Pediatric Open-Label Extension Study

Last updated: December 18, 2019
Sponsor: Sunovion
Overall Status: Completed

Phase

3

Condition

Autism

Bipolar Disorder

Tourette's Syndrome

Treatment

N/A

Clinical Study ID

NCT01914393
D1050302
2013-001694-24
  • Ages 6-17
  • All Genders

Study 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

Inclusion Criteria:

  • Written informed consent from parent(s) or legal guardian(s) with sufficientintellectual capacity to understand the study and support subjects' participation inthe study procedures must be obtained for subjects who are not emancipated. Inaccordance with Institutional Review Board (IRB) or Independent Ethics Committee (IEC)requirements, the subject will complete an informed assent when developmentallyappropriate, to participate in the study before conduct of any study-specificprocedures.

  • 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 lurasidonetreatment, and is able to comply with the protocol.

  • A reliable informant (eg, parent, legal guardian, or caregiver) must be available toaccompany the subject at each visit. For subjects entering from Study D1050325, thereliable caregiver must also oversee the administration of the study drug throughoutthe 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 remainabstinent from signing informed consent to at least 7 days after the last dose ofstudy drug has been taken; -OR-

  • are sexually active and willing to use a medically effective method of birthcontrol (eg, male using condom and female using condom, diaphragm, contraceptivesponge, spermicide, contraceptive pill, or intrauterine device) from signinginformed consent to at least 7 days after the last dose of study drug has beentaken.

  • Males must be willing to remain sexually abstinent (consistent with lifestyle) or usean effective method of birth control (eg, male using condom and female using condom,diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterinedevice) from signing informed consent to at least 7 days after the last dose of studydrug has been taken.

Exclusion

Exclusion Criteria:

  • Subject is considered by the investigator to be at imminent risk of suicide.

  • Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardivedyskinesia, or any other moderate or severe movement disorder. Severity to bedetermined by the investigator.

Study Design

Total Participants: 702
Study Start date:
September 30, 2013
Estimated Completion Date:
October 17, 2018

Connect with a study center

  • MHC - Ruse, EOOD

    Ruse, 7003
    Bulgaria

    Site Not Available

  • UMHAT "Alexandrovska" EAD

    Sofia, 1431
    Bulgaria

    Site Not Available

  • MHAT-Targovishte, AD

    Targovishte, 7700
    Bulgaria

    Site Not Available

  • DCC "Mladost M" - Varna, OOD

    Varna, 9020
    Bulgaria

    Site Not Available

  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA

    Barranquilla,
    Colombia

    Site Not Available

  • E.S.E. Hospital Mental de Antioquia

    Bello, 0000
    Colombia

    Site Not Available

  • Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

    Bogota, 00000
    Colombia

    Site Not Available

  • CHU Nantes - Hôpital Mère-Enfant

    Nantes Cedex 1, 44093
    France

    Site Not Available

  • Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

    Budapest, 1021
    Hungary

    Site Not Available

  • Bekes Megyei Pandy Kalman Korhaz

    Gyula, 57--
    Hungary

    Site Not Available

  • Seoul National University Hospital

    Seoul, Gyeonggi-do 110774
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital

    Gwangju, 501-757
    Korea, Republic of

    Site Not Available

  • Inha University Hospital

    Incheon, 400-711
    Korea, Republic of

    Site Not Available

  • Chonbuk National University Hospital

    Jeonju, 561-712
    Korea, Republic of

    Site Not Available

  • Chonbuk National University Hospital

    Jeonju-si, 561-712
    Korea, Republic of

    Site Not Available

  • University Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.

    Culiacan, Sinaloa 80020
    Mexico

    Site Not Available

  • Dr. Jessica Rosas Escobar

    Durango, 34000
    Mexico

    Site Not Available

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

    Durango, 34000
    Mexico

    Site Not Available

  • Instituto Nacional de Pediatria

    Mexico, 04530
    Mexico

    Site Not Available

  • Accelerium S. de R.L. de C.V.

