A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-1)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03697252 |
Recruitment Status :
Completed
First Posted : October 5, 2018
Results First Posted : September 28, 2020
Last Update Posted : October 26, 2020
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Schizophrenia |
Interventions |
Drug: Xanomeline and Trospium Chloride Capsules Drug: Placebo Capsules |
Enrollment | 182 |
Recruitment Details | The study was conducted in 12 study centers in North America. |
Pre-assignment Details | A total of 250 participants were screened, 182 were randomized, and 145 participants completed the study. |
Arm/Group Title | KarXT | Placebo |
---|---|---|
Arm/Group Description | Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period. | Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks. |
Period Title: Overall Study | ||
Started | 90 | 92 |
Completed | 72 | 73 |
Not Completed | 18 | 19 |
Reason Not Completed | ||
Adverse Event | 3 | 2 |
Withdrawal by Subject | 14 | 14 |
Lost to Follow-up | 0 | 1 |
Physician Decision | 1 | 1 |
Other | 0 | 1 |
Arm/Group Title | KarXT | Placebo | Total | |
---|---|---|---|---|
Arm/Group Description |
Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period. |
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 90 | 92 | 182 | |
Baseline Analysis Population Description |
The Intent-to-Treat (ITT) population included all participants who were randomized to the study. Participants were analyzed according to randomized treatment.
|
|||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 90 participants | 92 participants | 182 participants | |
43.4 (10.12) | 41.6 (10.08) | 42.5 (10.11) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 90 participants | 92 participants | 182 participants | |
Female |
18 20.0%
|
24 26.1%
|
42 23.1%
|
|
Male |
72 80.0%
|
68 73.9%
|
140 76.9%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 90 participants | 92 participants | 182 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
2 2.2%
|
2 2.2%
|
4 2.2%
|
|
Native Hawaiian or Other Pacific Islander |
1 1.1%
|
1 1.1%
|
2 1.1%
|
|
Black or African American |
67 74.4%
|
70 76.1%
|
137 75.3%
|
|
White |
20 22.2%
|
17 18.5%
|
37 20.3%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
2 2.2%
|
2 1.1%
|
Name/Title: | Stephen Brannan |
Organization: | Karuna Therapeutics, Inc. |
Phone: | 857-449-2234 |
EMail: | sbrannan@karunatx.com |
Responsible Party: | Karuna Therapeutics |
ClinicalTrials.gov Identifier: | NCT03697252 |
Other Study ID Numbers: |
KAR-004 |
First Submitted: | October 3, 2018 |
First Posted: | October 5, 2018 |
Results First Submitted: | September 1, 2020 |
Results First Posted: | September 28, 2020 |
Last Update Posted: | October 26, 2020 |