The trial is taking place at:
A

APG Research, LLC | Orlando, FL

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

M

MapLight Therapeutics

Status and phase

Enrolling
Phase 2

Conditions

Autism Spectrum Disorder

Treatments

Drug: ML-004 (IR)/(ER) tablet
Drug: ML-004 Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05081245
ML-004-002

Details and patient eligibility

About

ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of social communication deficits in subjects with ASD.

Enrollment

150 estimated patients

Sex

All

Ages

12 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 2 patient groups, including a placebo group

ML-004 (IR)/(ER) tablet
Experimental group
Description:
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).
Treatment:
Drug: ML-004 (IR)/(ER) tablet
ML-004 Placebo
Placebo Comparator group
Description:
Matched placebo oral tablets will consist of same excipients as the investigational drug but without any ML-004. Placebo taken orally once daily to match tablet number of ML-004 dose levels for 12 mg (1 tablet), 24 mg (1 tablet), 48 mg (2 tablets), and 72 mg (3 tablets).
Treatment:
Drug: ML-004 Placebo

Trial contacts and locations

31

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Central trial contact

Alexis Levine

Data sourced from clinicaltrials.gov

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