Summary

Eligibility
for people ages 12-45 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

ML-004-002 is a multi-center, randomized, double-blind, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD

Official Title

A Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).

Details

ML-004-002 is a Phase 2, multi-center, randomized, double-blind, placebo- controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective of the study will be to evaluate the efficacy of ML-004 compared with placebo for the treatment of care/study partner-reported social communication deficits in patients with ASD.

Subjects will be randomized to study treatment in a 1:1 ratio of ML-004: placebo.

Treatment will begin with 2 weeks of once daily dosing of ML-004 or placebo followed by a 9-12 day dose-titration phase until the maximum allowable tolerated dose (based on subject weight) is reached. The maximum dose tolerated during dose titration will become the maintenance dose (MD) for that subject, and the subject will remain on this dose for 12 weeks, followed by a down titration. An independent DSMC will monitor trial progress and ensure that the safety of trial subjects is not compromised.

Keywords

Autism Spectrum Disorder, ASD, Autism, social communication deficit, Autistic Disorder, Pervasive Child Development Disorders, ML-004 (IR)/(ER) tablet

Eligibility

You can join if…

Open to people ages 12-45

  • 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)
  • 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

You CAN'T join if...

  • 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 ≥160 mmHg, or diastolic blood pressure ≥100, or a clinical history of uncontrolled or severe hypertension
  • If female, is pregnant or lactating

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Southwest Autism Research & Resource Center, Clinical Research accepting new patients
    Phoenix Arizona 85006 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MapLight Therapeutics
ID
NCT05081245
Phase
Phase 2 Autism Research Study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated