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ARD-501 for Autism
Phase 2
Recruiting
Led By Ann Childress, MD
Research Sponsored by Aardvark Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnostic confirmation of ASD as confirmed by gold standard clinical interview using Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria and administration of the Autism Diagnostic Observation Schedule-2, Module 3 or 4
Male study participants who are sexually active with a female partner of childbearing potential must be surgically sterilized, or agree to use highly effective methods of birth control (defined below), and not rely on barrier methods and spermicide alone, from the time of screening until 1 week after final dose of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 5
Awards & highlights
Study Summary
This trial investigates the safety of two doses of a medication in people with Autism Spectrum Disorder.
Who is the study for?
This trial is for males and females aged 17-25 with Autism Spectrum Disorder, confirmed by DSM-5 criteria and specific assessments. Participants must be in good health, understand the study, and agree to follow its rules. Sexually active participants must use effective birth control methods.Check my eligibility
What is being tested?
The study tests two different doses of ARD-501 against a placebo in people with ASD. It's blinded, meaning participants don't know what they're getting, and it uses a cross-over design so everyone gets each treatment at some point.See study design
What are the potential side effects?
While the side effects are not specified here, typical clinical trials may monitor for any adverse reactions ranging from mild (like headaches or nausea) to more serious ones depending on how the body reacts to ARD-501.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with ASD based on DSM-5 and ADOS-2.
Select...
I am a male, sexually active with a woman who can have children, and I use or agree to use effective birth control.
Select...
I am between 17 and 25 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of the incidence of Treatment-Emergent Adverse Events (TEAE)
Secondary outcome measures
Assessment of change in the Clinical Global Impression - Severity/Improvement (CGI-S/I) scale
Assessment of change on the Social Responsiveness Scale, Second Edition (SRS™-2, version-adjusted for age)
Other outcome measures
Assessment of change in Gastrointestinal Severity Index (GSI)
Assessment of change in Pain Detection Threshold (PDT) and Pain Tolerating Threshold (PTT) as measured during the Cold Pressor Test
Assessment of change on the Adaptive Behavior Assessment System (ABAS-3)
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 2: High DoseExperimental Treatment1 Intervention
ARD-501 for 7 days at 0.5 mg/kg
Group II: Phase 2: Crossover Placebo to High DoseExperimental Treatment1 Intervention
ARD-501 for 7 days at 0.5 mg/kg
Group III: Phase 1: Low DoseExperimental Treatment1 Intervention
ARD-501 for 7 days at 0.2 mg/kg
Group IV: Phase 2: Crossover High Dose to PlaceboPlacebo Group1 Intervention
Placebo for 7 days
Group V: Phase 2: PlaceboPlacebo Group1 Intervention
Placebo for 7 days
Find a Location
Who is running the clinical trial?
Aardvark Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
50 Total Patients Enrolled
Center for Psychiatry And Behavioral Medicine Inc.Industry Sponsor
1 Previous Clinical Trials
88 Total Patients Enrolled
Ann Childress, MDPrincipal InvestigatorCenter for Psychiatry and Behavioral Medicine
11 Previous Clinical Trials
1,823 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research looking for new participants at the moment?
"It seems that this clinical trial is no longer accepting participants. Initially posted on November 30th 2023, the last update was made on November 9th 2023. Nonetheless, there are still 321 other trials actively recruiting patients at present."
Answered by AI
Is it possible for individuals under 30 years of age to participate in this therapeutic trial?
"For this clinical research, participants must be between 17 and 25 years of age."
Answered by AI
Has the FDA granted authorization for Phase 1: Low Dose?
"Drawing from Phase 2 trial data, our team at Power has assessed the safety of Low Dose to be a score of two. This reflects that there is some evidence for safety but very little in terms of efficacy."
Answered by AI
For what demographic is this clinical trial best suited?
"Patients with autism spectrum disorder who fall between the age bracket of 17 to 25 are eligible to participate in this medical study. Currently, 12 individuals need be recruited for the trial."
Answered by AI
Who else is applying?
What site did they apply to?
Center for Psychiatry and Behavioral Medicine Inc
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I need help with my autism and I want to feel like there is a chance at feeling normal.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
If I am eligible how soon could I start?
PatientReceived 2+ prior treatments
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