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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
Study Summary
This trial is an open-label extension of the double-blind study, which means that all participants will receive pimavanserin for an additional 52 weeks. The purpose of this trial is to determine the long-term safety and tolerability of pimavanserin in this population.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Irritable Mood
Side 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
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
Find a Location
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 weigh less than 15 kg.I do not have any serious health issues apart from my current condition.I am not on any medication that the study does not allow, including certain psychiatric drugs, drugs that affect heart rhythm, or strong drugs that affect liver enzymes.My health status won't risk or interfere with the study if I take pimavanserin.
Research Study Groups:
This trial has the following groups:- Group 1: Pimavanserin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients of all ages being recruited for this clinical trial?
"This trial is for children aged 5 to 18 years old. Out of the 240 clinical trials that are searching for participants under the age of 18, this study is one of them."
Answered by AI
Are there specific prerequisites for volunteers in this experiment?
"This study is looking for228 participants that are currently experiencing irritability related to an autism spectrum disorder, who are also between the ages of 5-18. In order to qualify, patients must have completed the treatment period from a previous study (ACP-103-069), given consent before any procedures can be conducted, be determined not clinically unstable or at risk for suicide/self injury/property damage, and finally female participants of childbearing potential must use highly effective contraception or be unable to get pregnant."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
APG Research, LLC
ERG Clinical Research - New York, PLLC DBA Richmond Behavioral Associates
1st Allergy and Clinical Research Group, d/b/a IMUNOe Research Centers
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
3+
What questions have other patients asked about this trial?
What are the potential side effects?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
My son, Tristan, has tried all stimulants with no success. He was most recently on aripriprazole and it caused a tick so we had to stop. We and his medication management doctor are at a loss as to what to try next.
PatientReceived 2+ prior treatments
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