Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
Key facts
- Where
- Brasov, Bucharest, Bucuresti, Craiova, Jassi, Oradea és Târgu Mureş, RomániaSee the 9 sites
- Phase
- 3. fázis
Where in Románia
- Spitalul Clinic De Psihiatrie Si Neurologie BrasovBrasov, RomániaNo longer taking part
- Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. StelianBucharest, RomániaNo longer taking part
- Spitalul Clinic de Psihiatrie Prof Dr Alexandru ObregiaBucharest, RomániaNo longer taking part
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru ObregiaBucuresti, RomániaNo longer taking part
- Institutul Privat de Cercetari Melchisedec, pentru Boli Autoimune, Ereditare si Rare - IPCMCraiova, RomániaNo longer taking part
- Institutul De Psihiatrie Socola IasiJassi, RomániaNo longer taking part
- Spitalul Clinic Judetean De Urgenta BihorOradea, RomániaNo longer taking part
- Mediab S.R.L.Târgu Mureş, RomániaNo longer taking part
- Spitalul Clinic Judeţean MureşTârgu Mureş, RomániaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neurocrine Biosciences Inc.
- Trial code
- EU 2022-502233-25-00
- Record updated
- 2023. szeptember 26.
- Original description
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 treatmentRead full original descriptionShow less
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
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
Inclusion: 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).
Exclusion: 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; Has a history of treatment resistant schizophrenia; 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.