Autism Spectrum Disorder (ASD) Clinical Trial
Official title:
A Randomized, Double-Blind, Sparing-effect Placebo Controlled, With Cross-over Study to Evaluate the Safety, Tolerability and Efficacy of SCI-210 in Children With Autism Spectrum Disorder (ASD)
To evaluate the safety and efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
The innovative compound SCI-210 consists of CBD oil combined with CannAmide (PEA formulation) using the "entourage effect" to enhance efficacy of CBD. It is believed that PEA potentiates anandamide responses in non-vascular tissues. This effect is called "entourage effect". The "entourage effect" can be achieved by enhancing the action of endogenous anandamide through an increase in the affinity for receptors and/or a decrease in enzymatic degradation of anandamide (primarily by fatty acid amide hydrolase, FAAH). Thus, the combination of CBD oil with PEA is believed to be more effective than CBD oil alone, while AEs are not increased by the addition of the natural substance PEA. SCI-210 has not been tested in clinical trials before, but anecdotal evidence of combined use of CBD and CannAmide in ASD patients has been accumulated in recent months. The evidence suggests the beneficial effects of the combination in alleviating ASD symptoms with no reported adverse events associated with the treatment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03715166 -
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 Years Old With Autism Spectrum Disorder
|
Phase 3 | |
| Completed |
NCT02803801 -
Build Your Parenting Toolkit: Guiding Children to Become Flexible Thinkers
|
N/A | |
| Recruiting |
NCT04376151 -
Guided ACT and for Adults With ASD
|
N/A | |
| Terminated |
NCT03715153 -
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.
|
Phase 3 | |
| Terminated |
NCT01592773 -
Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
|
Phase 2 | |
| Withdrawn |
NCT01395953 -
Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
|
Phase 2 | |
| Terminated |
NCT01248130 -
Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders
|
Phase 2 | |
| Completed |
NCT04860986 -
A Repeatability and Reproducibility Study of the EarliPoint™ Device
|
||
| Completed |
NCT04299464 -
A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD)
|
Phase 2 | |
| Recruiting |
NCT03392870 -
Evaluation of a Clinical Transitional Program in Autism
|
N/A | |
| Completed |
NCT01592786 -
An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
|
Phase 2 | |
| Enrolling by invitation |
NCT05187377 -
A Controlled Trial of Growth Hormone in Phelan-McDermid Syndrome and Idiopathic Autism
|
Phase 2 | |
| Completed |
NCT04631432 -
Choice Switching and Autism
|
||
| Recruiting |
NCT04578756 -
Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder
|
Phase 3 | |
| Recruiting |
NCT06443320 -
Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders
|
N/A | |
| Completed |
NCT02037022 -
Pivotal Response Treatment Package for Young Children With Autism
|
N/A | |
| Completed |
NCT01854346 -
Social Skills Group Training ("KONTAKT") for Children and Adolescent With High-functioning Autism Spectrum Disorders
|
N/A | |
| Active, not recruiting |
NCT04895215 -
AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD)
|
Phase 2 | |
| Active, not recruiting |
NCT03426826 -
The Gut-Brain Study
|
Phase 1 | |
| Completed |
NCT02384486 -
Efficacy of Training Programme to Reduce Stress
|
N/A |