ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)

Launched by MAPLIGHT THERAPEUTICS · Oct 5, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ML-004 to see if it can help improve social communication skills in adolescents and adults with Autism Spectrum Disorder (ASD). The trial will involve around 150 participants aged 12 to 45 who have a diagnosis of ASD and have a partner who can help report on their symptoms. Participants will be randomly assigned to receive either ML-004 or a placebo (a pill that has no active medication) for comparison.

To be eligible, participants must meet certain criteria, such as having a body mass index within a specific range and being able to swallow medication. They should not have certain medical conditions or have taken other investigational drugs recently. Throughout the study, participants can expect regular check-ins and assessments to monitor their progress and any potential side effects. This trial is currently recruiting, and it's an opportunity to contribute to research that could lead to better treatments for social communication challenges in individuals with ASD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 12 to 45 at screening
• • Has a designated care/study partner who can reliably report on symptoms
• • Has a diagnosis of Autism Spectrum Disorder (ASD)
• • Has a body mass index (BMI) 18 through 34 kg/m², inclusive
• • Full scale IQ (or equivalent) ≥55 score, with adequate verbal fluency, as determined by the Principal Investigator.
• • Psychoactive medications and adjunctive therapies are stable for 4 weeks prior to screening
• • Must be able to swallow study medication
• Exclusion Criteria:
• • Has Rett syndrome or Child Disintegrative Disorder
• • Has participated in any other study and received any other investigational medication (other than COVID-19 vaccination) or device within 60 days prior to screening
• • History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening
• • History of suicidal ideation or behavior in the past 12 months, or a positive response to C-SSRS questions 4 and/or 5
• • Systolic blood pressure ≥140 mmHg (if adult) or \>135 mmHg (if adolescent), or diastolic blood pressure ≥90 (if adult) or \>85 mmHg (if adolescent), or a clinical history of uncontrolled or severe hypertension
• • If female, is pregnant or lactating