    Monterrey, 64000
    Mexico

    Site Not Available

  • Instituto de Informacion de Investigacion en Salud Mental

    Monterrey, 64710
    Mexico

    Site Not Available

  • Av Modesto Arreola #917 Ote. Col Centro

    Nuevo León, 64000
    Mexico

    Site Not Available

  • Alexian Brothers Health and Wellness Center

    Davao City, 8000
    Philippines

    Site Not Available

  • West Visayas State University Medical Center

    Iloilo, 5000
    Philippines

    Site Not Available

  • West Visayas State University Medical Center

    Iloilo City, 5000
    Philippines

    Site Not Available

  • National Center for Mental Health

    Mandaluyong City, 1553
    Philippines

    Site Not Available

  • Veterans Memorial Medical Center

    Quezon City, 1101
    Philippines

    Site Not Available

  • NZOZ Poradnia Zdrowia Psychicznego

    Kobierzyce, 55-040
    Poland

    Site Not Available

  • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddzial Kliniczmy VI Psychiatrii Mlodziezy

    Toruń, 87-100
    Poland

    Site Not Available

  • Centro de Investigacion Clinica Psiquiatrica

    Caguas, 00725
    Puerto Rico

    Site Not Available

  • INSPIRA Clinical Research

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia

    Bucuresti, 041914
    Romania

    Site Not Available

  • Spitalul Clinic de Psihiatrie Socola

    Iasi, 700282
    Romania

    Site Not Available

  • Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara

    Timisoara, 300239
    Romania

    Site Not Available

  • Sverdiovsk Regional Clinical Psychiatric Hospital

    Ekaterinburg, 62003
    Russian Federation

    Site Not Available

  • GUZ Lipetsk Regional psychoneurological Hospital #1

    Lipetsk, 399313
    Russian Federation

    Site Not Available

  • GUZ Lipetsk Regional psychoneurological Hospital #1

    Lipetsk region, 399313
    Russian Federation

    Site Not Available

  • Closed corporation "Scientific Center of Personalized Psychiatry"

    Moscow, 119180
    Russian Federation

    Site Not Available

  • Scientific Center of Personalized Psychiatry

    Moscow, 119180
    Russian Federation

    Site Not Available

  • State Healthcare Institution of Nizhniy Novgordo region "Clinical Psychiatric Hospital #1 of City of Nizhniy Novgorod"

    Nizhny Novgorod, 603155
    Russian Federation

    Site Not Available

  • Bekhterev Institute

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Center of Recovery Treatment "Pediatric Psychiatry" named after S.S. Mnukhin

    Saint Petersburg, 197022
    Russian Federation

    Site Not Available

  • SHI "City Psychoneurological dispensary #7 (with Hospital)"

    Saint Petersburg, 190005
    Russian Federation

    Site Not Available

  • Regional Clinical Mental Hospital of Saint Sofiya

    Saratow, 410060
    Russian Federation

    Site Not Available

  • FSBSI "Scientific Research Institute of Mental Health"

    Tomsk, 634014
    Russian Federation

    Site Not Available

  • State Healthcare Institution of Yaroslavl Rgion "Yaroslavl Regional clinical Mental Hospital"

    Yaroslavl, 150003
    Russian Federation

    Site Not Available

  • Hospital Marítimo de Torremolinos

    Torremolinos, Málaga 29620
    Spain

    Site Not Available

  • RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU

    Ivano Frankivsk, 76014
    Ukraine

    Site Not Available

  • SI Institute of Children and Adolescents Healthcare of NAMSU

    Kharkiv, 61153
    Ukraine

    Site Not Available

  • SI Institute of Neurology, Psychiatry and Narcology of NAMSU

    Kharkiv, 61068
    Ukraine

    Site Not Available

  • CI Kherson Regional Psychiatric Hospital of Kherson RC

    Kherson,Vil. Stepanivka, 73488
    Ukraine

    Site Not Available

  • TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions

    Kyiv, 04080
    Ukraine

    Site Not Available

  • CI Lviv Regional Clinical Psychiatric Hospital

    Lviv, 79021
    Ukraine

    Site Not Available

  • Odesa Regional Psychoneurological Dispensary, Outpatient Dept.

    Odesa, 65014
    Ukraine

    Site Not Available

  • O.F. Maltcev Poltava RCPsH Children Dept Ukrainian Medical Stomatological Academy

    Poltava, 36006
    Ukraine

    Site Not Available

  • CI Kherson Regional Psychiatric Hospital of Kherson RC

    Stepanivka, 73488
    Ukraine

    Site Not Available

  • Ternopil RCCPH Dept of Psychiatry #9 (adolescent)& #8 (pediatric) Ternopil I.Ya. Gorbachevskyi SMU

