Maplight - An experimental drug to moderate behavioural symptoms in people with autism

A clinical trial to investigate the efficacy, safety and tolerability of ML-004 for treatment of the core behavioural symptoms in Autistic people

Autism

The study evaluates the safety, efficacy and tolerability of investigational drug ML-004, compared to placebo, for treatment of the core symptoms in Autistic people. The study will determine whether treatment with ML-004 results in improved social communication, as well as other aspects of autism.

Category
Neuroscience
Trial status
Recruiting
Trial phase
Phase 0
Sometimes referred to as Phase 0 trials or pilot studies, these come before Phase 1 trials and are used to test how the body responds to an experimental drug. In these studies, small doses of the new drug are given once or for a short time to a very limited number of people.

Trial contact details

Contact person
Delphine Lévy-Bencheton
Email
d.levybencheton@uq.edu.au

What you need to know

Who can take part?

Participants must:

be aged 15 to 45 years and diagnosed with Autism Spectrum Disorder
not be currently taking most psychotropic medications, including SSRI and SNRI antidepressants.
have a reasonable degree of social difficulties
have someone who lives with them or knows them very well who can attend appointments and complete questionnaires.
be able to reliably swallow oral pills
must avoid pregnancy during the study if the participant is of childbearing potential

What is involved for you?

The study treatment is a tablet taken once daily by mouth, which contains either the compound ML-004 or placebo. ML-004 has been available as a migraine treatment for several years.

The study investigations include: