Xolair Interventional Study in ASD Patients With Comorbid Atopy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT04535817
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Following the publication of two case studies that reported behavioral benefit in ASD patients treated with omalizumab, the investigators will conduct a pilot trial to test the proof-of-concept efficacy of omalizumab in ASD patients with comorbid atopic disease. Investigators will evaluate behavioral improvement using three questionnaires. Investigators will also perform fMRI on all subjects and obtain serum samples for quantification of immunological biomarkers. If the trial is conclusive, the investigators will conduct a larger-scale, randomized-controlled trial to further understand the pathology of allergy in this subpopulation of ASD patients and the efficacy of this intervention.

Key Dates

Start date
Jan 1, 2021
Status verified
Aug 2021
Primary completion
Jan 1, 2022
Completion
Jan 1, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group
    Subjects will receive subcutaneous treatment of 300mg of omalizumab during the 24-week treatment period. One injection will be administered every 4 weeks.

Primary Outcome Measure

Change from Baseline to Week 12 in Social Responsiveness Scale (SRS) Edition 2 [ Time Frame: Baseline and Week 12 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-

Find similar trials in Boston, MA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Beth Israel Deaconess Medical Center· Boston, MA

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