Could a single dose ease repetitive behaviors in autism?
NCT ID NCT05999240
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This study tests whether a drug called pimavanserin can reduce rigid, repetitive behaviors in people with autism. About 30 adolescents and adults aged 12 to 40 will receive either the drug or a placebo, then switch. The goal is to see if it improves flexibility and reduces compulsive actions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant must be at least 12 years old and no greater than 40 years old. * Participants 18 years of age or older or a legally acceptable representative must be able and willing to sign an informed consent document indicating understanding of the protocol and procedures and willingness to participate in full. For a participant who is under 18 years of age, a parent or guardian must sign an informed consent document indicating understanding the protocol and procedures and willingness to participate in full. When appropriate to the participants developmental level and age, assent will be used to indicate understanding and willingness to participant. If the participant is unable to sign the assent form, the participant must provide verbal or non-verbal confirmation of willingness to continue with study procedures. Each site will abide by their respective institutional requirements regarding consent of adult informants. For adult participants at the New York site only, a parent, caregiver, or other adult informant must sign an informed consent document indicating understanding the requirements for completing their portion of the study and their willingness to participate, due to institutional human subjects requirements. * Participant must have a diagnosis of Autism Spectrum Disorder, according to DSM-5 criteria, made by a licensed study psychiatrist or psychologist and supported by the Autism Diagnostic Observation Schedule 2 (ADOS-2) completed at screening or within the past 12 months prior to screening by an appropriately trained professional. * Participant must have a Clinical Global Impression of Severity for Repetitive Behavior of 4 or greater, as rated by the study psychiatrist or psychologist at Screening and at Baseline * Participant must have a non-verbal IQ of greater than or equal to 70 as determined by the 4-subtest Wechsler Abbreviated Scale of Intelligence. * Participant must be able to speak and understand English in order to complete study measures. * Participant must live with a parent, primary caregiver, or other adult informant who can complete study measures on the basis of spending an average of at least 4 hours per day with the participant * Parent, primary caregiver, or other adult informant must speak and understand English in order to complete study measures. * Participant must be able to self-administer study medication or have parent/caregiver be able to administer study medication. * Participant must be able to swallow study medication whole with liquid. * Participant or legally acceptable representative must be willing to continue current medication(s) and behavioral intervention(s) and to not add or change medication(s) or behavioral intervention(s) over the full course of the study. Exclusion Criteria: * Participant is judged by the Investigator to be unable to perform or comply with all study specific requirements. * Participant is an employee of an investigator with direct involvement in the proposed study or other studies under the direction of a study investigator, or is a family member of an investigator. * Participant has a history of any severe or unstable psychiatric condition (e.g., schizophrenia or other psychotic disorder, bipolar disorder, major depressive disorder) that, in the opinion of the Investigator, could confound the interpretation of the study results or put the participant at undue risk. An acute episode of a mood disorder will be considered exclusionary; a participant with a history of mild to moderate mood disorder may be included in the study under the discretion of the Investigator. Other stable psychiatric conditions are permitted at the discretion of the Investigator (e.g., attention deficit hyperactivity disorder, generalized anxiety disorder, etc.). * Participant has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 3 or higher (active suicidal ideation with some intent to act, without specific plan) on the Columbia Suicide Severity Rating Scale (C-SSRS), or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening or Day 1. * Participant has met DSM-5 criteria for a substance abuse disorder within the last 6 months prior to Screening, except for disorders related to caffeine or nicotine. * Participant has a positive test for an illicit drug or cannabis at Screening or Baseline. Participants who test positive for cannabis and who have a valid prescription may be rescreened if they agree to abstain from the cannabis for the length of their participation in the study. The repeat test must be negative for them to participate in the study. * Participant is taking a serotonin reuptake inhibitor or antipsychotic medication. * Participant has had a change to psychotropic medications within the last 2 months * Participant has received electroconvulsive therapy (ECT) in the last 6 months. * Participant has received new-onset psychotherapy or has had a change in the intensity of psychotherapy within the 2 months prior to Screening. * Participant has known allergies, hypersensitivity, or intolerance to Pimavanserin or its excipients. * Participant has received an investigational drug or used an investigational medical device within 3 months before the planned start of study or is currently enrolled in an investigational study. * Participant has a body mass index (BMI) \<17 or \>40 at Screening. * Participant has a known history of long QT syndrome or family history of sudden death. * Participant has a history of myocardial infarction, unstable angina, acute coronary syndrome, or cerebrovascular accident (CVA) within the last 4 months. Has greater than NYHA Class 2 congestive heart failure or Class 2 angina pectoris, sustained ventricular tachycardia (VT), ventricular fibrillation, torsade de pointes, or syncope due to an arrhythmia. * Participant has a history of neuroleptic malignant syndrome/serotonin syndrome. * Participant has had a seizure within the past 12 months. Individuals with seizure disorders who are on stable seizure medications (i.e., without seizures in the past 12 months) are permitted at the discretion of the Investigator. * Participant is pregnant or breast-feeding, or planning to become pregnant or breastfeed while enrolled in this study or within 3 months after the last dose of study drug. * Participant has current evidence, or a history within the previous 3 months prior to screening, of a serious and/or unstable neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, that, in the opinion of the Investigator, would jeopardize the safe participation of the Participant in the study. * Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence). * Participant has a known history of a positive hepatitis C virus (HCV) or human immunodeficiency virus (HIV) test. * Participant has a Screening or Baseline ECG with a QTcF\>450ms when the QRS duration is \<120 ms or has a Screening or Baseline ECG with a QTcF\>470 ms when the QRS duration is \>120 ms. * Participant has laboratory evidence of hypothyroidism at Screening, as measured by thyroid stimulating hormone (TSH) and reflex free thyroxine (T4). If TSH is abnormal and the reflex free T4 is normal, the Participant may be enrolled. * Participant has current unstable diabetes or glycosylated hemoglobin (HbAIc) \>8% at Screening. * Participant has other clinically significant laboratory abnormalities that, in the opinion of the Investigator, would jeopardize the safe participation of the study Participant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Center for Autism and the Developing Brain
RECRUITINGWhite Plains, New York, 10605, United States
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University of Kansas, Center for Research
RECRUITINGLawrence, Kansas, 66045, United States
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