ML-007C-MA-211 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered ML-007C-MA in inpatient adult participants aged 18 to 64 years with schizophrenia experiencing an acute exacerbation of psychosis. The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Matched Placebo
ML-007C-MA dosed as 210/3 mg BID
ML-007C-MA dosed as 330/6 mg QD
Clinical Site
Little Rock, Arkansas, United States
RECRUITINGClinical Site
Bellflower, California, United States
RECRUITINGClinical Site
Culver City, California, United States
RECRUITINGClinical Site
Garden Grove, California, United States
RECRUITINGClinical Site
Lemon Grove, California, United States
RECRUITINGClinical Site
Los Angeles, California, United States
RECRUITINGClinical Site
Montclair, California, United States
RECRUITINGClinical Site
Orange, California, United States
RECRUITINGClinical Site
Riverside, California, United States
RECRUITINGClinical Site
San Diego, California, United States
RECRUITING...and 15 more locations
Change From Baseline to End of Treatment in Positive and Negative Syndrome Scale (PANSS) Total Score
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.
Time frame: Baseline and End of Treatment (5 weeks)
Change From Baseline to End of Treatment in CGI-S score
The CGI-S is a clinician-rated assessment of the severity of a participant's current illness on a 7-point scale, where a higher score is associated with greater severity. Values range from 1 (not ill at all) to 7 (among the most extremely ill).
Time frame: Baseline and End of Treatment (5 weeks)
Change From Baseline to End of Treatment in PANSS-Marder positive factor score
The Positive Marder Factor score is derived from the PANSS and consists of the sum of 4 positive symptom items (P), one negative symptom item (N) and 3 general symptom items (G) (P1. Delusions; P3. Hallucinations; P5. Grandiosity; P6. Suspiciousness and persecution; N7. Stereotyped thinking; G1. Somatic concern; G9. Unusual thought content; G12. Lack of judgment and insight).
Time frame: Baseline and End of Treatment (5 weeks)
Change From Baseline to End of Treatment in PANSS-Marder negative factor score
The Negative Marder Factor score is derived from the PANSS and consists of the sum of 5 negative symptom items (N) and 2 general symptom items (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.
Time frame: Baseline and End of Treatment (5 weeks)
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