Is NCT06866275 recruiting in Baltimore, MD?

Yes, NCT06866275 is currently recruiting participants at its Baltimore, MD location. This autism spectrum disorder (asd) clinical trial is actively enrolling qualified participants.

How do I join the autism spectrum disorder (asd) clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Autism Spectrum Disorder (ASD) Clinical Trial in Baltimore, MD

About This Autism Spectrum Disorder (ASD) Study in Baltimore

Suramin has been found to correct the symptoms, metabolism, and brain synaptic abnormalities in two classical genetic and environmental mouse models of autism. A preliminary clinical trial (SAT-1) examined the safety and activity of a single low-dose of suramin in children with ASD and concluded suramin showed promise as a novel approach to treatment of ASD. The current study, STAT-2A, will be a randomized, double-blind, crossover, 30-week study to evaluate the preliminary proof of concept, safety, and PK of suramin sodium (KZ101) with repeat dosing by IV infusion in males 5-14 years of age who have been diagnosed with ASD. The study will be conducted at approximately 3 sites contributing approximately 15 subjects per site. Total enrollment of approximately 45 subjects is planned to achieve approximately 36 participants completing the study.

Sponsor: Children's Hospital of Orange County

Who Can Participate

Inclusion Criteria

\- Subject must meet all of the following criteria to be enrolled in this study.

Male, aged 5-14 years

Clinical diagnosis of ASD by DSM-5 criteria

ADOS-2 ≥ 7 on the comparison score for Modules 2-4 (completed within the last 2 years).

CGI-S ≥ 4 for socialization specific symptoms of ASD

Leiter-3 non-verbal IQ \> 70

Standard score \< 75 on the Socialization Domain of the Comprehensive Interview Form of the Vineland Adaptive Behavior Scale Third Edition

Subjects who are sexually active or potentially sexually active agree to use condoms with a spermicidal as a barrier method of contraception during the treatment period and for at least 30 days after the last dose of study medication

Subjects agree to wear sunscreen and to wear skin covering to the maximal degree tolerated by the child for the duration of the treatment period and for at least 30 days after the last dose of study medication

Subjects must have a ≤ 90 minutes car ride from the study site

English-speaking child and parent/guardian or caregiver

Parent or their legal guardians must be willing to sign informed consent

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from the study.

ASD diagnosis with underlying syndromic diagnosis (e.g., Fragile X, Angelman, Down's Syndrome, etc.)

≤ 5th percentile for weight

Unable to tolerate venipuncture or urine collection

Acute infection (e.g., upper respiratory tract infection, common cold, flu, strep, COVID-19)

Severe co-morbid conditions (e.g., psychosis, seizures/epilepsy uncontrolled by medication, presence of severe visual or hearing impairment) that may interact with study procedures. Controlled epilepsy is allowed providing there has not been a breakthrough seizure in the past year.

Any organ system dysfunction, especially liver (e.g., ALT or AST ≥ 1.5x the upper limit of normal), kidney (estimated glomerular filtration rate or eGFR \< 90 mL/min/1.73 m2; hematuria confirmed by urine microscopy \[ \> 5 red blood cells/high power field\]; proteinuria \[\> 1+ that does not resolve on repeat testing or urine protein to creatinine ratio \> 0.3\]; and/or presence of any granular, mixed cellular, red blood cell, white blood cell, or muddy brown casts on urine microscopy), or clinically relevant heart or adrenal abnormalities

Hospitalization within the previous 2 months from screening

Initiation or change in pharmacotherapy within previous 2 months from screening

Initiation or change in psychosocial interventions (formal behavioral, cognitive, or cognitive-behavior therapy) within previous 2 months from screening

Plan to initiate or change pharmacotherapy or psychosocial interventions during the study

Taking prescription medication that may interact adversely with KZ101 or expose the subject to increased risk of harm such as medications with plasma bound substances including sulfonamides, chlorpromazine, and anti-coagulants

Currently enrolled in another clinical study or has received any investigational treatment within 30 days of screening

Taking \> 3 medications addressing behavioral symptoms related to ASD (ie typical/atypical antipsychotics and alpha-adrenergic agonists) or comorbid medical conditions such as ADHD, anxiety, or depression. Anti-seizure medications and other medications not related to neurobehavioral symptoms do not count towards the total number of medications allowed.

History of serious dermatological reactions

History of allergy, intolerance, or photosensitivity to any drug

Unable or unwilling to adhere to study requirements

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT06866275) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Autism Spectrum Disorder (ASD) Treatment Options in Baltimore, MD

If you're searching for autism spectrum disorder (asd) treatment options in Baltimore, MD, this clinical trial (NCT06866275) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this clinical trial. You'll receive care from experienced autism spectrum disorder (asd) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all autism spectrum disorder (asd) clinical trials near you to find additional studies recruiting in your area.

Autism Spectrum Disorder (ASD) Clinical Trial in Baltimore, MD

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