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New treatment option for Schizophrenia
Official title A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia
ClinicalTrials.gov ID: NCT07459647
What this study is testing
What is ML-007C-MA?
ML-007C-MA is an investigational medicine, being studied as a potential treatment for schizophrenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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.
- Has an identified reliable informant(s) available to participate in relevant assessments. Site staff may serve as the informant if the site has had...
You likely can't join if
- Has any DSM-5 disorder, other than schizophrenia, within the 12 months before Screening that is primarily responsible for the current symptoms or...
- 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.
- Has clinically significant abnormal physical examination, ECG, or clinical safety laboratory result at Screening or Baseline.
- Has an elevated risk of suicidal behavior.
See the full eligibility criteria
- 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.
- Has an identified reliable informant(s) available to participate in relevant assessments. Site staff may serve as the informant if the site has had regular contact with the participant for \>1 year. Key
- 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.
- Has clinically significant abnormal physical examination, ECG, or clinical safety laboratory result at Screening or Baseline.
- Has an elevated risk of suicidal behavior.
- Has a known allergy to ML-007C-MA, its active ingredients or their excipients.
- 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 version 7.0.2 at Screening).
- Has an elevated risk of violent or destructive behavior, based on participant history and investigator judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Lemon Grove, California, United States
- Miami Lakes, Florida, United States
- Chicago, Illinois, United States
- Staten Island, New York, United States
- DeSoto, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lemon Grove, California, United States; Miami Lakes, Florida, United States; Chicago, Illinois, United States; Staten Island, New York, United States; DeSoto, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.