Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

PainCart Study Evaluating the Analgesic Profile of SAGE-319

This study, called 'PainCart', is testing a new medication named SAGE-319. It aims to understand how this medication might help people who experience pain as a result of certain health conditions. These conditions are thought to involve problems with how signals are sent and received in parts of the brain, specifically those related to GABA (a natural brain chemical that helps calm things down). If these signals aren't working properly, it can lead to pain. This first stage of testing in humans, sometimes called Phase I, is about finding out how the medicine works in the body and if it's safe. It's an important step to see if SAGE-319 could eventually become a useful treatment to help manage pain for people living with these conditions.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Sage Therapeutics Inc.

Enrolment target

Start

30 May 2025

Disorders characterized by a deficit in GABAergic signaling and cerebellar circuitry.

What is this study about?

This research study, named 'PainCart', is focused on exploring a new medicine called SAGE-319. The main goal is to understand how this new medication works in the body and if it has the potential to help people who experience pain linked to specific health conditions. These conditions are thought to involve issues with how certain signals, particularly those involving a brain chemical called GABA, are processed in parts of the brain.

GABA is like a 'brake' in the brain, helping to calm down overactive signals. If there isn't enough GABA or if these signals aren't working correctly, it can sometimes lead to problems including ongoing pain. Researchers believe that SAGE-319 might be able to help correct these imbalances, potentially leading to pain relief.

This study is in its very early stages of human testing, often called Phase I. This means the researchers are mainly focused on understanding how the drug behaves in the human body, how much is needed, and if it's safe. It’s a crucial step before the medicine can be tested in more people to see how well it actually treats the condition.

Key takeaways

The study is testing a new medicine called SAGE-319 for pain.
It aims to help people with pain linked to certain brain signal issues.
This is an early-stage study (Phase I) focused on safety and how the medicine works.
Participants must be 18 or older, and both men and women can join.
You have the right to leave the study at any time.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 years or older – there is no upper age limit. The study is open to both men and women.

The study is specifically looking for people who have health conditions where it's believed that certain brain signals, particularly those involving a chemical called GABA, are not working as they should. These conditions can sometimes affect a part of the brain called the cerebellum, which is important for movement and balance.

It’s important to remember that the research team will carefully review your full medical history and current health to determine if this study is the right fit for you. Not everyone with these conditions will be able to join, as there might be other health factors or medications that would prevent safe participation.

Quick self-check

Are you 18 years old or older?
Do you have a health condition where your doctor has mentioned issues with brain signals (like GABA)?
Are you able to attend regular clinic visits?
Are you willing to potentially try a new, unproven medication?
Are you comfortable with standard medical tests like blood draws?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, it would involve several visits to a clinic over a set period. During these visits, you would receive the study medication, SAGE-319. The research team would closely monitor your health through various assessments, such as physical exams, blood tests, and questionnaires, to see how your body is responding to the medication and if your pain levels are changing. You might also have follow-up appointments after you stop taking the medication. The total length of your participation would be explained fully by the study team before you agree to join.

Potential risks and benefits

While we hope that SAGE-319 might eventually offer a new way to manage pain, being in an early-stage study means there's no guarantee you will personally benefit. Potential benefits could include pain relief or a better understanding of your condition. However, like all medicines, SAGE-319 may have side effects, which the research team will discuss with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Netherlands

Common questions

What is GABA?

GABA is a natural chemical in your brain that helps to calm down nerve activity. It's like a 'brake' for your brain's signals.

What is a Phase I study?

A Phase I study is one of the first times a new medicine is tested in people. The main goals are to check if it's safe, how it works in the body, and what dose might be best, rather than how well it treats a condition yet.

Will I definitely get pain relief if I join?

As this is an early-stage study, we can't promise that you will experience pain relief. The main purpose is to learn more about the new medicine and its effects.

How long will the study last if I participate?

The exact duration of the study for each participant will be explained by the study team, as it can vary. It will involve a set period of receiving the medication and follow-up checks.

What happens if I change my mind after joining?

You are free to leave the study at any point, for any reason, without needing to explain why. Your decision will not affect your relationship with your doctor or your future medical care.