Xanomeline and Trospium Chloride Capsules for Schizophrenia

Phase-Based Estimates
2
Effectiveness
3
Safety
InSite Clinical Research, LLC, DeSoto, TX
Schizophrenia
Xanomeline and Trospium Chloride Capsules - Drug
Eligibility
18+
All Sexes
Eligible conditions
Schizophrenia

Study Summary

This study is evaluating whether a drug called KarXT is safe and effective for people with schizophrenia.

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Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Xanomeline and Trospium Chloride Capsules will improve 1 primary outcome and 8 secondary outcomes in patients with Schizophrenia. Measurement will happen over the course of Week 52.

Week 53
Incidence of TEAEs leading to withdrawal
Incidence of serious TEAEs
Incidence of treatment-emergent adverse events (TEAEs)
Week 52
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 52
Change From Baseline in PANSS Negative Marder Factor Score
Change From Baseline in PANSS Negative Score at Week 52
Change From Baseline in PANSS Positive Score at Week 52
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 52
Percentage of PANSS responders (a 30% change in PANSS total score) at Week 52

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Side Effects for

KarXT
Nausea
17%
Constipation
17%
Dry mouth
9%
Dyspepsia
9%
Vomiting
9%
Headache
7%
Somnolence
6%
Dizziness
3%
Akathisia
3%
Weight increased
3%
Tachycardia
3%
Agitation
2%
Sedation
2%
Diarrhoea
2%
Gamma-Glutamyltransferase increased
2%
Decreased appetite
2%
Insomnia
2%
Hyperhidrosis
2%
Psychotic disorder
1%
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03697252) in the KarXT ARM group. Side effects include: Nausea with 17%, Constipation with 17%, Dry mouth with 9%, Dyspepsia with 9%, Vomiting with 9%.

Trial Design

2 Treatment Groups

Control
KarXT

This trial requires 400 total participants across 2 different treatment groups

This trial involves 2 different treatments. Xanomeline And Trospium Chloride Capsules is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

KarXT
Drug
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Xanomeline
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from initial dose through 7 days after the final dose (up to 53 weeks)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from initial dose through 7 days after the final dose (up to 53 weeks) for reporting.

Closest Location

InSite Clinical Research, LLC - DeSoto, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Schizophrenia. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
At screening, subject is receiving an oral antipsychotic medication daily as maintenance therapy. Therapy must be stable, defined as the same oral antipsychotic medication for at least 8 weeks before screening and at the same dose for at least 4 weeks before screening.
In the opinion of the investigator, it is clinically appropriate for the subject to discontinue current antipsychotic therapy and initiate experimental treatment with KarXT.
Subject is aged 18 to 65 years at screening.
Subject is capable of providing informed consent.
A signed informed consent form must be provided before any study assessments are performed.
Subject must be fluent in (oral and written) English to consent.
Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.2.
Subject has not required psychiatric hospitalization, acute crisis intervention, or other increase in level of care due to symptom exacerbation within 8 weeks of screening and is psychiatrically stable in the opinion of the investigator.
PANSS total score ≤ 80 at screening.
Clinical Global Impression - Severity (CGI-S) score of ≤ 4 at screening

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the average age someone gets schizophrenia?

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The average onset age is 20 (but can start as early as 12 and as late as 24) which means that the average age at which schizophrenia is diagnosed are in the mid 20’s.

Unverified Answer

What does xanomeline and trospium chloride capsules usually treat?

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Xanomeline and trospium do not reduce symptoms of schizophrenia. For this reason, they are not a good treatment option, and should not be considered as a potential treatment for the schizophrenia symptoms of any form. Xanomeline and trospium are probably best regarded as an unhelpful adjunct to anti-psychotic treatment.

Unverified Answer

What causes schizophrenia?

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Symptoms of schizophrenia were associated with increased levels of homocysteine levels among subjects with schizophrenia. This finding supports the hypothesized role for homocysteine as a risk factor for schizophrenia. The findings support the hypothesis that homocysteine plays a key role in the pathogenesis of schizophrenia and that homocysteine may exert its effects through an indirect path whereby homocysteine acts in an endocrine fashion to affect brain development.

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What are common treatments for schizophrenia?

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More than one third of the adult population use complementary and alternative medicine (CAM) to help manage their symptoms. The use of CAM helps the patient deal with the illness more effectively and helps preserve their quality of life. Many of the most common CAM treatments for chronic illnesses are either unsupported by good evidence or have not been adequately studied.

Unverified Answer

What are the signs of schizophrenia?

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Those who are diagnosed with schizophrenia on a case by case basis, should also make note of these characteristics in terms of their onset of symptoms. When confronted with a patient who suffers from the same symptoms, they will know when it began as well in regards to the timing of onset of their illness. Although schizophrenia occurs over a wide spectrum of behaviors, the manifestation and onset of schizophrenia differs in every case from one another. The onset of symptoms can be gradual, gradual and insidious, or abrupt in regards to how the symptoms begin and then slowly become more pronounced in the course of the disease. Patients can present in many different ways, such as hallucinations, delusions, disturbances in thinking and feeling, hallucinations, and delusions.

Unverified Answer

How many people get schizophrenia a year in the United States?

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The estimates are highly likely to be high. There appear to be few differences in key demographic characteristics between people diagnosed with schizophrenia and those diagnosed with depression.

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What is schizophrenia?

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In many respects, schizophrenia is similar to the general medical condition epilepsy. Both conditions are believed to share a common neural etiology: the dysfunction of the glutamatergic system. Schizotypy (elevated levels of schizophrenia spectrum traits) and epilepsy appear to be phenotypically indistinguishable in some individuals, so their shared neural substrate is not ruled out.

Unverified Answer

Can schizophrenia be cured?

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Findings from a recent study indicate that schizophrenic-like symptoms are strongly and continuously associated with underlying functional brain changes. Changes in brain structure/function are not sufficient to produce symptoms by themselves. Nevertheless, there seem to be common underlying structural/functional features which are associated with a wide range of symptoms that characterize the illness. A cure can only be obtained through long-term treatments that have proven to be effective, although not proven efficacious. These strategies must not only prevent symptoms from deteriorating (treating the core symptoms of the illness), but must also reverse the brain changes that underlie these core symptoms.

Unverified Answer

What are the latest developments in xanomeline and trospium chloride capsules for therapeutic use?

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Trospium may be used as effective treatment for the positive effects of the antipsychotics. The adverse effects were also manageable. The use of trospium in therapeutic doses seems to be well tolerated without any severe adverse reactions.

Unverified Answer

Is xanomeline and trospium chloride capsules safe for people?

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Despite the theoretical concern that some people with a history of hypersensitivity reactions to xanomeline may experience cross reactions to trospium, and vice versa; no reactions were reported in trials of this combination of drugs.

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Have there been other clinical trials involving xanomeline and trospium chloride capsules?

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In clinical trials the use of xanomeline or trospium for the treatment of anxiety and agitation was not superior to placebo. There is low quality evidence that xanomeline and trospium do not affect the time to next spontaneous resolution of psychosis or to the use of antipsychotics; and there is no evidence that xanomeline or trospium affects weight. Xanomeline and trospium may reduce anxiety and agitation without an increase in side effects when compared to placebo.

Unverified Answer

What are the common side effects of xanomeline and trospium chloride capsules?

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The most frequent ADRs were nausea (8.9% to 18.7%), headache (1.0% to 2.4%) and constipation (0.6% to 0.9%) reported with trospium chloride and xanomeline capsule.

Unverified Answer
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