Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia

2022-502233-25-00 Protocol NBI-98854-ATS3020 Therapeutic confirmatory (Phase III) Ended

End 8 Nov 2023 · Status Ended · 6 EU/EEA countries · 36 sites · Protocol NBI-98854-ATS3020

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ended
Participants planned 400
Countries 6
Sites 36

Schizophrenia

The primary objective for this study is to evaluate the efficacy of adjunctive valbenazine versus placebo on symptoms of schizophrenia in subjects who have inadequate response to antipsychotic treatment

Key facts

Sponsor
Neurocrine Biosciences Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Psychiatry and Psychology [F] - Mental Disorders [F03]
Trial duration
completed 8 Nov 2023
Decision date (initial)
2023-06-15
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Neurocrine Biosciences, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

The primary objective for this study is to evaluate the efficacy of adjunctive valbenazine versus placebo on symptoms of schizophrenia in subjects who have inadequate response to antipsychotic treatment

Secondary objectives 2

  1. Evaluate the efficacy of adjunctive valbenazine versus placebo on illness severity and subject functioning in subjects who have inadequate response to antipsychotic treatment
  2. Evaluate the safety and tolerability of valbenazine as adjunctive treatment in subjects who have inadequate response to antipsychotic treatment

Conditions and MedDRA coding

Schizophrenia

VersionLevelCodeTermSystem organ class
20.0 PT 10039626 Schizophrenia 100000004873

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Medically confirmed diagnosis of schizophrenia
  2. Participant is receiving a stable regimen of background antipsychotic medication.
  3. Plasma levels for at least 1 of the participant's antipsychotic medications must be detectable by an available assay
  4. Participant is an outpatient with stable symptomatology
  5. Participant must have an adult informant (for example, a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse)

Exclusion criteria 3

  1. Has a history of treatment resistant schizophrenia
  2. Have a clinically significant unstable medical condition in the judgement of the investigator or any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit
  3. Prior (within 6 months of Screening) or concomitant use of any vesicular monoamine transporter 2 (VMAT2) inhibitor (that is, valbenazine, reserpine, tetrabenazine, deutetrabenazine); or a history of intolerance to VMAT2 inhibitors

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10 [Time Frame: Baseline, Week 10]

Secondary endpoints 2

  1. Change in Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 10 [Time Frame: Baseline, Week 10]
  2. Change in Personal and Social Performance (PSP) Score from Baseline to Week 10 [Time Frame: Baseline, Week 10]

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Valbenazine

PRD9107879 · Product

Active substance
Valbenazine Ditosylate 
Substance synonyms
VALBENAZINE TOSYLATE
Other product name
NBI-98854
Pharmaceutical form
CAPSULE
Route of administration
ORAL USE
Max daily dose
80 mg milligram(s)
Max total dose
5600 mg milligram(s)
Max treatment duration
10 Week(s)
Authorisation status
Not Authorised
MA holder
NEUROCRINE BIOSCIENCES INC
Paediatric formulation
No
Orphan designation
No

Valbenazine

PRD9107880 · Product

Active substance
Valbenazine Ditosylate 
Substance synonyms
VALBENAZINE TOSYLATE
Other product name
NBI-98854
Pharmaceutical form
CAPSULE
Route of administration
ORAL USE
Max daily dose
80 mg milligram(s)
Max total dose
5600 mg milligram(s)
Max treatment duration
10 Week(s)
Authorisation status
Not Authorised
MA holder
NEUROCRINE BIOSCIENCES INC
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo for Valbenazine Capsules

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Neurocrine Biosciences Inc.

18 Total trials 11 Recruiting 6 Ended
Commercial
Sponsor organisation
Neurocrine Biosciences Inc.
Address
12790 El Camino Real
City
San Diego
Postcode
92130-2042
Country
United States

Scientific contact point

Organisation
Neurocrine Biosciences Inc.
Contact name
Neurocrine Medical Information Call Center

Public contact point

Organisation
Neurocrine Biosciences Inc.
Contact name
Neurocrine Medical Information Call Center

Third parties 9

OrganisationCity, countryDuties
Worldwide Clinical Trials Early Phase Services LLC
ORG-100032461
 Austin, United States Laboratory analysis
Q Squared Solutions Limited
ORG-100042527
 Reading, United Kingdom Laboratory analysis
Cytel Inc.
ORG-100042560
 Waltham, United States Other
Iqvia Limited
ORG-100008655
 Reading, United Kingdom On site monitoring, Code 10, Code 12, Code 2, Code 5, Data management
Medidata Solutions Inc.
ORG-100016256
 New York, United States E-data capture
Signant Health Global LLC
ORG-100040604
 Blue Bell, United States Interactive response technologies (IRT)
WCG Clinical Inc.
ORG-100040730
 Durham, United States Other
MARKEN Germany GmbH
ORG-100017196
 Kelsterbach, Germany Other
Q Squared Solutions LLC
ORG-100043195
 Durham, United States Laboratory analysis

Locations

6 EU/EEA countries · 36 investigational sites

By country

CountryMS statusPlanned subjectsSites
Czechia Ended 13 3
Germany Ended 24 4
Italy Ended 40 2
Romania Ended 52 12
Slovakia Ended 30 8
Spain Ended 40 7
Rest of world
Colombia, Mexico, United States
 — 201 —

