Back to results

A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension

Primary Purpose

Autism Spectrum Disorder

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Balovaptan

Placebo

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject meets the DSM-5 criteria for ASD for an autism diagnosis and is confirmed using ADOS-2 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:

Pregnancy or breastfeeding, or intention to become pregnant during the study
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

Sites / Locations

Harmonex Neuroscience Research
Southwest Autism Research & Resource Center
Woodland Research Northwest, LLC
University of California , Los Angeles (UCLA); Child, Adolescent Psychiatry
PCSD Feighner Research
University of California at San Francisco
MCB Clinical Research Centers
Yale University / Yale-New Haven Hospital
Sarkis Clinical Trials
APG- Advanced Psychiatric Group
IMIC Inc.
Rush University Medical Center
Uni of Chicago; Centre For Advanced Medicine
Lake Charles Clinical Trials, LLC
The Johns Hopkins Hospital
Massachusetts General Hospital
University of Minnesota Medical Center-Fairview
Millennium Psychiatric Associates, LLC
Hapworth Research Inc.
Center for Autism and the Developing Brain
Nathan S. Kline Institute for Psychiatric Research
Richmond Behavioral Associates
University Hospitals
Ohio State University
Cutting Edge Research Group
UPMC Western Psychiatric Institute and Clinic
Vanderbilt University Medical Center; Department of Psychiatry
BioBehavioral Research of Austin, PC
Red Oak Psychiatry Associates, PA
Aspen Clinical Research
Northwest Clinical Research Center
Seattle Children's Hospital
Okanagan Clinical Trials
Holland Bloorview Kids Rehabilitation Hospital; Autism Research Centre
University of Western Ontario
McGill University Health Centre - Glen Site
Hopital Charles Perrens; Centre de Ressources Autisme Aquitaine
Hospices Civils de Lyon; Centre d'Investigation Clinique Pédiatrique
Centre hospitalier du Rouvray; CRAHN Centre de Ressources Autisme Haute-Normandie
ASST di Pavia; Dip. di Scienze del Sistema Nervoso e del Comportamento
AUSL di Piacenza; Psichiatria di Collegamento
ASL TO2; Centro Pilota Regione Piemonte - Dip. Salute Mentale
A.O.U. Policlinico - V. Emanuele - P.O. Gaspare Rodolico; Dip. Terapia integrata disturbi resistenti
Hospital Mutua de Terrassa; Departamento de Psiquiatria
Hospital Universitari Vall d'Hebron; Sevicio de Psiquiatría
Hospital General Universitario Gregorio Marañon; Servicio de Psiquiatria del niño y del adolescente
Hospital Universitario Rio Hortega; Departamento de Psiquiatria
Western General Hospital; Wellcome Trust CRF
Queen Elizabeth University Hospital; Clinical Research Facility
Kings College Hospital; Kings Clinical Research Facility
RE:Cognition Health; RE:Cognition Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Balovaptan

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline at Week 24 on the Vineland Adaptive Behavior Scales (Vineland-II) Two-domain Composite (2DC) Score.

Vineland™-II Adaptive Behavior Scales 2-Domain Composite (2DC) Score is defined as mean of the Communication domain standard score & Socialization domain standard score. If any of the 2 individual domain standard scores is missing 2DC score is not computed. Vineland™-II is an instrument that measures communication, daily living skills, socialization, motor skills and maladaptive behavior of individuals with developmental disabilities. Survey Interview Form will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning.

Secondary Outcome Measures

Change From Baseline at Week 12 on the Vineland-II 2DC Score

Change From Baseline at Weeks 12 and 24 in the Pediatric Quality of Life (PedsQL) Inventory Generic Core Scales, Version 4.0, on Summary and Total Scores

The Pediatric Quality of Life Inventory PedsQL™4.0 Generic Core Scale assessment consists of a 23 item questionnaire encompassing 4 core scale domains: Physical Functioning (8 items); Emotional Functioning (5 items); Social Functioning (5 items); and School Functioning (5 items). Items are scored on a 5 point Likert-type response scale (0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; and 4=almost always a problem). Once scored, items will be reverse scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0), so that higher scores indicate better health-related quality of life.

Change From Baseline at Weeks 12 and 24 in the Vineland-II Adaptive Behavior Composite Standard Score

The Vineland-II is an instrument that measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the Vineland-II Adaptive Behavior Composite score. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning. Only descriptive statistics presented instead of the planned estimated due to the early discontinuation of the study due to futility.

Change From Baseline at Week 12 and 24 on the Vineland-II Socialization Domain Standard Score

The Vineland-II is an instrument that measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the Vineland-II Adaptive Behavior Composite score. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning. Only descriptive statistics presented instead of the planned estimand due to the early discontinuation of the study due to futility.

