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Pediatric Open-Label Extension Study

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ClinicalTrials.gov Identifier: NCT01914393
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Sunovion

Brief 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

Condition or disease Intervention/treatment Phase
Schizophrenia Autism Bipolar Depression Drug: Lurasidone 20, 40, 60, 80 mg, flexibly dosed Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 702 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects
Actual Study Start Date : September 30, 2013
Actual Primary Completion Date : October 17, 2018
Actual Study Completion Date : October 17, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Lurasidone

Arm Intervention/treatment
Experimental: Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Lurasidone 20, 40, 60, 80 mg, flexibly dosed, once daily
Drug: Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Lurasidone 20, 40, 60, 80 mg once daily, flexibly dosed
Other Name: Latuda




Primary Outcome Measures :
  1. Number of treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation and serious AEs (SAEs) [ Time Frame: 104 Weeks ]
  2. Change in Laboratory tests [ Time Frame: 104 Weeks ]
  3. Change in Movement disorders as assessed by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and the Simpson-Angus Scale (SAS) [ Time Frame: 104 Weeks ]
  4. Change in Tanner staging, and menstrual cyclicity (female subjects) [ Time Frame: 104 Weeks ]
  5. Change in Vital Signs [ Time Frame: 104 Weeks ]
    Vital signs following 5 minutes of seated rest will consist of supine systolic and diastolic blood pressures, respiration rate, heart rate, and oral body temperature.

  6. Change in Body weight and body mass index [ Time Frame: 104 Weeks ]
  7. Change in Physical Examination [ Time Frame: 104 Weeks ]
    The physical examination includes an assessment of general appearance and a review of systems (dermatologic, head, eyes, ears, nose, mouth/throat/neck, thyroid, lymph nodes, respiratory, cardiovascular, gastrointestinal, extremities, musculoskeletal, neurologic, and psychiatric systems).

  8. Change in height (as measured by stadiometer) [ Time Frame: 104 Weeks ]
  9. Change in electrocardiogram [ Time Frame: 104 Weeks ]
    All ECGs will be obtained in the supine position, after the subject has been resting supine for at least 10 minutes.


Secondary Outcome Measures :
  1. Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 104 Weeks ]
  2. CogState Computerized Cognitive Test Battery [ Time Frame: 104 Weeks ]
  3. Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) [ Time Frame: 104 Weeks ]
  4. Clinical Global Impression-Severity (CGI-S) scale [ Time Frame: 104 Weeks ]
  5. Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 104 Weeks ]
  6. Clinician-rated Children's Global Assessment Scale (CGAS) [ Time Frame: 104 Weeks ]
  7. Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) [ Time Frame: 104 Weeks ]
  8. Aberrant Behavior Checklist (ABC) [ Time Frame: 104 Weeks ]
  9. Children's Yale-Brown Obsessive Compulsive Scales [ Time Frame: 104 Weeks ]
  10. Caregiver Strain Questionnaire (CGSQ) [ Time Frame: 104 Weeks ]
  11. Children's Depression Rating Scale, Revised (CDRS-R) [ Time Frame: 104 Weeks ]
  12. Young Mania Rating Scale (YMRS) [ Time Frame: 104 Weeks ]
  13. Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) [ Time Frame: 104 Weeks ]
  14. Pediatric Anxiety Rating Scale (PARS) [ Time Frame: 104 Weeks ]
  15. Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) [ Time Frame: 104 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914393


  Show 88 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
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Study Director: Lurasidone Medical Director, MD Sunovion

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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01914393     History of Changes
Other Study ID Numbers: D1050302
2013-001694-24 ( EudraCT Number )
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

Keywords provided by Sunovion:
Schizophrenia
Autism
Lurasidone
Latuda

Additional relevant MeSH terms:
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Schizophrenia
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents