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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
Trial Status
Recruiting
Trial Phase
Phase 0
Trial contact details
Contact Person
Delphine Lévy-Bencheton
Email
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:

  • Questionnaires for the participant and support person
  • Physical examination and vital signs
  • Electrocardiogram (ECG)
  • Video eye-tracking tests
  • Blood tests
  • Urine tests
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