Autism clinical trials at UCSF
5 in progress, 3 open to new patients

  • A Multi-site Comparison of Social Visual Engagement to Clinical Diagnosis for Autism Spectrum Disorder

    open to eligible people ages 16 months to 30 months

    This is an outpatient, multicenter, prospective, pivotal, double-blind, within-subject comparison trial of the Marcus Autism Center Investigational Device (MAC-ID) diagnostic procedure relative to the gold-standard (reference standard), current best practice expert clinician diagnosis (ECD) of Autism Spectrum Disorder (ASD) in children 16-30 months of age. Consecutive pediatric patients from the intended population (i.e. children 16-30 months of age) recruited from pediatric referrals and general advertisements will be the subjects of this trial. All subjects will undergo the MAC-ID diagnostic procedure (test). All subjects will also undergo the current best practice clinical diagnostic procedure, using standardized ASD diagnostic instruments and standardized developmental assessments, to produce the ECD of each child's ASD status (reference/gold standard). The study consists of a screening phase and diagnostic evaluation phase to assess the validity (sensitivity and specificity), safety, and effectiveness of the MAC-ID when used to diagnose ASD. Subjects will be enrolled in the trial for a period of 1 day. The trial will be completed in approximately 12 months. The overall study objective is to assess the safety and effectiveness of the MAC-ID to accurately diagnose ASD (primary analysis), as well as to accurately assess severity of ASD (secondary analysis) in very young pediatric subjects. The primary endpoints of this study are the diagnostic result from the MAC-ID and the diagnostic results from the ECD evaluation, both of which are either positive or negative for ASD. Each subject will undergo the Social Developmental Testing Device procedure and an examination by a clinical expert in the field of ASD diagnosis; all study center site personnel (including the expert clinicians responsible for the ECD evaluation) will be blinded to MAC-ID results.

    San Francisco, California and other locations

  • A Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Participants With Autism Spectrum Disorder (ASD)

    open to eligible people ages 5-17

    For participants enrolled prior to Version 6 of the protocol: This is a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of balovaptan in children and adolescents aged 5-17 years with ASD who are high functioning (intelligence quotient [IQ] greater than or equal to [>=] 70). For participants enrolled according to Version 6 of the protocol: This is a Phase II multi-center, randomized, double-blind, 24-week, parallel group, placebo-controlled, 2-arm study with participants assigned either to a 10 milligram (mg) or equivalent dose of balovaptan, or placebo. All other study parameters remain as stated above. All participants that complete the 24-week treatment period will be eligible to participate in an optional 52-week open-label extension (OLE) during which they will receive balovaptan treatment.

    San Francisco, California and other locations

  • Building Resilience and Appropriate Independence in Young Adults With Autism

    open to eligible people ages 18-26

    This study evaluates the effects of a 12-week life-skills resilience curriculum for young adults with autism. The project utilizes a wait-list crossover design and compares the intervention to standard care.

    San Francisco, California

  • A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension

    Sorry, not currently recruiting here

    This study will evaluate the efficacy, safety, and pharmacokinetics of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults (18 years and older) with autism spectrum disorder (ASD).

    San Francisco, California and other locations

  • An Open Label Study of CM-AT for the Treatment of Children With Autism

    Sorry, in progress, not accepting new patients

    This is a Phase III, open label extension study evaluating the continued safety and efficacy of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.

    San Francisco, California and other locations

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