RecruitingPHASE3INTERVENTIONAL

An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

This study is checking the long-term safety and how well people can tolerate a new medicine called KarXT. KarXT is being tested for adults with schizophrenia who haven't found enough relief from their usual antipsychotic medications. Participants in this study have already taken part in a separate but related study called ARISE (KAR-012). This new part of the study will last for 52 weeks (about one year) and aims to understand if KarXT is safe to use over a longer period. It's a 'Phase 3' study, which means it's one of the final steps before a new medicine might be considered for wider use.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Enrolment target

280

Start

07 Mar 2022

Estimated completion

19 Mar 2026

Schizophrenia

What is this study about?

This research is looking further into a new medicine called KarXT, which combines two drugs: xanomeline and trospium chloride. It's for adults with schizophrenia who are still experiencing symptoms even with their current treatment. The main goal of this particular study is to see how safe KarXT is when used over a longer period, specifically for one year. It also aims to understand if people can comfortably take the medicine for that length of time.

This study is a follow-up for people who have already been part of an earlier study called ARISE (KAR-012). If you completed the first study, you might be invited to join this longer-term extension. You would continue to take your regular antipsychotic medicine alongside KarXT.

Finding new and effective treatments for schizophrenia is very important. Studies like this help doctors and researchers understand if new medicines are not only helpful but also safe for people to use in the long run. By participating, you could help advance our understanding of potential new treatments for schizophrenia.

Key takeaways

This study is testing the long-term safety of a new medicine, KarXT, for schizophrenia.
It's for people who have already completed a previous study (KAR-012).
You will take KarXT alongside your existing schizophrenia medication.
The study lasts for about one year with regular check-ups.
A reliable friend or family member will need to assist with some study activities.
This research helps us understand potential new treatments for schizophrenia.

Who may be eligible?

To join this study, you must be between 18 and 65 years old. A key requirement is that you must have successfully finished a previous study called KAR-012 and followed all the rules of that study. You also need to be taking the same antipsychotic medicine at the same dose as you were in the previous study, and plan to continue doing so.

It's important that you live in a stable environment and are able to give your clear agreement to take part. Also, you'll need to have a reliable friend or family member (an 'informant' or 'caregiver') who can help with study activities and attend some appointments, either in person or by phone, depending on local rules.

Women who could become pregnant and men whose partners could become pregnant must agree to use effective contraception during the study and for a short time afterwards. You cannot join if the study doctor thinks there's a risk of suicidal behaviour during the 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 18 and 65 years old?
Did you successfully complete the previous ARISE (KAR-012) study?
Are you able to take the study medicine and your current antipsychotic medicine as prescribed?
Do you have a reliable friend or family member who can help with study appointments?
If you are a woman who could become pregnant, or a man whose partner could, are you willing to use effective contraception during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to take your current, stable antipsychotic medication. In addition, you will take the study medicine, KarXT, twice a day. This study is planned to last for 52 weeks, which is about one year.

You will have regular outpatient visits to the study clinic. During these visits, the study team will monitor your health, check for any side effects, and see how you are responding to the medication. They will also talk to your reliable informant/caregiver.

Throughout the study, you'll need to make sure you're taking your medicines as instructed. The study team will assess your symptoms and overall well-being. The total duration of your involvement will be approximately one year.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The main potential benefit of this study is contributing to our understanding of KarXT and helping researchers determine its long-term safety and tolerability for people with schizophrenia. There is no guarantee that you will personally benefit from taking KarXT, or that your symptoms will improve. Potential risks are possible side effects from the study medication, 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 medical care.

Locations (175)

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

Alea Research
Verified postcode
Phoenix, United States· Recruiting
Pillar Clinical Research LLC
Verified postcode
Little Rock, United States· Recruiting
Woodland International Research Group, LLC
Verified postcode
Little Rock, United States· Recruiting
Advanced Research Center, Inc.
Verified postcode
Anaheim, United States· Recruiting
CITrials - Bellflower
Verified postcode
Bellflower, United States· Recruiting
Local Institution - 110
Verified postcode
Cerritos, United States· Completed
Local Institution - 167
Verified postcode
Culver City, United States· Active not recruiting
Local Institution - 127
Verified postcode
Garden Grove, United States· Active not recruiting
Local Institution - 152
Verified postcode
La Habra, United States· Not yet recruiting
Local Institution - 126
Verified postcode
Lafayette, United States· Completed
Synergy Clinical Research of Escondido
Verified postcode
Lemon Grove, United States· Recruiting
Local Institution - 141
Verified postcode
Los Angeles, United States· Withdrawn

Common questions

What is KarXT?

KarXT is a new medicine being tested, which combines two drugs called xanomeline and trospium chloride, for people with schizophrenia.

Who can join this study?

This study is for adults aged 18-65 who have already completed a previous study called KAR-012 and are still taking their usual antipsychotic medicine.

How long does the study last?

The study will last for about one year (52 weeks).

What is the main goal of this study?

The main goal is to check the long-term safety and how well people can tolerate KarXT when used with their existing schizophrenia medication.

Do I have to stop my current medication?

No, you will keep taking your current, stable antipsychotic medication throughout the study.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

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