Trial reportPsychopharmacology2023
Evidence of trospium's ability to mitigate cholinergic adverse events related to xanomeline: phase 1 study results.
Trial report in Psychopharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02831231 (A Phase I, Double-Blind, Randomized, Multiple-Dose, Pilot Study Comparing Xanomeline Administered Alone to Xanomeline Administered in Combination With Trospium Chloride in Normal Healthy Volunteers), which is not on this map. Cited by 33 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I, Double-Blind, Randomized, Multiple-Dose, Pilot Study Comparing Xanomeline Administered Alone to Xanomeline Administered in Combination With Trospium Chloride in Normal Healthy Volunteers
Who cites it
33 citing papers in PubMed, 2 syntheses or guidelines pooled it, 55 citations in OpenAlex.
- Is muscarinic receptor agonist effective and tolerant for schizophrenia?BMC psychiatry · 2025Pooled it
- Does KarXT (xanomeline-trospium) represent a novel approach to schizophrenia management? A GRADE-assessed systematic review and meta-analysis of randomized controlled clinical trials.BMC psychiatry · 2025Pooled it
- Preclinical efficacy of the muscarinic agonist ML-007 in psychosis models depends on both MNeuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2026Article
- Novel drug treatments for schizophrenia.Nature reviews. Drug discovery · 2026Review
- Role of the neurotransmitter-receptor pathway in T-cell tumor immunology and cancer immunotherapy.Acta biochimica et biophysica Sinica · 2026Review
- Emerging non-DFrontiers in psychiatry · 2026Review
- From dopamine to muscarine: xanomeline-trospium (KarXT) as a novel direction in the psychopharmacotherapy of schizophrenia.Frontiers in pharmacology · 2026Review
- Targeting muscarinic receptors for treating schizophrenia.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026Review
- The mechanism of action and clinical efficacy of xanomeline-trospium in schizophrenia: A comprehensive review.Therapeutic advances in psychopharmacology · 2026Review
- A Qualitative Investigation of the Experience of Taking Xanomeline and Trospium Chloride for Schizophrenia, Part 2: Perceived Changes in Subjective Quality of Life and Medication Satisfaction.Schizophrenia bulletin open · 2026Article
- Beyond dopamine: KarXT and emerging mechanism-based therapies in schizophrenia.Frontiers in psychiatry · 2026Review
- Exploring Adjunctive Novel Therapeutic Approach of KarXT (Xanomeline-Trospium Chloride) for Managing Psychotic Symptoms in Patients With Schizophrenia and Alzheimer's Disease.Brain and behavior · 2026Review
- Xanomeline-Trospium for the Treatment of Schizophrenia.Focus (American Psychiatric Publishing) · 2025Review
- Xanomeline-Trospium: A Novel Therapeutic for the Treatment of Schizophrenia.The Annals of pharmacotherapy · 2025Review
- From betel nuts to Cobenfy: how an ancient recreational drug gave rise to a new class of schizophrenia medications.CNS spectrums · 2025Review
- Targeting muscarinic receptors in schizophrenia treatment: Novel antipsychotic xanomeline/trospium chloride.World journal of psychiatry · 2025Review
- Methods to address functional unblinding of raters in CNS trials.Translational psychiatry · 2025Article
- Xanomeline and Trospium Chloride Versus Placebo for the Treatment of Schizophrenia: A Post Hoc Analysis of Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed.Neuropsychiatric disease and treatment · 2025Article
- Overview of Novel Antipsychotic Drugs: State of the Art, New Mechanisms, and Clinical Aspects of Promising Compounds.Biomedicines · 2025Review
- Xanomeline/Trospium Chloride: First Approval.Drugs · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
rationaleThe M
objectiveTest the hypothesis that trospium can mitigate cholinergic AEs associated with xanomeline.
methodsHealthy volunteers enrolled in this phase 1 (NCT02831231), single-site, 9-day, double-blind comparison of xanomeline alone (n = 33) versus KarXT (n = 35). Rates of five prespecified cholinergic AEs (nausea, vomiting, diarrhea, excessive sweating, salivary hypersecretion) were compared between treatment arms. Vital signs, electrocardiograms (ECGs), safety laboratory values, and pharmacokinetic (PK) analyses were assessed. A self-administered visual analog scale (VAS) and clinician-administered scales were employed.
resultsCompared with xanomeline alone, KarXT reduced composite incidences of the five a priori selected cholinergic AEs by 46% and each individual AE by ≥ 29%. There were no episodes of syncope in KarXT-treated subjects; two cases occurred in the xanomeline-alone arm. The rate of postural dizziness was 11.4% in the KarXT arm versus 27.2% with xanomeline alone. ECG, vital signs, and laboratory values were not meaningfully different between treatment arms. The VAS and clinician-administered scales tended to favor KarXT. PK analysis revealed that trospium did not affect xanomeline's PK profile.
conclusionsTrospium was effective in mitigating xanomeline-related cholinergic AEs. KarXT had an improved safety profile compared with xanomeline alone.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.