TB006 for Autism Spectrum Disorder
NCT Number: NCT06500637
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Autism Spectrum Disorder
Interventions: DRUG: TB006
Sponsor: Rossignol Medical Center
Collaborators: Autism Discovery and Treatment Foundation
Sex: ALL
Age: ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-03
Completion Date: 2026-07-31
Locations: Rossignol Medical Center, Phoenix, Arizona, 85050, United States|Rossignol Medical Center, Aliso Viejo, California, 92656, United States

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. Eligible subjects will be randomized within each site in 2:1 ratio to receive either TB006 or placebo treatment.

Primary Outcome Measures: Childhood Autism Rating Scores (CARS), The CARS is a measure of autism severity completed by a clinician. Lower Score is Better. Scores range from 15 to 60., Baseline, Week 8 and Week 14
Secondary Outcome Measures: NIH Toolbox, The NIH ToolBox is a set of short assessments for neurodevelopmental assessments. Direction of score depends on individual subtest., Baseline and Week 14|Clinical Global Impression Scale (CGI), The CGI measures the overall disease severity and change. It is completed by a clinician. Scores range from 1 to 7. Lower score is better, Baseline, Week 8 and Week 14|Social Responsiveness Scale (SRS), The SRS is a caregiver report of autism symptoms Lower Score is Better, Scores range from 30 to 90 (T-scores), Baseline, Week 8, Week 12 and Week 14|Aberrant Behavior Checklist (ABC), The ABC is a 58-item consisting five subscales: hyperactivity, irritability, social withdrawal, stereotypic behavior and inappropriate speech in children with developmental disabilities. A higher score indicates more frequent aberrant behaviors., Screening, Weeks 4, 8, 12 and 14|Major Parental Concerns, The parent nominates 2 most problematic symptoms. Responses are documented in a standardized format documenting frequency, intensity, and impact of behavior. The overall severity is rated using a CGI type scale., Baseline, Week 8, Week 12 and Week 14|Ohio State University Clinical Impressions Scale, a clinical rating of severity and improvement of 10 autism domains: social interaction, aberrant/abnormal behavior, repetitive/ritualistic behavior, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety/fears, sensory sensitivities, restricted/narrow interests, autism. Severity will be measured at baseline. Each item is rated from 1 (Normal) to 7 (Among the most severe) with a raw score range of 10-70. The raw score will be reported. Higher scores indicate more severe impairment. At the following time points, improvement will be measured. Each item is rated from 1 (Very much improved) to 7 (Very much worse) with a raw score range of 10-70. The raw score will be reported. Higher scores indicate more severe impairment., Baseline and Week 14|Vineland Adaptive Behavior Scale, A scale to assess adaptive behavior in children with developmental/intellectual disabilities. This is a 135-item parent-reported measure with ratings in the following domains: communication, daily living skills, and socialization. The frequency of each item is scaled from 0 (Never) to 2 (Usually). For each domain, there are 45 items with a maximum score of 90. Change in each domain will be measured by the change in standard score. Standard scores are calculated from the raw scores and based on age norms. A higher standard score in any domain indicates a higher level of adaptive behavior in that domain. Domain standard scores will be used to get a standard composite score. Change in adaptive behavior will be measured by the change in the standard score. A higher composite score indicates higher overall adaptive behavior ability., Baseline, Week 8 and Week 14
Other Outcome Measures: Galectin-3 levels, Gal-3 levels is generally indicative of increased oligomerization and inflammation, Baseline and Week 14