RecruitingPHASE3INTERVENTIONAL

Pridopidine Phase 3 Study in Huntington's Disease

This study is investigating a new drug, pridopidine, to see if it can slow down the progression of Huntington's disease (HD) in adults and if it's safe to use. Researchers want to know if pridopidine can improve overall symptoms of HD, including daily activities, thinking skills, movement, and quality of life over one year. Some participants will receive pridopidine, while others will get a placebo (a dummy pill with no active drug). Neither the participant nor the doctors will know who is getting which. All participants will take a pill twice a day for a year and have six clinic visits. After this first year, everyone will then receive pridopidine for two more years. This will help scientists understand how well the drug works.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Prilenia

Enrolment target

400

Start

01 Jul 2026

Estimated completion

01 Jun 2030

Huntington Disease

What is this study about?

Huntington's disease (HD) is a serious condition that affects the brain, causing problems with movement, thinking, and mental health. There isn't a cure yet, so researchers are constantly looking for new treatments that can slow down its effects or improve symptoms. This study focuses on a drug called pridopidine, aiming to see if it can help people with HD.

Specifically, the researchers want to find out two main things: firstly, whether pridopidine can slow down how much HD symptoms get worse over one year. Secondly, they want to understand if it helps with specific aspects of the disease, such as a person's ability to do daily tasks, their memory and thinking skills, their control over their body movements, and their overall quality of life. By comparing pridopidine to a placebo (a pill that looks the same but contains no active drug), they can get a clear picture of its potential benefits.

This type of study is really important because it helps doctors and patients understand if a new treatment is effective and safe. The information gathered from this research could lead to new ways to manage HD and potentially improve the lives of those living with the condition. It's a key step in bringing new medicines closer to people who need them.

Key takeaways

This study explores pridopidine as a potential new treatment for Huntington's disease.
It aims to see if the drug can slow down symptoms and is safe.
Participants take a pill twice daily for three years.
The first year involves either the drug or a dummy pill; everyone gets the drug for the next two years.
Regular clinic visits and check-ups are part of participating.
Your medical care will not be affected if you choose not to join or decide to leave the study.

Who may be eligible?

To join this study, you would generally need to be an adult between 23 and 65 years old who has been diagnosed with Huntington's disease after the age of 21. Your diagnosis must be based on clear symptoms and a specific genetic test result.

There are also some medical conditions or medications that would prevent you from taking part. For example, if you have certain heart problems, a recent history of seizures, severe kidney or liver issues, or certain types of cancer, you might not be eligible. If you are pregnant, planning to become pregnant, or breastfeeding, you cannot join the study. Also, if you've recently used certain types of Huntington's disease medication or other specific drugs, you might not be able to participate.

The research team will carefully check all these details to make sure the study is safe for you and that the results will be clear and accurate. It’s important to remember that you shouldn't stop any current medication just to join this study.

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 23 and 65 years old?
Were you diagnosed with Huntington's disease (HD) after age 21?
Have you not used certain specific HD medications (called ADMs) in the last six months?
Are you not pregnant, planning to become pregnant, or breastfeeding?
Do you not have severe heart, kidney, or liver problems, or certain other serious health issues?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, here's what it would involve:

For the first year, you would take one study capsule (either pridopidine or a dummy pill) twice a day – once in the morning and once in the afternoon. During this year, you would visit the clinic six times for check-ups and tests. There will also be five phone calls with the study team to check on your safety.

After this initial year, all participants will then receive pridopidine for an additional two years. During these two years, you would continue to take pridopidine twice a day and would have six more clinic visits. The total duration of your participation in the study would be three years. Throughout the study, the medical team will be checking your health and how you're responding to the treatment.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as helping researchers find new ways to treat Huntington's disease, which could ultimately benefit you and others with the condition. While pridopidine might help slow down the disease, there's also a chance it might not work for you, or you might receive the placebo for the first year. As with any medication, there's always a possibility of side effects, which the study team will monitor closely. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (66)

The University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Not yet recruiting
University of California, San Diego
Verified postcode
La Jolla, United States· Recruiting
UCLA Medical Center
Verified postcode
Los Angeles, United States· Not yet recruiting
UC Davis Medical Center
Verified postcode
Sacramento, United States· Not yet recruiting
Georgetown University
Verified postcode
Washington D.C., United States· Not yet recruiting
University of Miami-U Health Boca Raton
Verified postcode
Boca Raton, United States· Not yet recruiting
University of Florida (Norman Fixel Institute for Neurological Diseases)
Verified postcode
Gainesville, United States· Not yet recruiting
Northwestern University
Verified postcode
Chicago, United States· Not yet recruiting
Rush University Medical Center
Verified postcode
Chicago, United States· Not yet recruiting
University of Kansas Medical Center
Verified postcode
Kansas City, United States· Not yet recruiting
Hereditary Neurological Disease Centre
Verified postcode
Wichita, United States· Recruiting
Johns Hopkins University
Verified postcode
Baltimore, United States· Not yet recruiting

Common questions

What is the main goal of this study?

The main goal is to see if the drug pridopidine can slow down how Huntington's disease gets worse and if it is safe for people to use.

What is a 'placebo'?

A placebo is a pill that looks exactly like the study drug but doesn't contain any active medicine. It helps researchers compare the real drug's effects.

How long will I be in the study?

You would be in the study for a total of three years. The first year involves either pridopidine or a placebo, followed by two more years where everyone receives pridopidine.

Will I know if I'm getting the real drug or the placebo?

For the first year, neither you nor your doctors will know if you're receiving pridopidine or the placebo. This is to ensure fair and unbiased results.

What kind of visits will I have?

You will have regular clinic visits for check-ups and tests, as well as some safety phone calls, throughout the three years of the study.

How to find out more

Prilenia Medical Information

medinfo@prilenia.com 018575745755 Official trial record

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