    Ternopil, 46020
    Ukraine

    Site Not Available

  • Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI

    Vinnitsia, 21018
    Ukraine

    Site Not Available

  • Harmonex Neuroscience Research

    Dothan, Alabama 36303
    United States

    Site Not Available

  • Southwest Autism Research & Resource Center

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • ProScience Research Group

    Culver City, California 90230
    United States

    Site Not Available

  • Diligent Clinical Trials, Inc

    Downey, California 90241
    United States

    Site Not Available

  • Collaborative Neuroscience Network, LLC

    Garden Grove, California 92845
    United States

    Site Not Available

  • University of California San Francisco Medical Center

    San Francisco, California 94143
    United States

    Site Not Available

  • Neuropsychiatric Research Center of Orange County

    Santa Ana, California 92701
    United States

    Site Not Available

  • Florida Clinical Research Center, LLC

    Bradenton, Florida 34201
    United States

    Site Not Available

  • Sarkis Clinical Trials - Parent

    Gainesville, Florida 32607
    United States

    Site Not Available

  • Palm Springs Research Institute

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Florida Clinical Research Center, LLC

    Maitland, Florida 32751
    United States

    Site Not Available

  • APG Research, LLC

    Orlando, Florida 32803
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida 32801
    United States

    Site Not Available

  • University of South Florida

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • Medical Research Group of Central Florida

    Sanford, Florida 32771
    United States

    Site Not Available

  • University of South Florida Rothman Center of Neuropychiatry

    Tampa, Florida 33613
    United States

    Site Not Available

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Attalla Consultants, LLC

    Smyrna, Georgia 30080
    United States

    Site Not Available

  • Capstone Clinical Research, Inc.

    Libertyville, Illinois 60048
    United States

    Site Not Available

  • Baber Research Group

    Naperville, Illinois 60563
    United States

    Site Not Available

  • Psychiatric Associates

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • University Of Kentucky

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340

    Lake Charles, Louisiana 70601
    United States

    Site Not Available

  • Kennedy Krieger Institute

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Neurobehaviorial Medicine Group, PLLC

    Bloomfied Hills, Michigan 48302
    United States

    Site Not Available

  • Neurobehavioral medicine Group, LLC

    Bloomfield Hills, Michigan 48302
    United States

    Site Not Available

  • St. Charles Psychiatric Associates

    Saint Charles, Missouri 63301
    United States

    Site Not Available

  • St. Charles Psychiatric Associates

    St. Charles, Missouri 63301
    United States

    Site Not Available

  • Center for Psychiatry and Behavioral Medicine, Inc.

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Neptune City, New Jersey 07753
    United States

    Site Not Available

  • Childrens Specialized Hospital

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • North Shore/Long Island Jewish PRIME

    Glen Oaks, New York 11004
    United States

    Site Not Available

  • Dr. Jeanette Cueva

    Mount Kisco, New York 10549
    United States

    Site Not Available

  • Montefiore Medical Center PRIME

    New York, New York 10467
    United States

    Site Not Available

  • Finger Lakes Clinical Research

    Rochester, New York 10618
    United States

    Site Not Available

  • Richmond Behavioral Associates

    Staten Island, New York 10312
    United States

    Site Not Available

  • Chapel Hill Neurology

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University Hospitals Case Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Ohio State University Nisonger Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • Cyn3rgy Research & Development

    Gresham, Oregon 97030
    United States

    Site Not Available

  • Suburban Research Associates

    Media, Pennsylvania 19603
    United States

    Site Not Available

  • Segal Institute for Clinical Research

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • BioBehavioral Research of Austin

    Austin, Texas 78759
    United States

    Site Not Available

  • Pillar Clinical Research, LLC

    Dallas, Texas 75243
    United States

    Site Not Available

  • BioBehavioral Research of Austin

    El Campo, Texas 77437
    United States

    Site Not Available

  • Family Psychiatry of The Woodlands, P.A.

    The Woodlands, Texas 77381
    United States

    Site Not Available

  • Ericksen Research & Development, LLC

    Clinton, Utah 84015
    United States

    Site Not Available

  • Aspen Clinical Research

    Orem, Utah 84058
    United States

    Site Not Available

  • CRI Lifetree

    Salt Lake City, Utah 84106
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Neuroscience, Inc.

    Herndon, Virginia 20170
    United States

    Site Not Available

  • Clinical Research Partners, LLC

    Petersburg, Virginia 23805
    United States

    Site Not Available

  • Carilion Clinic

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • Pacific Institute Of Medical Sciences

    Bothell, Washington 98011
    United States

    Site Not Available

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