Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder
ConditionAutism Spectrum Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-40
SponsorNew York State Psychiatric Institute
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Pimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID]
DrugParticipants will be randomized to take a single dose of either pimavanserin 34 mg or placebo at Visit 2.
Placebo
DrugPlacebo for Pimavanserin Tartrate 34 Mg ORAL CAPSILE \[NUPLAZID\]
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Pimavanserin tartrateExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the impact of a single dose of pimavanserin 34 mg versus placebo
Assessed using cognitive neuroscience task, comparison between pimavanserin and placebo within participants in single-dose cross-over experiment.
Time frame
Post Intervention, 30 days after study completion2
Evaluate pimavanserin for treatment of restricted/repetitive behavior in ASD
Assessed using the Repetitive Behavior Scale - Revised (RBS-R) rated at baseline, 3, and 6 weeks. The RBS-R is a 44-item self-report form used to measure the wide range of repetitive behavior in children, adolescents, and adults with Autism Spectrum disorders. The scale consists of six subscales with questions related to Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Routine Behavior, Sameness Behavior, and Restricted Behavior rated between 0 to 3 on severity of each item.
Time frame
6 weeks of Open-Label treatmentSecondary outcomes
1
Explore the effects of pimavanserin on an electroencephalogram event-related potential (EEG/ERP) reversal learning test
Explore the effects of pimavanserin on an electroencephalogram event-related potential (EEG/ERP) learning task in the cross-over comparison (visits 2 and 3) and again at the end of 6 weeks of open label treatment.
Time frame
Post 6-week treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
New York State Psychiatric Institute
Lead sponsor
University of Kansas Medical Center
Collaborator
Research Foundation for Mental Hygiene, Inc.
Collaborator
Weill Medical College of Cornell University
Collaborator
ACADIA Pharmaceuticals Inc.
Collaborator
Source ClinicalTrials.gov