This is a Phase 3b, 3-year, open-label, multi-center study in which patients with DSM-5 diagnosis of schizophrenia whose current medication(s) is not well tolerated and/or clinical symptoms are not well controlled will be switched to receive KarXT. The primary objectives of the study are to assess the long-term safety and tolerability of KarXT and assess effectiveness, persistence, and durability of effect of KarXT through the Investigator Assessment Questionnaire (IAQ) and Clinical Global Impression - Severity of Illness (CGI-S) scale in patients with a diagnosis of schizophrenia. The secondary objectives are to further assess the effectiveness using the Clinical Global Impression, Global Improvement (CGI-I), long-term safety and tolerability of KarXT, and evaluation of scores from multiple additional patient scales and assessments throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
KarXT 50 mg/20 mg BID KarXT 100mg/20 mg BID KarXT 125mg/30 mg BID
Advanced Discovery Research, LLC
Atlanta, Georgia, United States
Seven Counties Services, Inc.
Louisville, Kentucky, United States
Mid Ohio Behavioral Health
Columbus, Ohio, United States
OnSite Clinical Solutions, LLC
Rock Hill, South Carolina, United States
Integrated Clinical Research
St. George, Utah, United States
The Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Discontinuation
An Adverse Event (AE) is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening, worsens during the study, regardless of the suspected cause of the event.
Time frame: From first dose to 28 days post last dose (up to approximately 113 days)
Investigator Assessment Questionnaire (IAQ) Scores
The Investigator's Assessment Questionnaire (IAQ) evaluates all health concerns associated with antipsychotic use in patients with schizophrenia or schizoaffective disorder. The IAQ total score is defined as the sum of 10 items (positive symptoms, negative symptoms, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, EPS, cognition, energy, and mood) for a total max score of 50; each item is rated on a 5-point Likert scale (1 = Much better, 2 = Slightly better, 3 = About the same, 4 = Slightly worse, and 5 = Much worse) where higher score indicate increased health concerns.
Time frame: At visit 1, 3, 5 (Baseline, week 4, 8), and early termination visit (study day 85)
Clinical Global Impression - Severity of Illness (CGI-S) Scores
The Clinical Global Impression - Severity (CGI-S) is a rating scale completed independently by a clinician that is used to measure illness and symptom severity in subjects with mental disorders. It is used to rate the severity of a subject's illness at the time of assessment. The modified CGI-S asks the clinician 1 question: "Considering your total clinical experience, how mentally ill is the subject at this time?" The clinician's answer is 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 subjects.
Time frame: At visit 1, 2, 3, 5 (baseline, week 2, 4, 8)
The Number of Participants With Serious Treatment-Emergent Adverse Events (TESAEs)
An SAE is any untoward medical occurrence that, in the view of either the investigator or Sponsor that: * Results in death. * Is life-threatening. * Results in inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity. * Is a congenital anomaly/birth defect. * Other important medical events
Time frame: From first dose to 28 days post last dose (up to approximately 113 days)
The Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
An Adverse Event (AE) is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening, worsens during the study, regardless of the suspected cause of the event. AESIs include orthostasis and liver function test (LFT) elevations (inclusive of drug induced liver injury \[DILI\]. Orthostasis will be defined as the patient being symptomatic with at least one of the following differences in orthostatic vitals between sitting position and standing after 2 minutes: * A decrease of systolic BP of 20 mmHg or more. * A decrease in diastolic BP of 10 mmHg or more. * An increase in HR of 30 bpm or more.
Time frame: From first dose to 28 days post last dose (up to approximately 113 days)
Clinical Global Impression - Improvement (CGI-I) Score
The Clinical Global Impression - Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Clinicians are asked: "Compared to the patient's condition at baseline, this patient's \[average\] condition has...?", and they rate as: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.
Time frame: At visit 2, 3, 5 (Weeks 2, 4, 8)
Medication Satisfaction Questionnaire (MSQ) Score
The Medication Satisfaction Questionnaire (MSQ) is a single-item questionnaire that evaluates satisfaction with antipsychotic medication in schizophrenia patients rated on a 7-point scale (1 = Extremely dissatisfied, 2=Very dissatisfied, 3=Somewhat dissatisfied, 4=Neither satisfied nor dissatisfied, 5=Somewhat satisfied, 6 = Very satisfied, 7 = Extremely satisfied).
Time frame: Visit 5 (Week 8)
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