research_trials

A listing of the open clinical trials at the ANP

Autism Trial with RG7314

This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314, a vasopressin 1a (V1a) receptor antagonist, in adult patients with autism spectrum disorders.

Summary

  • Study director: Robert Hendren, DO
  • Sponsor: Hoffman-La Roche
  • Recruiting?: Yes
  • Official study title: A Multi-center, Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Proof of Concept Study to Investigate the Efficacy and Safety of RG7314 in Individuals With Autism Spectrum Disorders (ASD)
  • ClinicalTrials.gov identifier: NCT01793441
  • Conditions studied: Autistic disorder

Autism Trial with Lurasidone

The purpose of this trial is to evaluate the efficacy and safety of two fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting.

Summary

  • Study director: Robert Hendren, DO
  • Sponsor: Sunovion
  • Recruiting?: No
  • Official study title: A 6-Week Randomized, Parallel, Double-Blind, Placebo Controlled, Fixed-Dose, Multicenter Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects with Irritability Associated with Autistic Disorder
  • ClinicalTrials.gov identifier: NCT01911442
  • Conditions studied: Autistic disorder

Autism Trial with Vitamin D

The study is a 12-week, open-label trial examining the tolerability of Vitamin D replacement in children with autism spectrum disorders. The study will evaluate whether Vitamin D replacement at high doses will show improvement in the core symptoms of autism, including sociability, eye contact, anger outbursts, stimming behavior, and sleep.

Summary

  • Study director: Robert Hendren, DO
  • Sponsor: Ddrops
  • Recruiting?: No
  • Official study title: Open Label Clinical trial of Vitamin D3 Dosage Tolerability and Effect on Behavioral Measures in Children with Autism
  • ClinicalTrials.gov identifier: Pending
  • Conditions studied: Autistic disorder
  • Intervention: Vitamin D3 (cholecalciferol)
  • Phase: Phase II

JumpStart Learning to Learn

The purpose of the study is to evaluate child and parent outcomes after participation in the treatment program JumpStart Learning-to-Learn (JSLTL). JSLTL is a new approach to early intervention for autism, best characterized as a "first intervention" consisting of an intensive, full-time week of parent and child trainings.

Summary

  • Study director: Bryna Siegel, PhD
  • Sponsor: Flora Foundation
  • Recruiting?: Yes
  • Official study title: Outcomes of JumpStart Learning to Learn
  • Conditions studied: Families with children recently diagnosed with autism who have participated in an intensive early intervention parent training program (JumpStart Learning to Learn)
  • Intervention: JumpStart Learning-to-Learn (JSLTL)

Autism Trial with Digestive Enzyme CM-AT

This is a Phase 3 clinical trial of CM-AT, pancreatic enzyme, in patients aged 9–12 years with autistic disorder. It is hoped that CM-AT will help improve autistic symptoms through a positive impact on gastrointestinal function.

Summary

  • Study director: Robert Hendren, DO
  • Sponsor: Curemark, LLC
  • Recruiting?: Yes
  • Official study title: An Open-Label Extension Study of LUMINENZ-ATâ„¢ (CM-AT) in Children with Autism
  • ClinicalTrials.gov identifier: NCT00881452
  • Conditions studied: Autistic disorder
  • Intervention: CM-AT (pancreatic enzyme) is a pancreatic enzyme and is sprinkled onto food three times daily.
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