Health Condition 1: F840- Autistic disorder
Conditions
Interventions
Intervention1: Lumateperone: Dose: high-dose lumateperone (42 mg), low-dose lumateperone (21 mg)
Route: Oral
Duration: 6 Weeks
Frequency: Once daily in the
evening
Control Intervention1: Matching Pl
Sponsors
Intra-Cellular Therapies, Inc.
IQVIA RDS INDIA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible to participate in the study, patients must meet the following inclusion criteria: 1. All patients must have an LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient’s condition, and accompany the patient to study visits. NOTE: Patients who turn 18 years of age during participation in this study will be allowed to continue study participation for the duration of this trial. 2. Able to provide consent as follows: a. The patient’s LAR must provide written, informed consent. If a patient turns the age of majority (18 years of age in most jurisdictions) during study participation, they should sign the informed consent at the visit following their birthday if developmentally appropriate. b. When developmentally appropriate based on Investigator judgment, the patient should provide written assent. 3. Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment. NOTE: Patients aged 5 to 12 years will be eligible for enrollment when PK data supporting dose selection for this age group are available. The protocol will be amended in the future to allow enrollment of these younger patients. 4. Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL) 5. ABC-I subscale score of more than 18 at Screening and Baseline. 6. CGI-S score more than 4 with respect to irritability associated with ASD at Screening and Baseline. 7. Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study. Patients who require inpatient washout will be evaluated by the Investigator for suitability to transition to outpatient status at the end of the Screening Period. 8. Female patients of childbearing potential must have negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline (Visit 2) and a. Agree to use highly effective methods of birth control (including but not limited to combined and progesterone-only hormonal contraception associated with inhibition of ovulation, intrauterine device or hormone-releasing system, vasectomized partner, bilateral tubal occlusion) from the time informed consent (and assent if developmentally appropriate) is provided through the end of the SFU period. b. Sexual abstinence may be an acceptable form of birth control based on the Investigators judgment and familiarity with the patients preferred and usual lifestyle. NOTE: Females of non-childbearing potential (defined as either not achieved menarche or permanently sterilized) are exempt from the birth control requirement. If a female patient reaches menarche during the study, the Investigator should have an age-appropriate discussion with the patient and LAR to determine if contraceptive requirements (as noted above) are met. It is the responsibility of Investigator to monitor and reassess the contraception requirement during the course of the study. b. Sexual abstinence may be an acceptable form of birth control based on the Investigators judgment and familiarity with the patients preferred and usual lifestyle <b
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria will not be eligible to participate in the study. Psychiatric and Neurological Exclusion Criteria: 1. Has a primary psychiatric diagnosis other than ASD. Exceptions include: a. attention deficit hyperactivity disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records. b. Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded). 2. History or current diagnosis of Rett syndrome or Fragile X syndrome 3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or a. At Screening (Visit 1), the patient scores “yes” on Suicidal Ideation Items 3, 4, or 5 of the Columbia–Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline (Visit 2), the patient scores “yes” on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit b. At Screening (Visit 1), the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or c. The patient is considered to be an imminent danger to him per herself or others. Treatment-related Exclusion Criteria: 4. Electroconvulsive therapy (ECT), vagal nerve stimulation, repetitive trans-cranial magnetic stimulation, or any other neuromodulation therapies for any central nervous system and psychiatry indications within 6 months prior to Screening 5. Likely allergy or sensitivity to lumateperone or its excipients, based on known allergies or hypersensitivities to drugs with shared pharmacology which may be suggestive of an increased potential for an adverse reaction to lumateperone; 6. Use of any strong or moderate cytochrome P450 3A4 inhibitor or any cytochrome P450 3A4 inducer as described in Table 7-3–Restricted and Prohibited Medications; 7. Use of monoamine oxidase inhibitors within 14 days prior to Baseline (Visit 2); 8. Unable or unwilling to discontinue other antipsychotics prior to randomization (Baseline per Visit 2) as described in Table 7-3–Restricted and Prohibited Medications. 9. Use of benzodiazepines and other sleep aids (see Table 7-2–Guidance for Concomitant Medications for permitted treatments for insomnia). 10. The patient has a positive test for alcohol or drugs of abuse (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opioids opiates) at Screening (Visit 1). Exceptions may include appropriate prescription treatments (eg, opioids, benzodiazepines) if the use is not chronic and is able to be discontinued restricted as per the Investigator with the concurrence of the Sponsor or designee. A repeat drug test is allowed with the approval of the Sponsor or designee. 11. Use of a depot per long-acting injectable antipsychotic medication within 2 treatment cycles prior to Screening (Visit 1) 12. Is unable to be safely discontinued from prohibited medications (in the opinion of the Investigator). 13. Use of dietary supplements and medical foods unless approved by the Sponsor or designee. Daily mu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy objective of this study is to evaluate the efficacy of high and low doses of lumateperone vs placebo for the treatment of irritability associated with ASD in pediatric patients aged 5 to 17 years as measured by the change from baseline to end of Week 6 in the ABC Irritability (ABC-I) subscale scoreTimepoint: Change from baseline to the end of Week 6 in the ABC-I subscale score | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary efficacy objective of this study is to evaluate the efficacy of high and low doses of lumateperone vs placebo for the treatment of irritability associated with ASD in pediatric patients aged 5 to 17 years as measured by the change from baseline to end of Week 6 in the Clinical Global Impression-Severity (CGI-S) score with respect to irritabilityTimepoint: Change from baseline to the end of Week 6 in the CGI-S score | — |
Countries
India, Mexico, Serbia, United States of America
Contacts
Public ContactShweta Pradhan
IQVIA RDS (India) Private Limited
Outcome results
None listed