Autism Spectrum Disorder Clinical Trial
Official title:
A 12-weeks, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Related Mechanism of Sulforaphane in Treatment of Autism Spectrum Disorder
NCT number | NCT02879110 |
Other study ID # | ASD201512 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | July 2019 |
Verified date | July 2019 |
Source | Central South University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this proposed study, the investigators will evaluate the the efficacy, safety and related mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or placebo group (60 patients per arm) for 12 weeks clinic trial. Clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims are to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral problems and adaptive behaviors. Biological samples also will be collected, and stored to research related mechanisms.
Status | Completed |
Enrollment | 110 |
Est. completion date | July 2019 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 15 Years |
Eligibility |
Inclusion Criteria: 1. Aged 3 to 15 years. 2. Meet DSM-V diagnostic criteria for autism spectrum disorder, and been checked with Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS). Exclusion Criteria: 1. With severe physical disease (i.e. congenital heart disease, thyroid disease, diseases with severe abnormality of liver or kidney function, diseases with abnormality vision or hearing et al.) 2. With severe central nervous system disease (i.e. epilepsy et al). 3. With other specific genetic syndromes (i.e. Fragile-X syndrome, Down's syndrome et al.) |
Country | Name | City | State |
---|---|---|---|
China | The second Xiangya hospital of central south university | Changsha | Hunan |
China | Guangzhou Huiai Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Central South University | Davis family funding, University of California, University of Illinois at Chicago |
China,
Foley AG, Cassidy AW, Regan CM. Pentyl-4-yn-VPA, a histone deacetylase inhibitor, ameliorates deficits in social behavior and cognition in a rodent model of autism spectrum disorders. Eur J Pharmacol. 2014 Mar 15;727:80-6. doi: 10.1016/j.ejphar.2014.01.050. Epub 2014 Jan 31. — View Citation
Foley AG, Gannon S, Rombach-Mullan N, Prendergast A, Barry C, Cassidy AW, Regan CM. Class I histone deacetylase inhibition ameliorates social cognition and cell adhesion molecule plasticity deficits in a rodent model of autism spectrum disorder. Neuropharmacology. 2012 Sep;63(4):750-60. doi: 10.1016/j.neuropharm.2012.05.042. Epub 2012 Jun 6. — View Citation
Houghton CA, Fassett RG, Coombes JS. Sulforaphane: translational research from laboratory bench to clinic. Nutr Rev. 2013 Nov;71(11):709-26. doi: 10.1111/nure.12060. Epub 2013 Oct 22. Review. — View Citation
Moldrich RX, Leanage G, She D, Dolan-Evans E, Nelson M, Reza N, Reutens DC. Inhibition of histone deacetylase in utero causes sociability deficits in postnatal mice. Behav Brain Res. 2013 Nov 15;257:253-64. doi: 10.1016/j.bbr.2013.09.049. Epub 2013 Oct 5. — View Citation
Montes G, Halterman JS. Association of childhood autism spectrum disorders and loss of family income. Pediatrics. 2008 Apr;121(4):e821-6. doi: 10.1542/peds.2007-1594. — View Citation
Montes G, Halterman JS. Child care problems and employment among families with preschool-aged children with autism in the United States. Pediatrics. 2008 Jul;122(1):e202-8. doi: 10.1542/peds.2007-3037. — View Citation
Mugno D, Ruta L, D'Arrigo VG, Mazzone L. Impairment of quality of life in parents of children and adolescents with pervasive developmental disorder. Health Qual Life Outcomes. 2007 Apr 27;5:22. — View Citation
Myzak MC, Tong P, Dashwood WM, Dashwood RH, Ho E. Sulforaphane retards the growth of human PC-3 xenografts and inhibits HDAC activity in human subjects. Exp Biol Med (Maywood). 2007 Feb;232(2):227-34. — View Citation
Ou JJ, Shi LJ, Xun GL, Chen C, Wu RR, Luo XR, Zhang FY, Zhao JP. Employment and financial burden of families with preschool children diagnosed with autism spectrum disorders in urban China: results from a descriptive study. BMC Psychiatry. 2015 Jan 22;15:3. doi: 10.1186/s12888-015-0382-4. — View Citation
