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Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium

Schizophrenia Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02831231
Study type Interventional
Source Karuna Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date September 7, 2016
Completion date October 28, 2016
View Details
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