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Serotonin Inverse Agonist
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
Male or female and 5 through 17 years of age
For female patients only: unable to become pregnant or agree to use a highly effective non-hormonal method of contraception. Females of childbearing potential must have a negative pregnancy test
Timeline
Screening 28 days
Treatment 6 weeks
Follow Up 1 weeks
Awards & highlights
Study Summary
This trial studied the efficacy and safety of pimavanserin in children and adolescents with autism spectrum disorder and irritability, agitation, or self-injurious behaviors.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of Pimavanserin may include changes in heart rhythm, upset stomach, mood alterations like anxiety or depression, weight changes, fatigue, and possibly allergic reactions. The exact side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 5 and 17 years old.
Select...
I am a woman who cannot get pregnant or will use effective birth control.
Timeline
Screening ~ 28 days1 visit
Treatment ~ 6 weeks10 visits
Follow Up ~ 1 weeks1 visit
Screening ~ 28 days
Treatment ~ 6 weeks
Follow Up ~1 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline at Week 6 in caregiver-rated Aberrant Behavior Checklist (ABC) Irritability subscale score
Secondary outcome measures
Change from Baseline at Week 6 in Caregiver Strain Questionnaire (CGSQ) scores
Change from Baseline at Week 6 in Clinical Global Impression-Severity (CGI-S) of Irritability score
Change from Baseline at Week 6 in Repetitive Behavior Scale-Revised (RBS-R) scores
+6 moreSide effects data
From 2021 Phase 4 trial • 6 Patients • NCT0418839233%
sleepiness
17%
skin irritation
17%
headache
17%
arthralgia
17%
diarrhea
17%
weight gain
17%
dry mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label Treatment
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Pimavanserin low doseExperimental Treatment1 Intervention
Patients aged 5 to 12 years: 10 mg/day pimavanserin Patients aged 13 to 17 years: 20 mg/day pimavanserin
Pimavanserin given once daily, as capsule of 10 or 20 mg dose strength, respectively, according to the patient's age
Group II: Pimavanserin high doseExperimental Treatment1 Intervention
Patients aged 5 to 12 years: 20 mg/day pimavanserin Patients aged 13 to 17 years: 34 mg/day pimavanserin
Pimavanserin given once daily, as capsule of 20 or 34 mg dose strength, respectively, according to the patient's age
Group III: PlaceboPlacebo Group1 Intervention
Placebo given once daily, as one capsule matching in size and color the respective pimavanserin treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pimavanserin
2018
Completed Phase 4
~3010
Find a Location
Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
ACADIA Pharmaceuticals Inc.Lead Sponsor
46 Previous Clinical Trials
10,712 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
258 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.I am a woman who cannot get pregnant or will use effective birth control.I have been on a stable behavioral therapy for autism for at least 4 weeks.I weigh less than 15 kg.I am not taking any medication that is not allowed in the study, including certain drugs for mood, heart rhythm, or those affecting liver enzymes.I have a genetic disorder linked to autism, behavioral issues, or severe intellectual disability.My medication or its dose hasn't changed in the last 4 weeks.I have not had any serious health issues in the last 3 months.I have a history or risk of abnormal heart rhythms.I am between 5 and 17 years old.You have a high score on the irritability part of the Aberrant Behavior Checklist (ABC).You have been diagnosed with a drug or alcohol addiction in the last 6 months.You have moderate to severe irritability as assessed by the Clinical Global Impression-Severity (CGI-S) score.You cannot have any mental health conditions, except for ADHD or anxiety disorder.I am currently taking medications.My child is between 5 and 17 years old.I am willing to attend 9 office visits with my child.You can easily swallow a placebo pill during the study.I have had severe reactions to mental health medications in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Pimavanserin high dose
- Group 2: Placebo
- Group 3: Pimavanserin low dose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 28 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Weeks after you stop receiving the treatment.
Autism Spectrum Disorder Patient Testimony for trial: Trial Name: NCT05523895 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If a patient is over the age of 84, can they participate in this research?
"This specific study only allows patients that are aged 5-17 to enroll. In total, there are 240 clinical trials for children and 42 for adults over the age of 65 years old."
Answered by AI
Who does this trial include in its participants?
"This trial is recruiting 228 participants, within the ages of 5 and 17 who have irritability associated with autism spectrum disorder (asd). It is important that patients also meet the following criteria: Informed consent prior to the conduct of any study procedures, Patients (to the best of his/her ability), parent/legally accepted representative, and designated caregiver (if applicable) are able to understand the nature of the study, follow protocol requirements, and be willing to comply with study drug administration requirements, Able to swallow a test placebo capsule without difficulty, Score ≥18 on the Irritability subscale of the Aberrant Behavior"
Answered by AI
At how many facilities can people participate in this clinical trial?
"This trial is being conducted by AMR Baber Research Incorporated in Naperville, Illinois; Children's Research Institute in Washington, District of Columbia; and Eastside Therapeutic Resource, Inc. dba Core Clinical Research in Everett, Washington with 21 other research institutes nationwide."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
What state do they live in?
New York
What site did they apply to?
ERG Clinical Research - New York, PLLC DBA Richmond Behavioral Associates
Cincinnati Children's Hospital Medical Center
1st Allergy and Clinical Research Group, d/b/a IMUNOe Research Centers
Other
Why did patients apply to this trial?
My anxiety and depression are bad. Looking for solutions that will help my son with his ASD.
PatientReceived no prior treatments
My son, Tristan, has tried all the ADHD medications with no luck. We need help to improve his mood, anxiety, and ADHD symptoms.
PatientReceived 2+ prior treatments
My adult autistic son has been agitated a lot lately. It comes and goes, but it is scary when it happens. He self-harms. He used to harm me. His father died recently, at age 48, out of the blue, in his sleep while our son was visiting. And my mother lived with us until her Alzheimer's got too bad. She also died recently. We've tried typical anti-psychotics, both of which made him actually psychotic. He needs help that will help. Plus, he loves to go to see doctos, so even if it is placbo, he will have some fun.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
What’s involved? Can I do it from home? Is this trial will with help my son of his ASD?
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- Relaro Medical Trials, LLC: < 48 hours
Typically responds via
Phone Call
Average response time
- < 2 Days
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