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New treatment option for Autism Spectrum Disorder
Official title Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT05999240
What this study is testing
What is Pimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID]?
Pimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID] is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for autism spectrum disorder.
Also referred to as Nuzplazid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 40
You may be able to join if
- 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...
- Participant must have a diagnosis of Autism Spectrum Disorder, according to DSM-5 criteria, made by a licensed study psychiatrist or psychologist and...
- Participant must have a Clinical Global Impression of Severity for Repetitive Behavior of 4 or greater, as rated by the study psychiatrist or...
- 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.
You likely can't join if
- 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...
- Participant has a history of any severe or unstable psychiatric condition (e.g., schizophrenia or other psychotic disorder, bipolar disorder, major...
- Participant has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 3 or...
- Participant has met DSM-5 criteria for a substance abuse disorder within the last 6 months prior to Screening, except for disorders related to...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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)...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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) \ 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...
- 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...
- 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...
- 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...
- 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 \ 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lawrence, Kansas, United States
- White Plains, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lawrence, Kansas, United States; White Plains, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.