Evaluation of Prednisone Treatment in Adult Males with Immune-Related Autism Spectrum Disorder

What this Trial Is About

Researchers are studying how prednisone affects adult males with an immune-mediated subtype of autism spectrum disorder ASD. The trial aims to understand prednisones impact on core ASD features and associated symptoms, evaluate its safety by monitoring side effects, and determine if further studies of anti-inflammatory drugs in this population are warranted. Participants are autistic adult males diagnosed with moderate to severe ASD. The study randomly assigns participants to receive either prednisone or a placebo daily for 16 weeks. The prednisone treatment includes three phases dose escalation during Weeks 1 to 5, optimal dose maintenance from Weeks 6 to 10, and gradual dose reduction from Weeks 11 to 16. Participants will attend up to five in-person visits, including screening, baseline, Week 5, Week 10, and a follow-up at Week 20 after stopping the treatment. Additionally, eight remote calls will be conducted for dose adjustments and checkups. Participants will provide blood and urine samples up to four times for safety and biomarker testing. They will complete questionnaires, keep a daily diary of medication intake and symptoms, and undergo clinical assessments during clinic visits. The main outcome measured is the difference in clinical global impression improvement ratings between prednisone and placebo groups after 10 weeks. Safety and treatment adherence are monitored throughout, with study participation lasting about 20 weeks including follow-up.

Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder