Phase 2 Autism Spectrum Disorder Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with Autism Spectrum Disorder, confirmed by specific diagnostic assessments (ADOS or ADI-R).
• People who are between 18 and 35 years old at the start of the study.
• People who speak or were raised with English as one of their languages.
• People whose autism is rated as moderate or higher in severity (a score of 4 or above on a standard 7-point clinical rating scale).
• People who are able to keep all current therapies, diets, and behavioural treatments the same throughout the study period.
• People who have had no changes to their current therapies, diets, or behavioural treatments for at least two months before joining the study.
• People of childbearing age who are sexually active must be using two forms of birth control (this applies to both males and females).
• People who have a caregiver available to attend all study appointments and who spends enough time with the participant to complete caregiver questionnaires.

Who may not be able to join:

• People who carry two copies of a specific genetic variant known as LGALS3 rs4644 (confirm with trial site).
• People who have previously had a reaction to an immunoglobulin infusion treatment.
• People who have a history of significant self-harm, violent behaviour, or thoughts of suicide.
• People whose autism is rated at the most severe level (a score of 7, "Extremely Ill," on the clinical severity scale).
• People who were born significantly premature, before 34 weeks of pregnancy.
• People who currently have uncontrolled stomach or digestive conditions.
• People who have a current or past history of liver or kidney disease, based on medical history or lab results.
• People who have a diagnosed genetic syndrome.
• People who have a structural brain abnormality present from birth.
• People with an active epilepsy diagnosis, meaning a history of two or more unprovoked seizures. People with a past epilepsy diagnosis who have been off medication and seizure-free for more than two years would not meet this exclusion.
• People with any medical condition that the lead researcher believes could put the participant at risk or affect the reliability of the study results.
• People who have had a significant negative reaction to a blood draw in the past, such as fainting or vomiting.
• People who are not growing or gaining weight as expected, or whose body weight or BMI falls below the 5th percentile at the time of screening.
• People currently taking a medication that could significantly interact with the study drug.
• People with a known allergy or sensitivity to any ingredient in the study drug or the placebo.
• People who have completed an NIH Toolbox or BOSCC assessment within 3 months before joining the study.
• People who have a planned NIH Toolbox or BOSCC assessment scheduled during the study period.
• People who are currently pregnant.
• People who have a current diagnosis of a condition such as Major Depression, Bipolar Disorder, or a psychotic disorder that requires its own medication treatment.
• People who refuse to use birth control if they are sexually active.
• People with abnormal vital signs, such as very high or low blood pressure, abnormal heart rate, high temperature, or low oxygen levels.
• People with an abnormal heart rhythm reading (specifically a prolonged QTc interval — over 450ms for males or over 470ms for females), or any other heart rhythm concern identified by the investigator.

Important: Always verify eligibility with the trial site directly before applying.