What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) include behavioral interventions, omega-3 fatty acids, and cannabinoids. Behavioral interventions generally have no direct side effects but require significant time and effort. Omega-3 fatty acids are generally well-tolerated, with common side effects including gastrointestinal distress such as nausea and diarrhea. Cannabinoids, while showing some promise in observational studies, can cause somnolence, decreased appetite, irritability, and restlessness. It is important to monitor for side effects and interactions with other prescribed therapies.

What prior FDA approvals exist?

Currently, there are no FDA-approved medications specifically for the core symptoms of Autism Spectrum Disorder (ASD). However, certain medications are approved to manage associated symptoms such as irritability. For example, Risperidone and Aripiprazole are FDA-approved for treating irritability in children and adolescents with ASD. These medications help manage symptoms like aggression, self-injury, and severe tantrums. The trial ARD-501 is evaluating a new treatment, but without specific details on its mechanism, it is challenging to directly compare it to existing treatments.

What other types of research exist?

Promising novel alternatives to ARD-501 for Autism Spectrum Disorder patients include investigational drugs and therapies currently under clinical evaluation. One such alternative is the use of genetic therapies targeting specific mutations associated with ASD. Additionally, other novel compounds or biologics that modulate neural pathways or neurotransmitter systems involved in ASD are also being explored. Patients should discuss these options with their healthcare provider to determine the most appropriate treatment based on the latest research and individual health needs.

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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

Summary

This trial tests a new medication called ARD-501 for safety and effectiveness in people with Autism Spectrum Disorder (ASD). Participants will receive the medication in two different doses to compare results. The goal is to see if ARD-501 can help improve symptoms of ASD.

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.

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.

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 below

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I have been diagnosed with ASD based on DSM-5 and ADOS-2.

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I am a male, sexually active with a woman who can have children, and I use or agree to use effective birth control.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of the incidence of Treatment-Emergent Adverse Events (TEAE)

Secondary study objectives

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 study objectives

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 Aberrant Behavior Checklist, Second Edition (ABC-2)

+2 more

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autism Spectrum Disorder (ASD) include behavioral and educational interventions, pharmacologic treatments, and integrative models. Behavioral interventions, such as Applied Behavior Analysis (ABA), work by reinforcing desired behaviors and reducing maladaptive behaviors through structured techniques. Educational interventions often involve individualized programming and a high staff-to-student ratio to address specific learning needs. Pharmacologic treatments, though not always first-line, may include medications like antipsychotics or antidepressants to manage co-occurring symptoms such as anxiety or irritability. Integrative models, such as the Early Start Denver Model (ESDM), combine behavioral techniques with developmental and relationship-based approaches to improve social communication and adaptive functioning. These treatments are crucial for ASD patients as they target core symptoms and improve overall functioning, thereby enhancing quality of life.

What are we targeting when we treat autism spectrum disorder? A systematic review of 406 clinical trials.Neural Mechanisms of Qigong Sensory Training Massage for Children With Autism Spectrum Disorder: A Feasibility Study.Anxiety and ASD: Current Progress and Ongoing Challenges.

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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

1,850 Total Patients Enrolled

~8 spots leftby Dec 2024

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