Table of contents
- Clinical trials overview
- Conditions being studied
- Who can take part
- Trial phases and study design
- Main outcomes and endpoints
- Trial status and enrollment
- Safety-focused studies
Clinical trials overview
The trial data show studies investigating Trospium Chloride in several programs, often as part of KarXT, KarX-EC, or NSC001 research. These studies are looking at whether the treatment is safe and whether it helps symptoms in people with brain and mental health conditions.[1]
Most of the listed studies are Phase 3 trials, which are later-stage studies that test treatment effects in larger groups. One study is Phase 2, which is an earlier study that focuses more on safety and early signs of benefit.[1]
Conditions being studied
The trials include people with Alzheimer’s disease, agitation associated with Alzheimer’s disease, and psychosis associated with Alzheimer’s disease.[1]
Other studies include people with bipolar-I disorder who have mania or mania with mixed features, as well as people with schizophrenia and adolescents with schizophrenia.[1]
One study also focuses on cognitive impairment, which means problems with thinking, memory, or mental processing.[1]
Who can take part
Based on the trial data, the target groups include adults with mild to moderate Alzheimer’s disease, adults with agitation or psychosis linked to Alzheimer’s disease, adults with bipolar-I mania, adults with schizophrenia, and teenagers aged 13 to 17 years with schizophrenia.[1]
Some studies are open to people who are already taking mood stabilizers such as lithium, valproate, or lamotrigine, because one bipolar-I study tests KarXT as an add-on treatment.[1]
One study is an open-label extension, which means participants know what treatment they are receiving and the study continues for long-term follow-up.[1]
Trial phases and study design
Most of the trials are interventional, which means the researchers assign a treatment and then measure what happens.[1]
The Phase 3 studies include both placebo-controlled designs and open-label extension studies. A placebo is a dummy treatment with no active medicine, used for comparison.[1]
The Phase 2 study in Alzheimer’s disease is a multi-center, randomized, parallel-group, double-blind, placebo-controlled trial. Randomized means participants are put into groups by chance, and double-blind means neither the participant nor the study team knows who gets the active treatment during the study.[1]
Main outcomes and endpoints
The trials measure different primary outcomes, which are the main results the researchers want to study.[1]
For agitation in Alzheimer’s disease, the main endpoint is change in the CMAI-IPA total score, which measures agitation symptoms.[1]
For bipolar-I mania, the main endpoint is change in the Young Mania Rating Scale, or YMRS, at Week 3 or Week 5. This scale measures the severity of manic symptoms.[1]
For schizophrenia, the main outcome is change in the PANSS total score at Week 6 in one study and at Week 5 in the adolescent study. PANSS is a symptom scale used for schizophrenia.[1]
For psychosis associated with Alzheimer’s disease, the main endpoint is change in the NPI-C Hallucinations and Delusions score from baseline to the end of treatment.[1]
For cognitive impairment in Alzheimer’s disease, the main outcomes are ADAS-Cog11 and CIBIC+ at Week 24. ADAS-Cog11 measures thinking and memory, and CIBIC+ looks at overall clinical change.[1]
Trial status and enrollment
The listed studies are mostly Authorised, with two studies marked Completed and one marked Withdrawn.[1]
Enrollment ranges from 150 participants in the Phase 2 Alzheimer’s study to 602 participants in an open-label extension study for agitation in Alzheimer’s disease.[1]
This shows that the research program includes both smaller early studies and larger later-stage studies across different conditions.[1]
Safety-focused studies
Several trials focus strongly on safety and tolerability, including long-term studies in agitation associated with Alzheimer’s disease, psychosis associated with Alzheimer’s disease, schizophrenia, and bipolar-I mania.[1]
The Phase 2 Alzheimer’s study measures adverse events, serious adverse events, clinical and neurological findings, vital signs, ECG results, laboratory tests, and suicidal thoughts or behavior using the C-SSRS.[1]
The long-term extension studies track treatment-emergent adverse events, which are side effects that appear after treatment starts.[1]
Overall, the trial set is designed to learn whether Trospium Chloride-related study programs can help symptoms while remaining safe in the studied patient groups.[1]
