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This study is intended to determine whether the addition of trospium chloride to xanomeline tartrate will ameliorate the peripheral cholinergic side effects that have been previously experienced with xanomeline tartrate when administered alone.
In this inpatient study, volunteers will received either xanomeline alone, or xanomeline plus trospium for 7 days. Subjects will report cholinergic side effects daily via visual analog scales, for each of nausea, vomiting, diarrhea, sweating and excessive salivation. Clinician administered scales will also be administered daily for assessment of the same cholinergic side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xanomeline plus placebo | Active Comparator | Drug: Xanomeline tartrate 75 mg TID, for 225 mg total daily dose Placebo, TID |
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| Xanomeline plus trospium | Experimental | Drug: Xanomeline tartrate 75 mg TID, for 225 mg total daily dose Drug: Trospium chloride 20 mg BID, for a 40 mg total daily dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| xanomeline tartrate | Drug | xanomeline tartrate, 75 mg capsule, TID |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean weekly maximum composite Visual Analogue Scale (VAS) score (nausea, diarrhea, sweating, salivation and vomiting combined) comparing xanomeline + placebo to xanomeline + trospium | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
Use of any vitamins, herbs, supplements, or over the counter medications are excluded within one week of enrollment, and during the course of the trial. Specifically, subjects may not take Benadryl® for one week prior and during the course of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Lukasz Biernat, PhD | Medpace, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace | Cincinnati | Ohio | 45227 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C075257 | xanomeline |
| C003330 | trospium chloride |
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| Trospium chloride | Drug | trospium chloride, over encapsulated 20 mg tablet, BID |
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