An Open-label Extension Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Subjects With DSM-5 Schizophrenia
ClinicalTrials.gov processed this data on November 28, 2023. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED (See Contacts and Locations)Verified November 2023 by Karuna Therapeutics
Sponsor
Karuna TherapeuticsInformation Provided by (Responsible Party)
Karuna TherapeuticsClinicaltrials.gov Identifier
NCT04659174Other Study ID Numbers: KAR-008
First Submitted: December 2, 2020
First Posted: December 9, 2020
Last Update Posted: November 29, 2023
Last Verified: November 2023
History of Changes
Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.
Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.
Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.
For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.
See also the Web Policies and Notices for the NIH web site.
Study Description
Not ProvidedCondition or Disease | Intervention/Treatment |
---|---|
|
|
Study Design
Study Type | Interventional |
---|---|
Actual Enrollment | 156 participants |
Design Allocation | N/A |
Interventional Model | Single Group Assignment |
Masking | None (Open Label) |
Primary Purpose | Treatment |
Official Title | An Open-label Extension Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Subjects With DSM-5 Schizophrenia |
Study Start Date | February 1, 2021 |
Actual Primary Completion Date | October 3, 2023 |
Actual Study Completion Date | October 3, 2023 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
---|---|
|
|
Outcome Measures
Primary Outcome Measures
- Incidence of treatment-emergent adverse events (TEAEs) [From initial dose through 7 days after the final dose (up to 53 weeks)] The number and percentage of participants with TEAEs will be determined
Secondary Outcome Measures
- Incidence of serious treatment-emergent adverse events (TEAEs) [From initial dose through 7 days after the final dose (up to 53 weeks)] The number and percentage of participants with serious TEAEs will be determined
- Incidence of treatment-emergent adverse events (TEAEs) leading to withdrawal [From initial dose through 7 days after the final dose (up to 53 weeks)] The number and percentage of participants with TEAEs leading to withdrawal will be determined
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 52 [Week 52] The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 52 [Week 52] The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For positive symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 52 [Week 52] The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For negative symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Marder Factor Score [Week 52] The Negative Marder Factor score is derived from the PANSS and consists of the sum of 5 negative scales (N) and 2 general scales (G) (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance), with a minimum score of 7 and a maximum score of 49.
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 52 [Week 52] The CGI-S modified asked the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.
- Percentage of Positive and Negative Syndrome Scale (PANSS) responders (a 30% change in PANSS total score) at Week 52 [Week 52] The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A PANSS responder is defined as a participant with at least a 30% change in PANSS total score compared to baseline at Week 52.
Eligibility Criteria
Ages Eligible for Study | 18 Years to 65 Years (Adult, Older Adult) |
---|---|
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
|
Exclusion Criteria |
|
Contacts and Locations
Sponsors and Collaborators | Karuna Therapeutics |
---|---|
Locations |
|
Investigators |
More Information
Additional Relevant MeSH Terms
- Schizophrenia
- Schizophrenia Spectrum and Other Psychotic Disorders
- Mental Disorders