What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) that target serotonin receptors, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin inverse agonists like Pimavanserin, often have side effects including gastrointestinal issues (nausea, diarrhea), sleep disturbances (insomnia, drowsiness), and behavioral changes (irritability, agitation). Pimavanserin specifically may also cause side effects such as peripheral edema, confusion, and hallucinations. It is important to monitor these side effects closely and discuss them with a healthcare provider to ensure the benefits of the treatment outweigh the risks.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of irritability associated with Autism Spectrum Disorder (ASD), including antipsychotics like risperidone and aripiprazole. These drugs primarily target dopamine and serotonin receptors to help manage symptoms such as aggression, self-injury, and severe tantrums. While Pimavanserin, a selective serotonin inverse agonist and antagonist at 5-HT2A receptors, is being studied for its potential benefits in treating irritability in ASD, it is not yet FDA-approved for this indication. Current treatments focus on managing specific symptoms rather than the core features of ASD.

What other types of research exist?

Promising novel alternatives to Pimavanserin for treating Autism Spectrum Disorder in 2024 include: 1) Aripiprazole, a second-generation antipsychotic with a favorable safety profile, often used for irritability in ASD. 2) Brexpiprazole, another second-generation antipsychotic with fewer side effects like akathisia compared to aripiprazole. 3) Behavioral therapies such as Cognitive Behavioral Therapy (CBT) and Applied Behavior Analysis (ABA), which have shown efficacy in managing ASD symptoms. 4) Emerging gene therapies and antisense oligonucleotide therapies targeting specific genetic mutations associated with ASD.

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Serotonin Receptor Antagonist

Pimavanserin for Autism Spectrum Disorder

Phase 2 & 3

Recruiting

Research Sponsored by ACADIA Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Summary

This trial is testing pimavanserin, a medication that may help reduce irritability in children and teenagers with autism. The study focuses on kids aged 5 to 17 who have this symptom. Pimavanserin works by balancing brain chemicals to help them feel calmer. The goal is to see if the medication is safe and effective over time.

Who is the study for?

This trial is for children and adolescents aged 5 to 17 with Autism Spectrum Disorder who completed the ACP-103-069 study. Participants must be clinically stable, not at immediate risk of harm to self or others, medically stable, and females able to bear children must use effective contraception.

What is being tested?

The trial tests the long-term safety and effectiveness of Pimavanserin in treating irritability associated with ASD over a period of 52 weeks. It's an extension of a previous study where Pimavanserin was compared to a placebo.

What are the potential side effects?

Potential side effects include changes in mood or behavior, sleep disturbances, digestive issues, fatigue, weight changes. Since it's focused on long-term safety, close monitoring will occur for any other unexpected side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Therapeutic procedure

Secondary study objectives

Irritable Mood

Side effects data

From 2021 Phase 4 trial • 6 Patients • NCT04188392

33%

sleepiness

17%

weight gain

17%

diarrhea

17%

arthralgia

17%

headache

17%

skin irritation

17%

dry mouth

100%

80%

60%

40%

20%

Study treatment Arm

Open-label Treatment

Trial Design

1Treatment groups

Experimental Treatment

Group I: PimavanserinExperimental Treatment1 Intervention

Pimavanserin once daily. All patients will receive the pimavanserin low dose (patients aged 5 to 12 years: 10 mg/day pimavanserin; patients aged 13 to 17 years: 20 mg/day) the first 2 weeks of the study. Thereafter, the dose may be increased to the high dose (5 to 12 years: 20 mg/day; 13 to 17 years: 34 mg/day) based on the Investigator's assessment of clinical response. After Week 2 and up to Week 20, dose adjustments are allowed at any clinic visit based on the Investigator's assessment of clinical response and tolerability. No further dose adjustments are allowed after Week 20.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pimavanserin

2018

Completed Phase 4

~3010

Do I qualify?Apply below to find out

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) often target neurotransmitter systems to alleviate symptoms such as irritability, anxiety, and repetitive behaviors. Pimavanserin, a selective serotonin inverse agonist and antagonist at 5-HT2A receptors, works by modulating serotonin activity, which is crucial for mood and social behavior regulation. This mechanism is particularly relevant for ASD patients as it can help reduce irritability and improve social interactions. Other treatments, like SSRIs, increase serotonin levels to manage anxiety and depression, while antipsychotics may target dopamine and serotonin receptors to reduce severe behavioral issues. Understanding these mechanisms is essential for tailoring treatments to individual needs, thereby improving overall quality of life for ASD patients.

Common Defects of Spine Dynamics and Circuit Function in Neurodevelopmental Disorders: A Systematic Review of Findings From in Vivo Optical Imaging of Mouse Models.