Multicenterundersøgelse af Lumateperon til behandling af irritabilitet associeret med autismespektrumforstyrrelse hos pædiatriske patienter
En randomiseret, dobbeltblind, placebokontrolleret, multicenterundersøgelse til vurdering af Lumateperons effektivitet og sikkerhed ved behandling af irritabilitet forbundet med autismespektrumforstyrrelse hos pædiatriske patienter i alderen 5 til 17 år
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
The study will be conducted in 3 phases:
- Screening Period (up to 14 days) during which patient eligibility will be assessed.
- Double-blind Treatment Period (DBTP) (6 weeks) during which all patients will be randomized in a 1:1:1 ratio to receive either lumateperone high dose, lumateperone low dose, or placebo as a once daily dose.
- Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up (SFU) visit approximately 1 week after the last dose of study drug.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Alabama
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Dothan, Alabama, Forenede Stater, 36303
- Rekruttering
- Harmonex Neuroscience Research
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Arizona
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Phoenix, Arizona, Forenede Stater, 85006
- Rekruttering
- Southwest Autism Research and Resource Center
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California
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Anaheim, California, Forenede Stater, 92805
- Rekruttering
- Advanced Research Center Inc
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Oceanside, California, Forenede Stater, 92056
- Rekruttering
- Excell Research Inc
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Redlands, California, Forenede Stater, 92373
- Rekruttering
- Inland Psychiatric Medical Group Inc
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Upland, California, Forenede Stater, 91786
- Afsluttet
- Buena Park Research
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West Covina, California, Forenede Stater, 91790
- Rekruttering
- Next Level Clinical Trials, LLC
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80910
- Afsluttet
- MCB Clinical Research Centers LLC
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Florida
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Fort Myers, Florida, Forenede Stater, 33901
- Suspenderet
- Royal Palm Clinical Research
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Gainesville, Florida, Forenede Stater, 32607
- Rekruttering
- Sarkis Clinical Trials
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Jacksonville, Florida, Forenede Stater, 32258
- Rekruttering
- Green Leaf Clinical Trials
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Miami, Florida, Forenede Stater, 33176
- Rekruttering
- Anchor Medical Research LLC
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Miami, Florida, Forenede Stater, 33176
- Rekruttering
- Links Clinical Trials
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Miami, Florida, Forenede Stater, 33125
- Rekruttering
- Columbus Clinical Services LLC
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Miami, Florida, Forenede Stater, 33175
- Rekruttering
- Diverse Clinical Research LLC
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Miami, Florida, Forenede Stater, 33166
- Rekruttering
- South Florida Research Phase I-IV
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Miami Gardens, Florida, Forenede Stater, 33169
- Rekruttering
- The Angel Medical Research Corporation
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West Palm Beach, Florida, Forenede Stater, 33407
- Rekruttering
- Health Synergy Clinical Research
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Georgia
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Savannah, Georgia, Forenede Stater, 31405
- Rekruttering
- CenExeli Research LLC
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Illinois
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Elgin, Illinois, Forenede Stater, 60123
- Rekruttering
- Revive Research Institute
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Springfield, Illinois, Forenede Stater, 62701
- Suspenderet
- Southern Illinois University School of Medicine
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Afsluttet
- Massachusetts General Hospital
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Worcester, Massachusetts, Forenede Stater, 01655
- Rekruttering
- UMass Memorial Healthcare
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Missouri
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Saint Charles, Missouri, Forenede Stater, 63304
- Rekruttering
- Midwest Research Group
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89128
- Rekruttering
- Vector Clinical Trials
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Ohio
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Garfield, Ohio, Forenede Stater, 44125
- Rekruttering
- Charak Center for Health and Wellness
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Westlake, Ohio, Forenede Stater, 44145
- Afsluttet
- Westlake Brain Health
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Access Clinical Trials
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Texas
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Beaumont, Texas, Forenede Stater, 77701
- Rekruttering
- REX Clinical Trials LLC
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Flower Mound, Texas, Forenede Stater, 76028
- Afsluttet
- North Pointe Psychiatry
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Houston, Texas, Forenede Stater, 77089
- Rekruttering
- Kaleidoscope Clinical Research
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Plano, Texas, Forenede Stater, 75093
- Rekruttering
- AIM Trials
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Richmond, Texas, Forenede Stater, 77407
- Rekruttering
- Perceptive Pharma Research
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Virginia
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Petersburg, Virginia, Forenede Stater, 23805
- Rekruttering
- Clinical Research Partners, LLC
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Washington
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Bellevue, Washington, Forenede Stater, 98007
- Rekruttering
- Northwest Clinical Research Center
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Belgrade, Serbien, 11000
- Rekruttering
- Institute of Mental Health Serbia
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Belgrade, Serbien, 11000
- Rekruttering
- Institute of Mental Health Serbia 1
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Belgrade, Serbien, 11070
- Rekruttering
- Clinic of Neurology and Psychiatry for Children and Youth
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Niš, Serbien, 18000
- Rekruttering
- University Clinical Center NIS
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
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All patients must have a legally authorized representative 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.
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Able to provide consent as follows:
- The patient's LAR must provide written, informed consent.
- When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
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Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
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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);
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ABC-I subscale score of >18 at Screening and Baseline;
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CGI-S score > 4 with respect to irritability associated with ASD at Screening and Baseline.
Exclusion Criteria:
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Has a primary psychiatric diagnosis other than ASD. Exceptions include:
- 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.
- Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).
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History or current diagnosis of Rett syndrome or Fragile X syndrome;
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In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or
- At Screening, 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, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
- At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
- The patient is considered to be an imminent danger to themselves or others.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: Placebo
Placebo |
Matching Placebo administered orally once daily |
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Eksperimentel: Lumateperone high dose
Lumateperone 42 mg for patients ages 13-17 years old |
Lumateperone administered orally once daily |
|
Eksperimentel: Lumateperone low dose
Lumateperone 21 mg for patients ages 13-17 years old |
Lumateperone administered orally once daily |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Aberrant Behavior Checklist - Irritability (ABC-I)
Tidsramme: Week 6
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The ABC-I subscale contains 15 items which rate symptoms on a scale ranging from 0 (not at all a problem) to 3 (severe). |
Week 6
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical Global Impression-Severity (CGI-S)
Tidsramme: Week 6
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The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). |
Week 6
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ITI-007-601
- ITI-007-601 (Anden identifikator: Janssen Research & Development, LLC)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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