect the information gathered, doctors can get a clearer and more reliable understanding of how Parkinson's disease changes in real life. This could ultimately help in making better decisions about treatment for people with Parkinson's.

Key takeaways

The study aims to find the best way to use a Parkinson's symptom diary.
It's for people with Parkinson's whose symptoms aren't fully controlled by current medication.
Participants will record their symptoms in a diary on specific days.
The study lasts for two years with regular check-ups.
This is an observation study; no new medications or treatments are involved.
You'll continue with your standard Parkinson's care throughout.

Who may be eligible?

This study is looking for people with Parkinson's disease who are between 39 and 70 years old. You need to have had Parkinson's for at least 3 years but no more than 10 years, and your doctors must have confirmed your diagnosis.

To join, your Parkinson's symptoms should improve quite a lot when you take your levodopa medication, and you should have been on a steady dose of your Parkinson's medications for at least a month. You also need to experience at least two hours of "off" time (when your medication isn't working as well) each day.

There are some reasons why you wouldn't be able to join. For example, if you have other serious health conditions like a history of stroke or multiple sclerosis, or certain types of Parkinson's that mainly cause tremor or severe uncontrolled movements (dyskinesia). You also can't take certain medications, like some types of anti-sickness drugs, or have had certain advanced treatments for Parkinson's in the recent past.

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 39 and 70 years old?
Have you been diagnosed with Parkinson's disease for 3 to 10 years?
Do your Parkinson's symptoms improve well when you take levodopa medication?
Do you experience at least two hours of 'off' time (when medication isn't working as well) daily?
Do you have good memory and thinking skills?
Do you NOT have other serious conditions like stroke, multiple sclerosis, or severe uncontrolled movements (dyskinesia)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue with your usual Parkinson's treatments. You will be asked to complete a special Parkinson's diary. Depending on which group you are in, you'll either fill out the diary for three days in one week or for two days in each of two separate weeks for each study visit. You will have study visits at the start, then after 3, 6, 12, 18, and 24 months. During these visits, information will be collected about your movement, your quality of life, and the Parkinson's medications you are taking. The study will last for a total of two years.

Potential risks and benefits

The main benefit of taking part is contributing to a better understanding of Parkinson's disease and how to best monitor it, which could help future patients. There are no direct medical benefits specific to the new diary schedule. As this is a non-interventional study, meaning it doesn't involve new medications or procedures, the risks are generally low. The main commitment is the time taken to complete the diaries and attend the study visits. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (34)

Mayo Clinic Neurology
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Scottsdale, United States
David Geffen School of Medicine University of California Los Angeles
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Los Angeles, United States
University of California, Irvine
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Orange, United States
University of Colorado
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Aurora, United States
Movement Disorders Center of Boca Raton
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Boca Raton, United States
University of Miami Health System
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Miami, United States
Parkinson's Disease and Movement Disorders Center at Northwestern University Feinberg School of Medicine
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Chicago, United States
University of Kansas Medical Center
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Kansas City, United States
University of Louisville
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Louisville, United States
Tufts Medical Center
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Boston, United States
Mount Sinai West
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New York, United States
Weill Cornell Medicine - New York Presbyterian Hospital
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New York, United States

Common questions

What is a 'noninterventional study'?

It means you'll continue with your usual Parkinson's treatments. The study just observes and collects information, rather than trying out a new medication or treatment.

What is a Parkinson's disease diary?

It's a record you keep of your symptoms, like when you feel 'on' (medication working) or 'off' (medication effect wearing off), to help track how your Parkinson's changes.

Will I have to take new medicine?

No, you will continue with your regular Parkinson's medications and care as prescribed by your doctor.

How long will I be in the study?

The study will last for two years, with visits at the beginning and then at 3, 6, 12, 18, and 24 months.

What if I feel unwell during the study?

You should always tell your regular doctor about any health concerns. The study staff will also be there to answer questions related to your participation.