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Pimavanserin for Autism
Phase 2
Waitlist Available
Led By Jeremy Veenstra-VanderWeele, MD
Research Sponsored by New York State Psychiatric Institute
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 post intervention, 30 days after study completion
Awards & highlights
Study Summary
This trial tests a new drug for Autism Spectrum Disorder in participants aged 16-40. It is randomized, placebo-controlled & cross-over designed to test safety & preliminary efficacy.
Who is the study for?
This trial is for individuals aged 16-40 with Autism Spectrum Disorder, as confirmed by a licensed psychiatrist or psychologist and supported by ADOS-2. Participants must have repetitive behavior severity of moderate or above, an IQ over 70, speak English, and live with someone who can report on their behalf. They should be stable on current medications/therapies and able to take oral medication.Check my eligibility
What is being tested?
The study tests the safety and potential effectiveness of Pimavanserin Tartrate (34 Mg) compared to a placebo in treating rigid-compulsive symptoms in those with Autism Spectrum Disorder. It's a randomized, cross-over design where participants will receive both treatments at different times followed by an open label extension.See study design
What are the potential side effects?
Potential side effects of Pimavanserin may include mood changes, sleep disturbances, nausea, fatigue, irregular heart rhythm among others. The exact side effects experienced can vary from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post intervention, 30 days after study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post intervention, 30 days after study completion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate pimavanserin for treatment of restricted/repetitive behavior in ASD
Evaluate the impact of a single dose of pimavanserin 34 mg versus placebo
Secondary outcome measures
Explore the effects of pimavanserin on an electroencephalogram event-related potential (EEG/ERP) reversal learning test
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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pimavanserin tartrateExperimental Treatment1 Intervention
Pimavanserin 34 mg white to off-white capsules.
Group II: PlaceboPlacebo Group1 Intervention
Placebo to Pimavanserin tartrate
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterOTHER
462 Previous Clinical Trials
169,177 Total Patients Enrolled
Research Foundation for Mental Hygiene, Inc.OTHER
66 Previous Clinical Trials
20,888 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,054 Previous Clinical Trials
1,316,522 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I tested positive for drugs but can stop using cannabis if I have a prescription.I agree to not change my current medications or treatments during the study.I am unable to follow all the study's requirements.I or someone in my family has a history of sudden death or long QT syndrome.I don't have any serious health issues that would make it unsafe for me to join the study.My diabetes is not under control or my HbA1c level is above 8%.I have tested positive for hepatitis C or HIV.I have had a seizure in the last year or am on stable medication for seizures.I am 18 or older and willing to sign the consent form.I can swallow pills with liquid.I have not had electroconvulsive therapy in the last 6 months.I am between 16 and 40 years old.I started new psychotherapy or changed my therapy intensity within the last 2 months.I can take my medication by myself or have someone who can help me.I've had a recent heart attack or stroke, or have serious heart issues.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that's considered cured.I am currently taking medication for depression or psychosis.I have been diagnosed with Autism Spectrum Disorder by a licensed professional.
Research Study Groups:
This trial has the following groups:- Group 1: Pimavanserin tartrate
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
Does this research endeavor allow for participants who are older than 25?
"The parameters for enrollment dictate that participants within this trial must be between 16 and 40 years old. Additionally, there are 258 trials available to minors and 47 studies open to senior citizens."
Answered by AI
Are there any remaining vacancies for participants in this clinical experiment?
"At the time of writing, this clinical trial is not actively recruiting patients. The initial posting was on August 15th 2023 and the most recent edit was 2 days ago; however, 304 other medical trials currently have open recruitment programs."
Answered by AI
Would it be possible for me to join this clinical research project?
"Eligibility for this research is limited to those 16-40 years old with a diagnosis of autism spectrum disorder. Around 30 individuals will be accepted into the trial."
Answered by AI
Has the Pimavanserin tartrate molecule been sanctioned by the FDA?
"Our team at Power assessed the safety of Pimavanserin tartrate to be a 2, as Phase 2 trials provide limited evidence regarding its efficacy but some data backing up its safety."
Answered by AI
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