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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder

A Target Engagement Study of Pimavanserin for Behavioral Inflexibility With Open Label Trial for Rigid Rigid-compulsive Behavior in Adolescents and Adults With Autism

Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder (NCT05999240) is a Phase 2 interventional studying Autism Spectrum Disorder, sponsored by New York State Psychiatric Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This Phase 2 study examines the safety, tolerability, and preliminary efficacy of pimavanserin in individuals with Autism Spectrum Disorder. Male or female participants aged 12 to 40 years of age will be randomized to receive single doses of either placebo or pimavanserin in this randomized, placebo-controlled, cross-over designed study, followed by open label extension.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Autism Spectrum Disorder and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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 willing to sign a consent form 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 willing to sign a consent form 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Pimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID]

Participants will be randomized to take a single dose of either pimavanserin 34 mg or placebo at Visit 2.

DRUG

Placebo

Placebo for Pimavanserin Tartrate 34 Mg ORAL CAPSILE \[NUPLAZID\]

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Kansas, Center for Research
Lawrence, Kansas, United States
Center for Autism and the Developing Brain
White Plains, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05999240), the sponsor (New York State Psychiatric Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05999240 clinical trial studying?

This Phase 2 study examines the safety, tolerability, and preliminary efficacy of pimavanserin in individuals with Autism Spectrum Disorder. Male or female participants aged 12 to 40 years of age will be randomized to receive single doses of either placebo or pimavanserin in this randomized, placebo-controlled, cross-over designed study, followed by open label extension. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05999240?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05999240?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05999240. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05999240. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.