2022-502233-25-00CompletedPhase 3

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects with Schizophrenia

Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Sept 2023

Next steps

Brief summary (registry, in English)

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

Status (registry): Completed
Phase (registry): Phase 3
Study type: Interventional
Enrollment: 199 (actual)
First submitted: 9 Dec 2022
Start date: 2 Sept 2023
Lead sponsor: Neurocrine Biosciences Inc.
Diseases: Schizophrenia
EU CT number: 2022-502233-25-00

What you commit to

Study type: Interventional · Phase 3
Participants enrolled: 199
33 sites in 6 countries
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

Has a history of treatment resistant schizophrenia

Lab values

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

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (33)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
A-Shine s.r.o.	Plzen 3	Czechia	Completed
Clintrial s.r.o.	Prague 10	Czechia	Completed
Neuropsychiatrie s.r.o.	Prague 6	Czechia	Completed
Praxis Dr. med. Kirsten Hahn	Berlin	Germany	Completed
Vivantes Netzwerk fuer Gesundheit GmbH	Berlin	Germany	Completed
Goethe University Frankfurt	Frankfurt Am Main	Germany	Completed
ZNS GmbH Zentrum fuer Neurologisch-Psychiatrische Studien Gutachten und medizinische Fortbildung Siegen	Siegen	Germany	Completed
Hospital de la Santa Creu i Sant Pau	Barcelona	Spain	Completed
Hospital Clinic de Barcelona	Barcelona	Spain	Completed
Parc De Salut Mar	Barcelona	Spain	Completed
Institucion Hospitalaria Hestia Palau	Barcelona	Spain	Completed
Hospital Universitario Fundacion Alcorcon	Madrid	Spain	Completed
Hospital Universitario Ramón y Cajal	Madrid	Spain	Completed
University Hospital Virgen Del Rocio S.L.	Sevilla	Spain	Completed
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia	Brescia	Italy	Completed
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milan	Italy	Completed
Spitalul Clinic De Psihiatrie Si Neurologie Brasov	Brasov	Romania	Completed
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia	Bucharest	Romania	Completed
Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian	Bucharest	Romania	Completed
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia	Bucuresti	Romania	Completed
Institutul Privat de Cercetari Melchisedec, pentru Boli Autoimune, Ereditare si Rare - IPCM	Craiova	Romania	Completed
Institutul De Psihiatrie Socola Iasi	Jassi	Romania	Completed
Spitalul Clinic Judetean De Urgenta Bihor	Oradea	Romania	Completed
Mediab S.R.L.	Târgu Mureş	Romania	Completed
Spitalul Clinic Judeţean Mureş	Târgu Mureş	Romania	Completed
Dana Ignjatovićová, spol. s r.o	Banská Bystrica	Slovakia	Completed
Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach	Bojnice	Slovakia	Completed
MENTUM s.r.o.	Bratislava	Slovakia	Completed
Univerzitna nemocnica L. Pasteura Kosice	Košice	Slovakia	Completed
Svet Zdravia a.s.	Petrzalka	Slovakia	Completed
PsychoLine s.r.o.	Rimavska Sobota	Slovakia	Completed
Crystal Comfort S.R.O.	Vranov nad Topľou	Slovakia	Completed
Bona Medic s.r.o.	Zlate Moravce	Slovakia	Completed

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