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Phase 3 N=702 Treatment

Pediatric Open-Label Extension Study

Schizophrenia · Autism · Bipolar Depression

Enrolled (actual)
702
Serious AEs
11.1%
Results posted
Dec 2019
Primary outcome: Primary: Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) — 214; 106; 252; 572 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Lurasidone 20, 40, 60, 80 mg, flexibly dosed (Drug)
Age
Pediatric · 6+ yrs
Sex
All
Sponsor
Sumitomo Pharma America, Inc.
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs)
214; 106; 252; 572; 28; 13
SECONDARY
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score
76.0; -11.9; -15.6; -18.4
SECONDARY
Change From Baseline in PANSS Positive Subscale Score
17.9; -3.9; -5.1; -5.4
SECONDARY
Change From Baseline in PANSS Negative Subscale Score
20.5; -2.6; -3.4; -4.3
SECONDARY
Change From Baseline in PANSS General Psychopathology Subscale Score
37.5; -5.4; -7.2; -8.7
SECONDARY
Change From Baseline in PANSS Excitability Subscale Score
9.0; -1.3; -1.7; -2.1
SECONDARY
Change From Baseline in the Clinical Global Impression -Severity Score
4.0; -0.87; -1.10; -1.31
SECONDARY
Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score
55.0; 10.94; 14.28; 17.85
SECONDARY
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score
59.52; 8.16; 11.37; 14.75
SECONDARY
Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score
19.0; -2.1; -2.9; -4.2
SECONDARY
Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score
10.3; -0.7; -1.1; -1.1
SECONDARY
Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score
6.1; -0.9; -0.9; -1.1
SECONDARY
Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score
24.1; -3.8; -4.3; -5.6
SECONDARY
Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score
5.2; -0.7; -0.7; -0.5
SECONDARY
Change From Baseline in Clinical Global Impression (CGI) - Severity Score
3.9; -0.43; -0.71; -0.78
SECONDARY
Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS)
10.2; -2.2; -2.3; -3.2
SECONDARY
Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score
7.95; -0.48; -0.60; -0.63
SECONDARY
Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score
39.2; -9.9; -13.4; -16.4
SECONDARY
Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score
3.2; -1.10; -1.36; -1.61
SECONDARY
Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score
61.1; 11.17; 14.67; 18.96
SECONDARY
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score
59.52; 8.16; 11.37; 14.75
SECONDARY
Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score
8.0; -2.7; -3.2; -4.9
SECONDARY
Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score
9.4; -2.2; -2.4; -3.3

Summary

This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326

Eligibility Criteria

Inclusion Criteria

  • Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' participation in the study procedures must be obtained for subjects who are not emancipated. In accordance with Institutional Review Board (IRB) or Independent Ethics Committee (IEC) requirements, the subject will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures.
  • Subject has completed Study D1050301 (Visit 9) OR
  • Subject has completed Study D1050325 (Visit 9) OR
  • Subject has completed Study D1050326 (Visit 8)
  • Subject is judged by the investigator to be appropriate for participation in a 104-week clinical trial in an outpatient setting involving open-label lurasidone treatment, and is able to comply with the protocol.
  • A reliable informant (eg, parent, legal guardian, or caregiver) must be available to accompany the subject at each visit. For subjects entering from Study D1050325, the reliable caregiver must also oversee the administration of the study drug throughout the study
  • Females who participate in this study:
  • are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR-
  • practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 7 days after the last dose of study drug has been taken; -OR-
  • are sexually active and willing to use a medically effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.
  • Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.

Exclusion Criteria

  • Subject is considered by the investigator to be at imminent risk of suicide.
  • Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive dyskinesia, or any other moderate or severe movement disorder. Severity to be determined by the investigator.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01914393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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