237 Participants Needed

Pimavanserin for Autism Spectrum Disorder

Recruiting at 76 trial locations
SF
PS
SF
RB
AP
LC
AD
JN
Overseen ByJennifer Nicole Tomer
Age: < 18
Sex: Any
Travel: May Be Covered
Trial Phase: Phase 2 & 3
Sponsor: ACADIA Pharmaceuticals Inc.
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing pimavanserin, a medication that may help reduce irritability, agitation, and self-harm in young individuals with autism. The study focuses on those who struggle with these challenging behaviors. Pimavanserin works by balancing brain chemicals to improve mood and behavior.

Will I have to stop taking my current medications?

The trial requires stopping certain medications, including those that target irritability, medications that affect heart rhythm, and certain enzyme inhibitors and inducers. If you're on these, you may need to stop them before joining the trial.

How is the drug Pimavanserin unique for treating Autism Spectrum Disorder?

Pimavanserin is unique because it is a selective serotonin 2A receptor inverse agonist, originally approved for treating hallucinations and delusions in Parkinson's disease psychosis, and it may offer a novel approach for Autism Spectrum Disorder by targeting serotonin pathways differently than other treatments.12345

Are You a Good Fit for This Trial?

This trial is for children and adolescents aged 5 to 17 with Autism Spectrum Disorder (ASD) who show irritability, agitation, or self-injurious behaviors. They must be able to swallow pills, have not used antipsychotic drugs before or had issues with them, and meet specific criteria for ASD diagnosis. Girls must use non-hormonal contraception if of childbearing age.

Inclusion Criteria

I, or my caregiver, understand the study and can follow its requirements.
I have either never taken antipsychotic drugs or only did for less than 2 weeks.
I am a woman who cannot get pregnant or will use effective birth control.
See 8 more

Exclusion Criteria

You are at risk of hurting yourself or others, including having suicidal thoughts.
I have been seizure-free and not taken epilepsy medication for over 6 months.
Someone in my home had COVID-19 or tested positive for it in the last month.
See 23 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pimavanserin or placebo for 6 weeks to evaluate efficacy and safety for irritability associated with ASD

6 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Pimavanserin
  • Placebo
Trial Overview The study tests the effectiveness and safety of Pimavanserin compared to a placebo over six weeks in managing irritability associated with ASD. Participants are randomly assigned to either the medication or placebo group in a double-blind manner so neither they nor the researchers know who's receiving which treatment.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Pimavanserin low doseExperimental Treatment1 Intervention
Group II: Pimavanserin high doseExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Pimavanserin is already approved in United States for the following indications:

🇺🇸
Approved in United States as Nuplazid for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

ACADIA Pharmaceuticals Inc.

Lead Sponsor

Trials
49
Recruited
11,700+
Founded
1993
Headquarters
San Diego, USA
Known For
Neurological Disorders
Top Products
Nuplazid (pimavanserin), Daybue (trofinetide)

Published Research Related to This Trial

In a study involving 12 adults with Tourette syndrome, pimavanserin treatment led to a statistically significant reduction in tic severity, with a 12% decrease in the Yale Global Tic Severity Scale score after 8 weeks, although this improvement may not be clinically significant.
Pimavanserin was found to be safe, with no serious adverse events reported, and it also showed positive effects on non-motor symptoms and quality of life, suggesting potential benefits that merit further investigation in larger trials.
Pilot Study to Evaluate Pimavanserin for the Treatment of Motor and Behavioral Symptoms of Tourette Syndrome.Billnitzer, A., Jankovic, J.[2022]
Pimavanserin is the first FDA-approved treatment for Parkinson's disease psychosis (PDP) and has been shown to be well-tolerated with minimal adverse effects and no worsening of motor symptoms, based on four randomized controlled trials.
A Phase III trial demonstrated that pimavanserin 40mg significantly improved PDP symptoms compared to placebo, with notable improvements in secondary outcomes such as caregiver burden and sleep quality, highlighting its efficacy as a treatment option for PDP.
Pimavanserin: A Novel Drug Approved to Treat Parkinson's Disease Psychosis.Kitten, AK., Hallowell, SA., Saklad, SR., et al.[2021]
Pimavanserin is a selective serotonin 2A receptor inverse agonist that has been approved in the US specifically for treating hallucinations and delusions in patients with Parkinson's disease psychosis, a condition affecting up to 60% of Parkinson's patients.
The approval of pimavanserin is significant as it provides a treatment option for a condition that has limited therapeutic alternatives and is associated with increased morbidity and mortality.
Pimavanserin: First Global Approval.Markham, A.[2022]

Citations

Pilot Study to Evaluate Pimavanserin for the Treatment of Motor and Behavioral Symptoms of Tourette Syndrome. [2022]
Pimavanserin: A Novel Drug Approved to Treat Parkinson's Disease Psychosis. [2021]
Pimavanserin: First Global Approval. [2022]
Pimavanserin for Psychotic Symptoms in People With Parkinsonism: A Second Chart Review. [2018]
Pimavanserin: novel pharmacotherapy for Parkinson's disease psychosis. [2018]
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