SchizophreniaPhase 3NCT05654870
Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
A Phase 3 study testing Valbenazine in people with Schizophrenia, run by Neurocrine Biosciences at 3 sites in United States.
Trial summary
This primary objective for this study is to evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in participants who have inadequate response to antipsychotic treatment. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Valbenazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Jan 2023to 8 Nov 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Neurocrine Clinical Site
Atlanta, Georgia, 30328
Neurocrine Clinical Site
Coral Gables, Florida, 33134
Neurocrine Clinical Site
San Jose, California, 95124
About this study
Official title: 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
This primary objective for this study is to evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in participants who have inadequate response to antipsychotic treatment.
- Conditions
- Schizophrenia
- Being tested
- Valbenazine, Placebo
- Keywords
- schizophrenia, valbenazine, antipsychotic, VMAT2, NBI-98854, dopamine, PANSS, Adjunctive
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValbenazineDrug
Also called NBI-98854
Oral treatment
PlaceboDrug
Placebo matching valbenazine
| Study group | Role | What they receive |
|---|---|---|
| Valbenazine | Experimental | Valbenazine once daily Receives: Drug: Valbenazine |
| Placebo | Placebo comparator | Placebo once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10
Measured: Baseline, Week 10
Secondary outcomes (2)
Change in Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 10
Measured: Baseline, Week 10
Change in Personal and Social Performance (PSP) Score from Baseline to Week 10
Measured: Baseline, Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start5 Jan 2023
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Why it stopped: Study ATS3020 was closed due to business reasons. Neurocrine Biosciences will continue to conduct study ATS3019 (NCT05110157). There were no unexpected safety findings for this compound that motivated the decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Lead, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654870
- Sponsor's protocol ID
- NBI-98854-ATS3020
- Status last verified
- Nov 2024
- First submitted
- 8 Dec 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No