Abstract Details

Title Preliminary Report of Open Label Extension of Trial of Propranolol in Autism Spectrum Disorder

Topic Child Neurology and Developmental Neurology

Presentation(s) P8 - Poster Session 8 (8:00 AM-9:00 AM)

Poster/Presentation
Number 5-001

Objective Autism spectrum disorder (ASD) is characterized by impairments in social communication and restricted and repetitive behaviors, with a high incidence of comorbid anxiety. We are conducting a double-blinded placebo-controlled trial of the beta-adrenergic antagonist propranolol in ASD. Herein, we report preliminary results of the patients completing the open-label extension phase for the primary outcome measure of social communication and, secondarily, anxiety.

Background Propranolol is widely utilized for performance anxiety and public speaking anxiety. We previously reported single-dose psychopharmacological challenge studies revealing a significant beneficial effect of propranolol on a structured social interaction task in ASD.

Design/Methods ASD patients (age 7-24) are being enrolled, titrated up to 100mg propranolol daily in divided doses over 12-weeks (body weight adjusted in children), monitoring social interaction, and secondarily anxiety and overall ASD severity. Thirteen participants have completed a 12-week open label extension. Separate Clinician Global Clinical Impression -Severity (CGI-S) scales are reported for both social interaction and anxiety as well as overall ASD severity. Clinician Global Clinical Impressions of Improvement (CGI-I) were also assessed at 12-weeks.

Results CGI-S for social interaction was 3.85 (±0.90sdev)(1-7, 7=most severe) at baseline, decreasing to 3.46 (±0.78sdev) at week-12 (p=0.018). Additionally, CGI-I at 12-weeks was 2.80 (±1.01sdev) for social interaction (4=no change, 1=maximal improvement, 7=maximal decline). CGI-S for anxiety was 3.85 (±1.28sdev) at baseline, decreasing to 3.09 (±1.38sdev)(t(12)=2.57, p=0.012). CGI-I at 12-weeks was 2.54 (±1.21sdev) for anxiety. Overall ASD severity, CGI-S was 3.61 (±0.51sdev) at baseline, decreasing to 3.38 (±0.51sdev)(t(12)=1.48, p=0.082), and CGI-I at 12-weeks was 2.92 (±0.76sdev) for overall ASD severity.

Conclusions Preliminary analysis of the first participants to complete open label extension begins to suggest promising results for social interaction, as well as the secondary outcome of anxiety, and an initial trend for overall severity. Conclusions should not yet be drawn from these findings given this small and unblinded initial sample.

Authors/Disclosures
David Q. Beversdorf, MD, F�鶹��ýӳ�� (University of Missouri) PRESENTER	Dr. Beversdorf has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Yamo pharmaceuticals. Dr. Beversdorf has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Autism Research Institute. Dr. Beversdorf has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier (Research in Autism Spectrum Disorders). The institution of Dr. Beversdorf has received research support from Autism Research Institute. Dr. Beversdorf has received personal compensation in the range of $5,000-$9,999 for serving as a Case Consultant with Best Doctors.
	No disclosure on file
	No disclosure on file
	No disclosure on file
William Baskett	No disclosure on file
	No disclosure on file

�鶹��ýӳ��

�鶹��ýӳ��