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
Qualifiers
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
Treatments tested in this trial
- ML-007C-MA
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov