ML-004 for Autism

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: MapLight Therapeutics

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing the safety of a treatment called ML-004 in adolescents and adults with Autism Spectrum Disorder (ASD). The main goal is to ensure that the treatment does not cause any harmful side effects.

Eligibility Criteria

This trial is for adolescents and adults aged 12 to 45 with Autism Spectrum Disorder who finished study ML-004-002 within the last 90 days. Participants must have a stable body weight, be on consistent psychoactive medications or therapies for at least four weeks, and be able to swallow pills. They also need a reliable care partner to report on their symptoms.

Inclusion Criteria

Has completed Study ML-004-002 within the past 90 days

Has a designated care/study partner who can reliably report on symptoms

Has a diagnosis of Autism Spectrum Disorder (ASD)

+4 more

Exclusion Criteria

I have had seizures or uncontrolled epilepsy in the last 6 months.

I have severe or uncontrolled high blood pressure.

Has a positive response to C-SSRS questions 4 and/or 5, or is a significant risk for suicidal behavior

+2 more

Participant Groups

The study tests an oral medication called ML-004 in tablet form, both immediate-release (IR) and extended-release (ER), for individuals with Autism Spectrum Disorder. This extension of an earlier trial aims to gather more data about the drug's long-term effects.

1Treatment groups

Experimental Treatment

Group I: ML-004 (IR)/(ER) tabletExperimental Treatment1 Intervention

ML-004 is a bilayer immediate-release (IR)/extended-release (ER, gastroretentive) oral tablet formulation. ML-004 is taken orally once daily and provided as a tablet in two dose strengths of 12 mg (3 mg IR/9 mg ER) and 24 mg tablet (6 mg IR/18 mg ER). Dose levels for this study are 12 mg (provided as one 12 mg tablet), 24 mg (one 24 mg tablet), 48 mg (two 24 mg tablets), and 72 mg (three 24 mg tablets).