Change From Baseline at Weeks 12 and 24 on the Vineland-II Communication Domain Standard Score

Change From Baseline at Weeks 12 and 24 on the Vineland-II Daily Living Skills Domain Standard Score

Change From Baseline in Severity of Clinical Impressions as Measured by Clinical Global Impression-Severity (CGI-S)

The CGI-S reflects the rater's impression of the subject's current autism severity on a 7-point scale ranging from no symptoms (1) to very severe symptoms (7). Changes in CGI-S score were calculated as increase or decrease in absolute CGI-S scores between Baseline and Weeks 12 and 24. Percentage of participants reported for each change in score from baseline.

Improvements in Clinical Impressions, as Measured by Clinical Global Impression-Improvement (CGI-I)

This is a 7-point Likert scale that assesses improvement of the patient's condition. Scores range from the worst score of 7 (Very much worse) to the best score of 1 (Very much improved). Lower scores are better on this scale, and indicate greater improvement. Percentage of participants reported for each score.

Change From Baseline at Weeks 12 and 24 in the Hamilton Anxiety Rating Scale (HAM-A) Total and Domain Scores

The HAM-A is a 14-item, rater administered interview, assessing the severity of anxiety symptoms during the past 7 days. Seven items assess psychic anxiety and seven assess somatic anxiety. Each item utilizes a 5-point symptom severity response scale, ranging from none (0) to very severe (4). A total score is calculated that ranges from 0 to 56; higher scores are indicative of more severe anxiety.

Proportion of Subjects With a >=6-point Improvement in Vineland-II 2DC Score

The Vineland-II is an instrument that measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the Vineland-II Adaptive Behavior Composite score. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning All participants who have an improvement of at least 6 points are included in the >=6 score threshold

Percentage of Participants With Adverse Events

According to the ICH guideline for Good Clinical Practice, an adverse event is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The Blinded Treatment Period continued for 24 weeks, Open Label Extension (OLE) Treatment Period continued up to 2 years. The study was pre-maturely terminated, therefore did not reach the planned end date.

Full Information

NCT ID

NCT03504917

First Posted

April 12, 2018

Last Updated

October 26, 2021

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT03504917

Brief Title

A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension

Official Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Terminated

Why Stopped

A futility analysis assessed that the study is highly unlikely to meet the pre-defined primary objective of the study. No new safety concerns were identified.

Study Start Date

August 8, 2018 (Actual)

Primary Completion Date

March 4, 2020 (Actual)

Study Completion Date

July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults (18 years and older) with autism spectrum disorder (ASD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

322 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Balovaptan

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Balovaptan

Intervention Description

Participants will receive 10 mg of oral administration balovaptan once a day (QD).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will receive matching placebo.

Primary Outcome Measure Information:

Title

Change From Baseline at Week 24 on the Vineland Adaptive Behavior Scales (Vineland-II) Two-domain Composite (2DC) Score.

Description

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

Change From Baseline at Week 12 on the Vineland-II 2DC Score

Description

Time Frame

Week 12

Title

Change From Baseline at Weeks 12 and 24 in the Pediatric Quality of Life (PedsQL) Inventory Generic Core Scales, Version 4.0, on Summary and Total Scores

Description

Time Frame

Weeks 12 and 24

Title

Change From Baseline at Weeks 12 and 24 in the Vineland-II Adaptive Behavior Composite Standard Score

Description

Time Frame

Weeks 12 and 24

Title

Change From Baseline at Week 12 and 24 on the Vineland-II Socialization Domain Standard Score

Description

The Vineland-II is an instrument that measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the Vineland-II Adaptive Behavior Composite score. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning. Only descriptive statistics presented instead of the planned estimand due to the early discontinuation of the study due to futility.

Time Frame

Baseline, Weeks 12 and 24

Title

Change From Baseline at Weeks 12 and 24 on the Vineland-II Communication Domain Standard Score

Description

Time Frame

Weeks 12 and 24

Title

Change From Baseline at Weeks 12 and 24 on the Vineland-II Daily Living Skills Domain Standard Score

Description

Time Frame

Weeks 12 and 24

Title

Change From Baseline in Severity of Clinical Impressions as Measured by Clinical Global Impression-Severity (CGI-S)

Description

Time Frame

Weeks 12 and 24

Title

Improvements in Clinical Impressions, as Measured by Clinical Global Impression-Improvement (CGI-I)

Description

Time Frame

Weeks 12 and 24

Title

Change From Baseline at Weeks 12 and 24 in the Hamilton Anxiety Rating Scale (HAM-A) Total and Domain Scores

Description

Time Frame

Weeks 12 and 24

Title

Proportion of Subjects With a >=6-point Improvement in Vineland-II 2DC Score

Description

The Vineland-II is an instrument that measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the Vineland-II Adaptive Behavior Composite score. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning All participants who have an improvement of at least 6 points are included in the >=6 score threshold