Investigational sites

Czechia

3 sites · Ended
Clintrial s.r.o.
Clintrial, Pocernicka 1427/16, Strasnice, Prague 10
A-Shine s.r.o.
A-Shine s.r.o, Sumavska 2, Vychodni Predmesti, Plzen 3
Neuropsychiatrie s.r.o.
Neuropsychiatrie s.r.o, Terronska 580/19, Bubenec, Prague 6

Germany

4 sites · Ended
Vivantes Netzwerk fuer Gesundheit GmbH
Department für seelische Gesundheit, Am Nordgraben 2/1, Wittenau, Berlin
Goethe University Frankfurt
Klinik für Psychiatrie, Psychosomatik und Psychotherapie, Heinrich-Hoffmann-Strasse 10, Niederrad, Frankfurt Am Main
Praxis Dr. med. Kirsten Hahn
N/A, Florastr. 44, 13187, Berlin
ZNS GmbH Zentrum fuer Neurologisch-Psychiatrische Studien Gutachten und medizinische Fortbildung Siegen
Zentrum für Neurologisch-Psychatrische Studien, Weidenauer Strasse 84, Weidenau, Siegen

Italy

2 sites · Ended
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Psichiatria, Via Francesco Sforza 28, 20122, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Dipartimento di Salute Mentale e delle Dipendenze, Piazzale Spedali Civili 1, 25123, Brescia

Romania

12 sites · Ended
Institutul De Psihiatrie Socola Iasi
III Acuti, Soseaua Bucium 36, 700282, Jassi
Institutul De Psihiatrie Socola Iasi
V Acuti, Soseaua Bucium 36, 700282, Jassi
Mediab S.R.L.
Psychiatry, Apartament I-II, Strada Marinescu Gheorghe Nr 8a, Targu Mures
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Sectia Clinica Psihiatrie XII, Soseaua Berceni 10, 041915, Bucharest
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
Psihiatrie I, Strada Prundului 7-9, 500123, Brasov
Spitalul Clinic Judetean Mures
Clinica Psihiatrie I, Str Gh Marinescu Nr 46, 540136, Targu Mures
Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian
Psychiatry, Strada Ing Cristian Pascal 25-27 Sector 6, 060222, Bucharest
Spitalul Clinic Judetean De Urgenta Bihor
Psihiatrie 2, Strada Pasteur Louis Nr 26, 410154, Oradea
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Sectia Clinica Psihiatrie III, Soseaua Berceni 10, 041915, Bucharest
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Centrul de Sanatate Mintala, Str Argeselu nr 8, Sector 4, Bucuresti
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
Psihiatrie II, Strada Prundului 7-9, 500123, Brasov
Institutul Privat de Cercetari Melchisedec, pentru Boli Autoimune, Ereditare si Rare - IPCM
Psihiatrie, Strada Amarandia nr. 21, Romania, Craiova

Slovakia

8 sites · Ended
Univerzitna nemocnica L. Pasteura Kosice
Psychiatrická klinika, Rastislavova 43, Juh, Kosice
PsychoLine s.r.o.
Psychiatrická ambulancia, Dobsinskeho 4861, 97901, Rimavska Sobota
Nemocnica s poliklinikou Prievidza so sídlom v Bojniciach
Psychiatria, Nemocničná 581/2, 972 01, Bojnice
Dana Ignjatovičová, spol. s.r.o.,
Psychiatrická ambulancia, Bakossova 1693/36, 974 01, Banská Bystrica
Svet Zdravia a.s.
Psychiatria, Einsteinova 25, 851 01, Petrzalka
MENTUM, s.r.o.
Psychiatrická ambulancia, Ruzinovska 10, 820 07, Bratislava
Crystal Comfort s.r.o.
Psychiatrická ambulancia, M R Stefanika 2427, 093 01, Vranov Nad Toplou
Bona Medic s.r.o.
Psychiatrická ambulancia, Bernolakova 24, 953 01, Zlate Moravce

Spain

7 sites · Ended
Institucion Hospitalaria Hestia Palau
Psiquiatría, c/ de Sant Antoni Maria Claret, 135, Barcelona
Parc De Salut Mar
Psiquiatría, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Ramon Y Cajal
Psiquiatría, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
University Hospital Virgen Del Rocio S.L.
Psiquiatría, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital De La Santa Creu I Sant Pau
Psiquiatría, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario Fundacion Alcorcon
Psiquiatría, Calle Budapest 1, 28022, Madrid
Hospital Clinic De Barcelona
Psiquiatría, Calle Villarroel 170, 08036, Barcelona

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
Results Justification 2022-502233-25-00
SUM-55551
 2024-11-04T22:29:58 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
Results Justification 2022-502233-25-00 2024-11-04T22:29:48 Submitted Laypersons Summary of Results

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) Results Justification 2022-502233-25-00 1
Summary of results (for publication) Results Justification 2022-502233-25-00 1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-12-09 Spain Acceptable with conditions
2023-04-10
 2023-06-07
2 SUBSTANTIAL MODIFICATION SM-2 2023-08-01 Spain Acceptable
2023-09-15
 2023-09-15

Related clinical trials