Status:
RECRUITING
TB006 for Autism Spectrum Disorder
Lead Sponsor:
Rossignol Medical Center
Collaborating Sponsors:
Autism Discovery and Treatment Foundation
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
18-35 years
Phase:
PHASE2
Brief Summary
Multisite 14-week prospective double-blind placebo controlled parallel-group randomized clinical trial with 14-week open-label extension at the end of double-blind treatment phase for placebo subjects...
Detailed Description
A key molecular mechanism implicated in ASD is immune dysregulation and unchecked neuroinflammation marked by increased microglial activation. Galectin-3 (Gal-3), a galactoside-binding lectin, is crit...
Eligibility Criteria
Inclusion
- Autism Spectrum Disorder as defined below by the ADOS or ADI-R.
- Between 18 and 35 years of age at baseline.
- English included in the languages in which the individual is being raised.
- Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale.
- Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period.
- Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry.
- In males and females of childbearing age, two forms of birth control must be used unless they are not sexually active.
- A caretaker who will accompany the patient to all procedures and has adequate contact with the participant to complete caregiver questionnaires.
Exclusion
- LGALS3 rs4644 single nucleotide polymorphism with two copies of the Variant-type allele.
- History of infusion reactions to immunoglobulin product.
- Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior.
- Severely affected as defined by CGI-Severity Standard Score = 7 (Extremely Ill).
- Severe prematurity (\<34 weeks gestation) as determined by medical history.
- Current uncontrolled gastroesophageal disorders.
- Current or history of liver or kidney disease as determined by medical history and safety labs (See Laboratory Values Monitoring Plan for specific laboratory values).
- Genetic syndromes.
- Congenital brain malformations.
- Active Epilepsy Diagnosis (Epilepsy Diagnosis is defined as History of two or more unprovoked seizures; Patient with a history of epilepsy who have been off medication without seizures for more than two years do not qualify as active epilepsy).
- Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data.
- Significant negative reaction (i.e., fainting, vomiting, etc.) because of a previous blood draw.
- Failure to thrive or \< 5%ile for Body Mass Index or weight at the time of screening.
- Concurrent treatment with drug that would significantly interact with the investigational product.
- Allergy or Sensitivity to ingredients in the investigational product or placebo.
- Evaluation with the NIH Toolbox or BOSCC within 3 months of entering the study.
- Planned evaluation with the NIH Toolbox or BOSCC during the study.
- Pregnancy
- Current DSM-5 diagnosis requiring alternative pharmacotherapy, e.g., Major Depression, Bipolar Disorder, a psychotic disorder (based on clinical assessment assisted by the Child and Adolescent Symptom Inventory).
- Refusal to comply with the use of birth control if sexually active.
- Abnormal vital signs (systolic blood pressure \> 180 mmHg or \< 90 mmHg; heart rate \> 120 beats per minute or \< 55 beats per minute; temperature \> 101.0o F; oxygen saturation \< 90%)
- Prolonged QTc (defined as \> 450ms for males and \>470ms for female) or any abnormalities felt by the investigator to be of concern.
Key Trial Info
Start Date :
August 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06500637
Start Date
August 3 2024
End Date
July 31 2026
Last Update
August 15 2024
Active Locations (2)
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1
Rossignol Medical Center
Phoenix, Arizona, United States, 85050
2
Rossignol Medical Center
Aliso Viejo, California, United States, 92656