396 Participants Needed

KarXT for Schizophrenia

(ARISE Trial)

Recruiting at 246 trial locations
BD
JJ
BC
Fl
JS
MS
LS
HA
Overseen ByHaig Armen Goenjian, Site 127
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Karuna Therapeutics
Must be taking: Atypical antipsychotics
Stay on Your Current MedsYou can continue your current medications while participating
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests KarXT, a combination of two drugs, for people who haven't improved with their current treatment. KarXT aims to balance brain functions and reduce side effects. The study will look at improvements in health and daily life. KarXT has shown positive results in earlier tests.

Will I have to stop taking my current medications?

The trial requires participants to continue their current antipsychotic medications like risperidone, paliperidone, or aripiprazole. However, you may need to stop other medications that are not allowed during the study.

Is KarXT safe for humans?

KarXT, a combination of xanomeline and trospium, has been studied for safety in humans. While xanomeline alone caused severe side effects, combining it with trospium seems to reduce these effects. Common side effects of KarXT include constipation, dry mouth, and nausea.12345

How is the drug KarXT different from other schizophrenia treatments?

KarXT is unique because it targets muscarinic receptors (M1 and M4) instead of the usual dopamine D2 receptors, potentially offering a new way to treat schizophrenia with fewer side effects. It combines xanomeline, which has antipsychotic effects, with trospium to reduce side effects, making it more tolerable for patients.12567

What data supports the effectiveness of the drug KarXT for treating schizophrenia?

Research shows that KarXT, a combination of xanomeline and trospium, significantly improved symptoms in patients with schizophrenia compared to a placebo, with a notable reduction in the Positive and Negative Syndrome Scale (PANSS) score. Additionally, it showed potential benefits for cognitive impairment in schizophrenia, especially in patients with existing cognitive issues.24589

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

Adults aged 18-60 with schizophrenia, stable and not hospitalized for psychiatric issues in the last 8 weeks. They must be on certain antipsychotics without adequate symptom control, have a BMI of 18-40, and agree to use contraception if applicable. Excludes those with other primary disorders or severe substance abuse within the past year.

Inclusion Criteria

I have been on the same dose of my current antipsychotic medication for at least 8 weeks.
I have been on the same dose of my schizophrenia medication for at least 8 weeks.
I've tried an antipsychotic for 6 weeks without improvement.
See 26 more

Exclusion Criteria

Urine toxicology screen is positive for non-cannabis or non-benzodiazepine substances
I have previously been treated with KarXT.
I am diagnosed with schizophreniform or experiencing my first schizophrenia episode.
See 25 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adjunctive KarXT or placebo for 6 weeks to assess efficacy in treating inadequately controlled symptoms of schizophrenia

6 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Xanomeline and Trospium Chloride Capsules
Trial Overview The trial tests KarXT (xanomeline-trospium combo) as an add-on to current antipsychotic treatment over six weeks. It's randomized and placebo-controlled, aiming to see if it better manages schizophrenia symptoms measured by PANSS Total Score compared to a placebo.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Drug: KarXTExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Karuna Therapeutics

Lead Sponsor

Trials
17
Recruited
4,100+

Published Research Related to This Trial

A combination of xanomeline and trospium showed improved tolerability and significant antipsychotic effects in a randomized study of 182 patients with acute psychosis, with a notable reduction in symptoms as measured by the PANSS score.
The study suggests that targeting the cholinergic system may offer a new treatment avenue for schizophrenia, as the combination therapy demonstrated superior efficacy in reducing both positive and negative symptoms compared to placebo.
Xanomeline-Trospium and Muscarinic Involvement in Schizophrenia.Kidambi, N., Elsayed, OH., El-Mallakh, RS.[2023]
In a 5-week study involving 170 patients with schizophrenia, the combination treatment KarXT (xanomeline-trospium) showed significantly higher response rates compared to placebo, with 59% of patients achieving at least a 20% reduction in symptoms by week 2.
KarXT demonstrated early and sustained improvements across all symptom domains of schizophrenia, including positive and negative symptoms, with significant effects observed as early as 2 weeks into treatment.
Antipsychotic Efficacy of KarXT (Xanomeline-Trospium): Post Hoc Analysis of Positive and Negative Syndrome Scale Categorical Response Rates, Time Course of Response, and Symptom Domains of Response in a Phase 2 Study.Weiden, PJ., Breier, A., Kavanagh, S., et al.[2022]
Xanomeline, a cholinergic agonist, shows potential for improving symptoms of schizophrenia, particularly when combined with trospium, a peripheral cholinergic antagonist that may help mitigate xanomeline's adverse effects.
Initial studies of the xanomeline and trospium combination indicate promise in treating schizophrenia, with common side effects including constipation, dry mouth, and nausea, suggesting a manageable safety profile.
Xanomeline and Trospium: A Potential Fixed Drug Combination (FDC) for Schizophrenia-A Brief Review of Current Data.Singh, A.[2023]

Citations

Xanomeline-Trospium and Muscarinic Involvement in Schizophrenia. [2023]
Antipsychotic Efficacy of KarXT (Xanomeline-Trospium): Post Hoc Analysis of Positive and Negative Syndrome Scale Categorical Response Rates, Time Course of Response, and Symptom Domains of Response in a Phase 2 Study. [2022]
Xanomeline and Trospium: A Potential Fixed Drug Combination (FDC) for Schizophrenia-A Brief Review of Current Data. [2023]
Xanomeline, an M(1)/M(4) preferring muscarinic cholinergic receptor agonist, produces antipsychotic-like activity in rats and mice. [2019]
Effectiveness of KarXT (xanomeline-trospium) for cognitive impairment in schizophrenia: post hoc analyses from a randomised, double-blind, placebo-controlled phase 2 study. [2023]
Evidence of trospium's ability to mitigate cholinergic adverse events related to xanomeline: phase 1 study results. [2023]
Site-independent confirmation of primary site-based PANSS ratings in a schizophrenia trial. [2022]
Muscarinic M1 and M4 receptor agonists for schizophrenia: promising candidates for the therapeutic arsenal. [2023]
Safety and tolerability of KarXT (xanomeline-trospium) in a phase 2, randomized, double-blind, placebo-controlled study in patients with schizophrenia. [2022]
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