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New treatment option for Autism Spectrum Disorder
Official title TB006 for Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT06500637
What this study is testing
What is TB006?
TB006 is an investigational medicine, being studied as a potential treatment for autism spectrum disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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. Eligible subjects will be randomized within each site in 2:1 ratio to receive either TB006 or placebo treatment.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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...
- 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 \ 120 beats per minute or \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Aliso Viejo, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Aliso Viejo, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.