A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension
NCT ID: NCT03504917
Last Updated: 2021-10-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
322 participants
INTERVENTIONAL
2018-08-08
2020-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Balovaptan
Balovaptan
Participants will receive 10 mg of oral administration balovaptan once a day (QD).
Placebo
Placebo
Participants will receive matching placebo.
Interventions
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Balovaptan
Participants will receive 10 mg of oral administration balovaptan once a day (QD).
Placebo
Participants will receive matching placebo.
Eligibility Criteria
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Inclusion Criteria
* SRS-2, proxy version, total t-score \>=66 at screening
* A full scale IQ score \>=70 on the WASI®-II
* Subject has an appropriate study partner, in the opinion of the investigator
* For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of \<1% per year during the treatment period and for at least 28 days after the last dose of study drug
* Treatment with permitted medications (at a stable dose for 12 weeks before screening) and behavioral therapy regimens (regimens stable for 6 weeks before screening), with the intent that such treatments remain stable throughout the study and with no expected changes before the Week 24 visit
Exclusion Criteria
* Previous initiation of new or major change in psychosocial intervention within 6 weeks prior to screening
* Unstable or uncontrolled clinically significant affective or psychotic disorders and/or neurologic disorder that may interfere with the assessment of safety or efficacy endpoints
* Substance use disorders during the last 12 months
* Significant risk for suicidal behavior, in the opinion of the investigator
* Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months
* Clinical diagnosis of peripheral neuropathy
* Within the last 2 years, unstable or clinically significant cardiovascular disease
* Uncontrolled hypertension
* Unexplained syncopal episode within the last 12 months
* Confirmed elevation above upper limit of normal of CK-MB, high sensitivity cardiac troponin T, cardiac troponin I, and/or N-terminal pro B-type natriuretic peptide
* Positive serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 or 2
* History of coagulopathies, bleeding disorders, blood dyscrasias, hematological malignancies, myelosuppression (including iatrogenic), or current major bleeding event
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or what would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
* Confirmed clinically significant abnormality in parameters of hematology
* Confirmed clinically significant abnormality in parameters of clinical chemistry, coagulation, or urinalysis
* Medical history of malignancy, if not considered cured
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Harmonex Neuroscience Research
Dothan, Alabama, United States
Southwest Autism Research & Resource Center
Phoenix, Arizona, United States
Woodland Research Northwest, LLC
Rogers, Arkansas, United States
University of California , Los Angeles (UCLA); Child, Adolescent Psychiatry
Los Angeles, California, United States
PCSD Feighner Research
San Diego, California, United States
University of California at San Francisco
San Francisco, California, United States
MCB Clinical Research Centers
Colorado Springs, Colorado, United States
Yale University / Yale-New Haven Hospital
New Haven, Connecticut, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
APG- Advanced Psychiatric Group
Orlando, Florida, United States
IMIC Inc.
Palmetto Bay, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Uni of Chicago; Centre For Advanced Medicine
Chicago, Illinois, United States
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States
Millennium Psychiatric Associates, LLC
St Louis, Missouri, United States
Hapworth Research Inc.
New York, New York, United States
Center for Autism and the Developing Brain
New York, New York, United States
Nathan S. Kline Institute for Psychiatric Research
Orangeburg, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
University Hospitals
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
UPMC Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center; Department of Psychiatry
Nashville, Tennessee, United States
BioBehavioral Research of Austin, PC
Austin, Texas, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
Aspen Clinical Research
Orem, Utah, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Seattle Children's Hospital
Seattle, Washington, United States
Okanagan Clinical Trials
Kelowna, British Columbia, Canada
Holland Bloorview Kids Rehabilitation Hospital; Autism Research Centre
East York, Ontario, Canada
University of Western Ontario
London, Ontario, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
Hopital Charles Perrens; Centre de Ressources Autisme Aquitaine
Bordeaux, , France
Hospices Civils de Lyon; Centre d'Investigation Clinique Pédiatrique
Lyon, , France
Centre hospitalier du Rouvray; CRAHN Centre de Ressources Autisme Haute-Normandie
Sotteville-lès-Rouen, , France
ASST di Pavia; Dip. di Scienze del Sistema Nervoso e del Comportamento
Pavia, Lombardy, Italy
AUSL di Piacenza; Psichiatria di Collegamento
Piacenza, Lombardy, Italy
ASL TO2; Centro Pilota Regione Piemonte - Dip. Salute Mentale
Turin, Piedmont, Italy
A.O.U. Policlinico - V. Emanuele - P.O. Gaspare Rodolico; Dip. Terapia integrata disturbi resistenti
Catania, Sicily, Italy
Hospital Mutua de Terrassa; Departamento de Psiquiatria
Terrassa, Barcelona, Spain
Hospital Universitari Vall d'Hebron; Sevicio de Psiquiatría
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Psiquiatria del niño y del adolescente
Madrid, , Spain
Hospital Universitario Rio Hortega; Departamento de Psiquiatria
Valladolid, , Spain
Western General Hospital; Wellcome Trust CRF
Edinburgh, , United Kingdom
Queen Elizabeth University Hospital; Clinical Research Facility
Glasgow, , United Kingdom
Kings College Hospital; Kings Clinical Research Facility
London, , United Kingdom
RE:Cognition Health; RE:Cognition Health
London, , United Kingdom
Countries
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References
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Jacob S, Veenstra-VanderWeele J, Murphy D, McCracken J, Smith J, Sanders K, Meyenberg C, Wiese T, Deol-Bhullar G, Wandel C, Ashford E, Anagnostou E. Efficacy and safety of balovaptan for socialisation and communication difficulties in autistic adults in North America and Europe: a phase 3, randomised, placebo-controlled trial. Lancet Psychiatry. 2022 Mar;9(3):199-210. doi: 10.1016/S2215-0366(21)00429-6. Epub 2022 Feb 10.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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WN39434
Identifier Type: -
Identifier Source: org_study_id