Rossignol DA, Frye RE. A review of research trends in physiological abnormalities in autism spectrum disorders: immune dysregulation, inflammation, oxidative stress, mitochondrial dysfunction and environmental toxicant exposures. Mol Psychiatry. 2012 Apr;17(4):389-401. doi: 10.1038/mp.2011.165. Epub 2011 Dec 6. Review. — View Citation
Schieve LA, Blumberg SJ, Rice C, Visser SN, Boyle C. The relationship between autism and parenting stress. Pediatrics. 2007 Feb;119 Suppl 1:S114-21. — View Citation
Singh K, Connors SL, Macklin EA, Smith KD, Fahey JW, Talalay P, Zimmerman AW. Sulforaphane treatment of autism spectrum disorder (ASD). Proc Natl Acad Sci U S A. 2014 Oct 28;111(43):15550-5. doi: 10.1073/pnas.1416940111. Epub 2014 Oct 13. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The change of Oxidative stress indexes as tested by Oxidative stress indexes detection kit | At baseline and 12 week/endpoint | ||
Other | The change of Epigenetics indicators as tested by Epigenetics indicators | At baseline and 12 week/endpoint | ||
Other | The change of Cytokines & Chemokines as tested by Cytokines & Chemokines detection kit | At baseline and 12 week/endpoint | ||
Other | The change of Metabolites as tested by Metabolites detection kit | At baseline and 12 week/endpoint | ||
Other | The change of RNA expression as tested by RNA expression detection kit | At baseline and 12 week/endpoint | ||
Other | The change of intestinal microflora as tested by Metagenomic technique | At baseline and 12 week/endpoint | ||
Primary | The change of social impairments of children with autism spectrum disorder | Social impairments are measured by Social Responsiveness Scale | At baseline, 4 week, 8 week and 12 week/endpoint | |
Secondary | The change of rigid interests and behaviors of children with autism spectrum disorder | Rigid interests and behaviors are measured by Repetitive Behavior Scale - Revised | At baseline, 4 week, 8 week and 12 week/endpoint | |
Secondary | The change of clinical symptoms of children with autism spectrum | Clinical symptoms are measured by Aberrant Behavior Checklist | At baseline, 4 week, 8 week and 12 week/endpoint | |
Secondary | The change of other behavioral problems of children with autism spectrum | Other behavioral problems are measured by Achenbach's Child Behavior Checklist | At baseline, 4 week, 8 week and 12 week/endpoint | |
Secondary | The change of adaptive behaviors of children with autism spectrum | Adaptive behaviors are measured by Adaptive Behavior Assessment System, Second Edition | At baseline, 4 week, 8 week and 12 week/endpoint | |
Secondary | The change of clinical general impression of children with autism spectrum | Clinical general impression is measured by Ohio State University Autism Clinical Global Impression | At baseline, 4 week, 8 week and 12 week/endpoint | |
Secondary | The change of heart rate as measured by stopwatch | At baseline and 12 week/endpoint | ||
Secondary | The change of weight as measured by weighing-machine | At baseline and 12 week/endpoint | ||
Secondary | The change of height as measured by Height measurement tools | At baseline and 12 week/endpoint | ||
Secondary | The change of blood routine test as tested by clinical laboratory | At baseline and 12 week/endpoint | ||
Secondary | The change of fasting blood-glucose as tested by clinical laboratory | At baseline and 12 week/endpoint | ||
Secondary | The change of blood lipid as tested by clinical laboratory | At baseline and 12 week/endpoint | ||
Secondary | The change of liver function as tested by clinical laboratory | At baseline and 12 week/endpoint | ||
Secondary | The change of kidney function as tested by clinical laboratory | At baseline and 12 week/endpoint | ||
Secondary | The change of thyroid function as tested by clinical laboratory | At baseline and 12 week/endpoint | ||
Secondary | The change of HBV test as tested by clinical laboratory | At baseline and 12 week/endpoint | ||
Secondary | The change of helicobacter pylori test as tested by clinical laboratory | At baseline and 12 week/endpoint | ||
Secondary | The change of urine routine test as tested by clinical laboratory | At baseline and 12 week/endpoint | ||
Secondary | Number of participants with treatment-related adverse events as assessed by Systematic Assessment for Treatment Emergent Effects | At 4 week, 8 week and 12 week/endpoint |
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