Time Frame

Weeks 12 and 24

Title

Percentage of Participants With Adverse Events

Description

Time Frame

Week 24 and Up to Approximately 2 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject meets the DSM-5 criteria for ASD for an autism diagnosis and is confirmed using ADOS-2 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: Pregnancy or breastfeeding, or intention to become pregnant during the study 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Harmonex Neuroscience Research

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36303

Country

United States

Facility Name

Southwest Autism Research & Resource Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

Woodland Research Northwest, LLC

City

Rogers

State/Province

Arkansas

ZIP/Postal Code

72758

Country

United States

Facility Name

University of California , Los Angeles (UCLA); Child, Adolescent Psychiatry

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

PCSD Feighner Research

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

University of California at San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

MCB Clinical Research Centers

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80910

Country

United States

Facility Name

Yale University / Yale-New Haven Hospital

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519-1124

Country

United States

Facility Name

Sarkis Clinical Trials

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

APG- Advanced Psychiatric Group

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

IMIC Inc.

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157

Country

United States

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Uni of Chicago; Centre For Advanced Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Lake Charles Clinical Trials, LLC

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

The Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

University of Minnesota Medical Center-Fairview

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55414

Country

United States

Facility Name

Millennium Psychiatric Associates, LLC

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63132

Country

United States

Facility Name

Hapworth Research Inc.

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

Facility Name

Center for Autism and the Developing Brain

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Nathan S. Kline Institute for Psychiatric Research

City

Orangeburg

State/Province

New York

ZIP/Postal Code

10962

Country

United States

Facility Name

Richmond Behavioral Associates

City

Staten Island

State/Province

New York

ZIP/Postal Code

10312

Country

United States

Facility Name

University Hospitals

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Cutting Edge Research Group

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

Facility Name

UPMC Western Psychiatric Institute and Clinic

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15203

Country

United States

Facility Name

Vanderbilt University Medical Center; Department of Psychiatry

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

Facility Name

BioBehavioral Research of Austin, PC

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

Facility Name

Red Oak Psychiatry Associates, PA

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Aspen Clinical Research

City

Orem

State/Province

Utah

ZIP/Postal Code

84058

Country

United States

Facility Name

Northwest Clinical Research Center

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98007

Country

United States

Facility Name

Seattle Children's Hospital

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Okanagan Clinical Trials

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 1Z9

Country

Canada

Facility Name

Holland Bloorview Kids Rehabilitation Hospital; Autism Research Centre

City

East York

State/Province

Ontario

ZIP/Postal Code

M4G 1R8

Country

Canada

Facility Name

University of Western Ontario

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4G5

Country

Canada

Facility Name

McGill University Health Centre - Glen Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Hopital Charles Perrens; Centre de Ressources Autisme Aquitaine

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Hospices Civils de Lyon; Centre d'Investigation Clinique Pédiatrique

City

LYON Cedex

ZIP/Postal Code

69003

Country

France

Facility Name

Centre hospitalier du Rouvray; CRAHN Centre de Ressources Autisme Haute-Normandie

City

Sotteville Les Rouen

ZIP/Postal Code

76300

Country

France

Facility Name

ASST di Pavia; Dip. di Scienze del Sistema Nervoso e del Comportamento

City

Pavia

State/Province

Lombardia

ZIP/Postal Code

27100

Country

Italy

Facility Name

AUSL di Piacenza; Psichiatria di Collegamento

City

Piacenza

State/Province

Lombardia

ZIP/Postal Code

29121

Country

Italy

Facility Name

ASL TO2; Centro Pilota Regione Piemonte - Dip. Salute Mentale

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10138

Country

Italy

Facility Name

A.O.U. Policlinico - V. Emanuele - P.O. Gaspare Rodolico; Dip. Terapia integrata disturbi resistenti

City

Catania

State/Province

Sicilia

ZIP/Postal Code

95123

Country

Italy

Facility Name

Hospital Mutua de Terrassa; Departamento de Psiquiatria

City

Terrassa

State/Province

Barcelona

ZIP/Postal Code

08221

Country

Spain

Facility Name

Hospital Universitari Vall d'Hebron; Sevicio de Psiquiatría

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital General Universitario Gregorio Marañon; Servicio de Psiquiatria del niño y del adolescente

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Hospital Universitario Rio Hortega; Departamento de Psiquiatria

City

Valladolid

ZIP/Postal Code

47012

Country

Spain

Facility Name

Western General Hospital; Wellcome Trust CRF

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

Queen Elizabeth University Hospital; Clinical Research Facility

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Kings College Hospital; Kings Clinical Research Facility

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

RE:Cognition Health; RE:Cognition Health

City

London

ZIP/Postal Code

W1G 9JF

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35151410

Citation

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.

Results Reference

derived

Learn more about this trial

A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension

We'll reach out to this number within 24 hrs