Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Double-blind randomized acetazolamide trial in normal pressure hydrocephalus (DRAIN)

The DRAIN study is a research project investigating a medicine called acetazolamide for people diagnosed with Normal Pressure Hydrocephalus (NPH). NPH can cause problems with walking, memory, and bladder control. This study aims to find out if acetazolamide can improve walking ability and how people feel day-to-day. Half of the participants will receive the active medicine, and the other half will receive a dummy pill (placebo) that looks the same, so neither they nor the doctors will know who is getting what. This helps to get a clear picture of whether the medicine is truly effective. Researchers will look closely at changes in walking and ask about quality of life. It's an early-stage study to see if this treatment shows promise.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Region Uppsala

Enrolment target

Start

25 Oct 2024

Normal pressure hydrocephalus

What is this study about?

This research study, known as DRAIN (Double-blind randomized acetazolamide trial in normal pressure hydrocephalus), is specifically designed to investigate a medicine called acetazolamide for individuals living with Normal Pressure Hydrocephalus (NPH). NPH is a condition that can affect older adults, leading to difficulties with walking, memory, and sometimes bladder control. The main goal of this study is to see if acetazolamide can help to improve these symptoms, particularly how well people walk.

The researchers will be very carefully measuring several things. The most important measurement will be how walking changes over time. This includes looking at how long it takes to walk a certain distance, how many steps are needed, and observing specific walking tests like the 'timed up-and-go' where participants stand up, walk, turn, and sit down. They will also be asking participants about their overall quality of life using questionnaires to understand how the condition and potential treatment affect their daily lives.

This is a 'Phase II' study, which means it's an early stage of research. It's about exploring whether this medicine works and if it's safe enough to be studied in larger groups of people later on. The information gathered from this study will be crucial in understanding if acetazolamide could be a helpful future treatment option for NPH.

Key takeaways

This study is testing a medicine called acetazolamide for Normal Pressure Hydrocephalus (NPH).
Its main aim is to see if the medicine improves walking ability.
Participants will receive either the real medicine or a dummy pill.
It's an early-stage study, meaning potential benefits are still being investigated.
Close monitoring of your health and symptoms will be part of taking part.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults are welcome to participate. The study is open to both men and women.

More detailed rules about who can join will be provided by the study team. These rules ensure that the study is as safe as possible for everyone involved and that the results are clear and accurate. For example, specific medical conditions or medicines you are already taking might mean you can't participate, as they could affect the study results or your safety.

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 a diagnosis of Normal Pressure Hydrocephalus?
Are you able to attend appointments at a study clinic?
Are you able to understand and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the active medicine (acetazolamide) or a dummy pill (placebo). Neither you nor your study doctor will know which one you are receiving – this is called a 'double-blind' study and helps ensure the results are unbiased. The dummy pill looks exactly like the real medicine.

You will have several visits to the study clinic for assessments. These will involve various tests to check your walking, such as timing how long it takes you to walk a certain distance or complete specific movements. You will also fill out questionnaires about how you are feeling, your quality of life, and any symptoms or side effects you might experience. Some participants might also have brain scans (MRI) and blood or spinal fluid tests. The study team will explain the full schedule of visits and assessments, as well as the total length of your participation.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as contributing valuable information that could help others with NPH in the future, and you will receive close medical attention. However, it's important to remember that as it's an early-stage study, the benefits of the medicine itself are not guaranteed, and you might receive the dummy pill. There are also potential risks, including side effects from the study medicine or discomfort from tests like blood draws or MRI scans. All potential risks will be fully explained to you before you agree to participate. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Sweden

Common questions

What is Normal Pressure Hydrocephalus (NPH)?

NPH is a condition where extra spinal fluid builds up in the brain, which can cause problems with walking, memory, and bladder control.

What is acetazolamide?

Acetazolamide is a medicine being tested in this study to see if it can help improve symptoms in people with NPH.

What is a 'dummy pill' or 'placebo'?

It's a pill that looks exactly like the study medicine but contains no active drug. It's used to compare against the real medicine to see if the treatment truly works.

Will I know if I'm getting the real medicine or the dummy pill?

No, this is a 'double-blind' study. Neither you nor your doctor will know which you are receiving until after the study is complete, to keep the results fair.

What kind of tests will I have if I join?

You'll have walking tests, fill out questionnaires about your symptoms and quality of life, and potentially have blood tests, spinal fluid tests, or brain scans (MRI).