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A Phase 3 Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
EU CTIS ID: 2024-520259-26-00
What this study is testing
To determine the long-term safety and tolerability of KarXT as monotherapy or as an add-on treatment for mania or mania with mixed features in bipolar-I disorder.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must be between 18-65 years old.
- Participant must have a diagnosis of Bipolar-I disorder.
- If participants are taking lithium, valproate, or lamotrigine, their dose should be stable.
- Participants must be able to understand the study and agree to take part.
You likely can't join if
- Participants cannot join if they have a high risk of suicide or violent behavior, serious heart, liver, or kidney problems, are pregnant or breastfeeding, or have recently used medicines that cannot be safely stopped
- The study excludes people with certain conditions that could be made worse by the study drug (due to its cholinergic activities), such as trouble urinating (urinary retention), stomach problems that slow digestion (gastric retention), untreated eye problems (narrow-angle glaucoma), irritable bowel syndrome, or serious constipation
- Participants will be excluded from the study if they fail a urine drug screen or alcohol test when they come in for screening.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Israel
- Argentina
- Australia
- New Zealand
- Japan
- India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Israel; Argentina; Australia; New Zealand; Japan and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.