New: Quarterly Clinical Trial Radar
The DYNC1H1 Association periodically searches ClinicalTrials.gov for research studies that families may be interested in participating in. Each season we will select several to share with the community. This Fall’s focus: Behavioral and Developmental Disorders like Autism, ADHD, and Intellectual disability.
Interested in a different symptom set for DYNC1H1-related disorders? Let us know in the comments, and we’ll make sure to have it as a focus in future posts. In the meantime, anyone is able to search clinicaltrials.gov by condition or keyword, and we encourage families to do so.
In order to inquire about participation in a study, please follow the contact information included for each study.
Note: The DA is not involved in the following studies, and we are not providing medical advice. The goal of the Clinical Trial Radar is to make families aware of select research experiences that may be relevant to themselves or their children.
Study Name & Link: ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD), NCT05081245
Who: Ages 12-45 with diagnosis of Autism, ability to speak, and IQ above 55. Able to swallow medication. Must have been seizure-free and have had no change to medication for six months prior to participation.
Where: 40 study locations across the US, Australia, & Canada
Why: This is an interventional study, where patients will take an experimental new medication called ML-004 or a placebo. The goal of the medication is to improve social communication in patients with Autism Spectrum Disorder
Contact: MapLight Therapeutics, Clinical Trials Contact Center. Phone Number: +1 650-839-4388, Email: ML-004-002@Maplightrx.com
Study Name & Link: Future Planning and Well-Being for Individuals With Intellectual Disabilities and Family Caregivers, NCT06065527
Who: Family caregivers of individuals over 10 years old. Child must have intellectual or generalized developmental disability.
Where: Online out of New Hyde Park, New York. Must be able to speak English or Spanish.
Why: Compare the effectiveness of a web-based long-term care planning tool (Map Our Life) partnered with traditional case management services to traditional case management services partnered with an attention-control Centers for Disease Control and Prevention (CDC) sponsored website on health promotion for people with disabilities. The goal of this clinical trial is to promote long-term care (LTC) knowledge and planning among individuals with intellectual/developmental disabilities (IDD) and their family caregivers to improve social supports, health, and quality of life outcomes.
Contact: Cohen Children’s Medical Center, Contact Name: Sophia Jan, MD, MSHP, Phone Number: (516) 465-4377, Email: sjan1@northwell.edu
Study Name & Link: Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
Who: Patients Aged 5-17, with preference given for those over age 13. Must have a diagnosis of Autism Spectrum Disorder and experience heightened irritability. Patients may have secondary diagnoses of mild to moderate intellectual disability and/or ADHD and still be included in the study.
Where: 39 Locations across the United States
Why: Test the effectiveness of two doses of a new medication, Lumateperone for the treatment of irritability associated with pediatric autism.
Contact: ITI Clinical Trials, Phone Number: 646 440-9333 , Email: ITCIClinicalTrials@itci-inc.com
Study Name & Link: Comparative Effectiveness of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder
Who: Patients 4-17 years of age. No changes in medication in the four weeks prior to the study. Willing to stop taking prescribed ADHD medications for at least one week prior to the study.
Where: 12 locations across the US and Canada, all affiliated with The Autism Care Network
Why: Compare the effectiveness of three different types of ADHD medication in patients with a profile of ADHD & Autism.
Contact: Aria Dockham, MACPR, Phone Number: 614-722-0723 , Email: Aria.Dockham@nationwidechildrens.org
We hope to post 5-10 clinical trials of interest each quarter. Write in the comments if there are any facets of DYNC1H1-related disorders that you would like to see us focus on! If you participated in a trial, tell us your experience!
