A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia

MapLight Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Schizophrenia

Treatments: Drug: ML-007C-MA BID; Drug: Placebo; Drug: ML-007C-MA QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT07038876

ML-007C-MA-211

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Participant has a primary diagnosis of schizophrenia based on the DSM-5 criteria that is confirmed by semi-structured clinical interview (Mini International Neuropsychiatric Interview for DSM-5).
• Participant may benefit from hospitalization or is currently hospitalized due to an acute exacerbation of schizophrenia symptoms, with exacerbation onset within 2 months of Screening. If the participant is already hospitalized for acute exacerbation of schizophrenia at Screening, they must have been inpatient for less than 2 weeks at the start of Screening.
• At Screening and Baseline, schizophrenia symptoms are at least moderate in severity and persistent, as defined by the PANSS and CGI-S.
• Participant is willing and able to be confined to an inpatient setting for the study duration, follow instructions, and adhere to protocol requirements.

Key Exclusion Criteria:

• Participant has any DSM-5 disorder, other than schizophrenia, within 12 months before Screening that is primarily responsible for the current symptoms or functional impairment.
• Participant has any psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before Screening and/or current involuntary hospitalization or incarceration.
• Participant received any antipsychotic medication or prohibited therapy within the Screening Period unless discontinued before Baseline.
• Participant has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline.
• Participant is at an elevated risk of suicidal behavior.
• Participant has a known or likely allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients or has a known or likely severe allergic reaction (eg, anaphylactic reaction, angioedema) to any drug that could pose a risk to the participant in this study.
• Participant has a DSM-5 diagnosis of moderate to severe substance use disorder (except tobacco or caffeine use disorder) within the 12 months before Screening (confirmed using Mini International Neuropsychiatric Interview).
• Participation in a clinical research study involving the administration of an investigational or marketed drug, biological product, or device within 90 days of Baseline, or concomitant active participation in an investigational study involving no drug, biological product, or device. Participants who have previously participated in a study with ML-007 may not participate.
• Participant is at elevated risk of violent or destructive behavior based on participant history and investigator judgment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups, including a placebo group

ML-007C-MA 330/6 mg QD

Experimental group

Treatment:

Drug: ML-007C-MA QD

ML-007C-MA 210/3 mg BID

Experimental group

Treatment:

Drug: ML-007C-MA BID

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo