Multisenterstudie av Lumateperone for behandling av irritabilitet assosiert med autismespektrumforstyrrelse hos pediatriske pasienter
En randomisert, dobbeltblind, placebokontrollert, multisenterstudie for å vurdere effektiviteten og sikkerheten til Lumateperone ved behandling av irritabilitet assosiert med autismespektrumforstyrrelse hos pediatriske pasienter 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).
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Alabama
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Dothan, Alabama, Forente stater, 36303
- Rekruttering
- Harmonex Neuroscience Research
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Arizona
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Phoenix, Arizona, Forente stater, 85006
- Rekruttering
- Southwest Autism Research and Resource Center
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California
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Anaheim, California, Forente stater, 92805
- Rekruttering
- Advanced Research Center Inc
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Oceanside, California, Forente stater, 92056
- Rekruttering
- Excell Research Inc
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Redlands, California, Forente stater, 92373
- Rekruttering
- Inland Psychiatric Medical Group Inc
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Upland, California, Forente stater, 91786
- Fullført
- Buena Park Research
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West Covina, California, Forente stater, 91790
- Rekruttering
- Next Level Clinical Trials, LLC
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Colorado
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Colorado Springs, Colorado, Forente stater, 80910
- Fullført
- MCB Clinical Research Centers LLC
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Florida
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Fort Myers, Florida, Forente stater, 33901
- Suspendert
- Royal Palm Clinical Research
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Gainesville, Florida, Forente stater, 32607
- Rekruttering
- Sarkis Clinical Trials
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Jacksonville, Florida, Forente stater, 32258
- Rekruttering
- Green Leaf Clinical Trials
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Miami, Florida, Forente stater, 33176
- Rekruttering
- Anchor Medical Research LLC
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Miami, Florida, Forente stater, 33176
- Rekruttering
- Links Clinical Trials
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Miami, Florida, Forente stater, 33125
- Rekruttering
- Columbus Clinical Services LLC
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Miami, Florida, Forente stater, 33175
- Rekruttering
- Diverse Clinical Research LLC
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Miami, Florida, Forente stater, 33166
- Rekruttering
- South Florida Research Phase I-IV
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Miami Gardens, Florida, Forente stater, 33169
- Rekruttering
- The Angel Medical Research Corporation
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West Palm Beach, Florida, Forente stater, 33407
- Rekruttering
- Health Synergy Clinical Research
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Georgia
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Savannah, Georgia, Forente stater, 31405
- Rekruttering
- CenExeli Research LLC
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Illinois
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Elgin, Illinois, Forente stater, 60123
- Rekruttering
- Revive Research Institute
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Springfield, Illinois, Forente stater, 62701
- Suspendert
- Southern Illinois University School of Medicine
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Fullført
- Massachusetts General Hospital
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Worcester, Massachusetts, Forente stater, 01655
- Rekruttering
- UMass Memorial Healthcare
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Missouri
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Saint Charles, Missouri, Forente stater, 63304
- Rekruttering
- Midwest Research Group
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Nevada
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Las Vegas, Nevada, Forente stater, 89128
- Rekruttering
- Vector Clinical Trials
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Ohio
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Garfield, Ohio, Forente stater, 44125
- Rekruttering
- Charak Center for Health and Wellness
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Westlake, Ohio, Forente stater, 44145
- Fullført
- Westlake Brain Health
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- Access Clinical Trials
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Texas
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Beaumont, Texas, Forente stater, 77701
- Rekruttering
- REX Clinical Trials LLC
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Flower Mound, Texas, Forente stater, 76028
- Fullført
- North Pointe Psychiatry
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Houston, Texas, Forente stater, 77089
- Rekruttering
- Kaleidoscope Clinical Research
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Plano, Texas, Forente stater, 75093
- Rekruttering
- AIM Trials
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Richmond, Texas, Forente stater, 77407
- Rekruttering
- Perceptive Pharma Research
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Virginia
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Petersburg, Virginia, Forente stater, 23805
- Rekruttering
- Clinical Research Partners, LLC
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Washington
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Bellevue, Washington, Forente stater, 98007
- Rekruttering
- Northwest Clinical Research Center
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Belgrade, Serbia, 11000
- Rekruttering
- Institute of Mental Health Serbia
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Belgrade, Serbia, 11000
- Rekruttering
- Institute of Mental Health Serbia 1
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Belgrade, Serbia, 11070
- Rekruttering
- Clinic of Neurology and Psychiatry for Children and Youth
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Niš, Serbia, 18000
- Rekruttering
- University Clinical Center NIS
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
Placebo |
Matching Placebo administered orally once daily |
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Eksperimentell: Lumateperone high dose
Lumateperone 42 mg for patients ages 13-17 years old |
Lumateperone administered orally once daily |
|
Eksperimentell: Lumateperone low dose
Lumateperone 21 mg for patients ages 13-17 years old |
Lumateperone administered orally once daily |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Aberrant Behavior Checklist - Irritability (ABC-I)
Tidsramme: Week 6
|
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ITI-007-601
- ITI-007-601 (Annen identifikator: Janssen Research & Development, LLC)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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