A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMapLight Therapeutics
About this trial
ML-007C-MA-212 is a 52-week open-label study designed to evaluate the long-term safety, tolerability, and effectiveness of ML-007C-MA in participants with schizophrenia who have recently completed an antecedent study (ML-007C-MA-211) or enroll directly (De Novo Cohort).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be able and willing to provide informed consent for all required study procedures.
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).
May benefit from long-term pharmacotherapy for schizophrenia, based on assessment of the investigator.
Is appropriate for an outpatient level of care and resides in a stable living situation, based on assessment of the investigator.
Disqualifiers
Has any DSM-5 disorder, other than schizophrenia, within the 12 months before Screening that is primarily responsible for the current symptoms or functional impairment.
Is discontinuing effective and well-tolerated antipsychotic therapy for the purpose of enrolling in this study.
Has received any prohibited therapy within the Screening Period unless discontinued before Baseline.
Has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline.
Trial design
Design model
Single group
Treatments tested in this trial
ML-007C-MA
DrugML-007C-MA dosed as 210/3 mg BID
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: ML-007C-MAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To assess the safety and tolerability of long-term ML-007C-MA administration in adult participants with schizophrenia
using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.
Time frame
From initial dose through end of treatment (up to 52 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov