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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
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate pimavanserin for treatment of restricted/repetitive behavior in ASD
Evaluate the impact of a single dose of pimavanserin 34 mg versus placebo
Secondary study objectives
Explore the effects of pimavanserin on an electroencephalogram event-related potential (EEG/ERP) reversal learning test
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
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Who is running the clinical trial?
Research Foundation for Mental Hygiene, Inc.OTHER
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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.
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