SchizophreniaPhase 2NCT05545111
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia
A Phase 2 study testing NBI-1117568 in people with Schizophrenia, run by Neurocrine Biosciences at 15 sites in United States.
Trial summary
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of NBI-1117568 compared with placebo in adult subjects with a primary diagnosis of schizophrenia, who are experiencing an… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- NBI-1117568
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 15 sitesUnited States
- Study dates
- 4 Oct 2022to 10 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Completed informed consent.
- Subject has a primary diagnosis of schizophrenia.
- The subject is experiencing an acute exacerbation or relapse of symptoms and currently requires hospitalization.
- Subjects taking prohibited medications, including antipsychotics, must discontinue before study participation
- Subject is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements.
Who cannot join
- An unstable medical condition, chronic disease, or malignancy.
- Considered by the investigator to be at imminent risk of suicide or injury to self or others.
- Diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening.
- Positive alcohol test or drug screen for disallowed substances.
- Have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the subject is not capable of adhering to the protocol requirements.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Neurocrine Clinical Site
Austin, Texas, 78754
Neurocrine Clinical Site
Berlin, New Jersey, 08053
Neurocrine Clinical Site
DeSoto, Texas, 75115
Neurocrine Clinical Site
Gaithersburg, Maryland, 20877
Neurocrine Clinical Site
Lemon Grove, California, 91945
Neurocrine Clinical Site
Little Rock, Arkansas, 72211
Neurocrine Clinical Site
Miami Lakes, Florida, 33016
Neurocrine Clinical Site
North Canton, Ohio, 44720
Neurocrine Clinical Site
Oakland Park, Florida, 33334
Neurocrine Clinical Site
Pico Rivera, California, 90660
Neurocrine Clinical Site
Richardson, Texas, 75080
Neurocrine Clinical Site
Rogers, Arkansas, 72758
Neurocrine Clinical Site
San Diego, California, 92123
Neurocrine Clinical site
St Louis, Missouri, 63141
Neurocrine Clinical Site
Torrance, California, 90502
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of NBI-1117568 compared with placebo in adult subjects with a primary diagnosis of schizophrenia, who are experiencing an acute exacerbation or relapse of symptoms.
- Conditions
- Schizophrenia
- Being tested
- NBI-1117568, Placebo
- Keywords
- schizophrenia, NBI-1117568, muscarinic
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI-1117568Drug
Active treatment with orally administered NBI-1117568
PlaceboDrug
Placebo matching NBI-1117568
| Study group | Role | What they receive |
|---|---|---|
| Dose Level A | Experimental | Participant administered Dose Level A (6 weeks) Receives: Drug: NBI-1117568 |
| Dose Level B | Experimental | Participant administered Dose Level B (6 weeks) Receives: Drug: NBI-1117568 |
| Dose Level C | Experimental | Participant administered Dose Level C (6 weeks) Receives: Drug: NBI-1117568 |
| Dose Level D | Experimental | Participant administered Dose Level D (6 weeks) Receives: Drug: NBI-1117568 |
| Placebo Schedule | Placebo comparator | Participant administered placebo (6 weeks) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6
The PANSS evaluates the severity of various symptoms of schizophrenia, and is commonly used to measure symptom reduction in patients taking antipsychotics. Each item is scored on a 7-point severity scale (1=absent; 2=minimal; 3=mild; 4=moderate; 5=moderate severe; 6=severe; 7=extreme). The PANSS total score is derived from the summation of each item. A higher score indicates greater severity.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start4 Oct 2022
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 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
- NCT05545111
- Sponsor's protocol ID
- NBI-1117568-SCZ2028
- Status last verified
- Jul 2025
- First submitted
- 14 Sep 2022
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
- ClinicalTrials.gov ID
- NCT05545111
- Acronym / sponsor ID
- NBI-1117568-SCZ2028
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, NBI-1117568, muscarinic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of NBI-1117568 compared with placebo in adult subjects with a primary diagnosis of schizophrenia, who are experiencing an acute exacerbation or relapse of symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Level A | Experimental | Drug: NBI-1117568Participant administered Dose Level A (6 weeks) |
| Dose Level B | Experimental | Drug: NBI-1117568Participant administered Dose Level B (6 weeks) |
| Dose Level C | Experimental | Drug: NBI-1117568Participant administered Dose Level C (6 weeks) |
| Dose Level D | Experimental | Drug: NBI-1117568Participant administered Dose Level D (6 weeks) |
| Placebo Schedule | Placebo comparator | Drug: PlaceboParticipant administered placebo (6 weeks) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Completed informed consent.
- Subject has a primary diagnosis of schizophrenia.
- The subject is experiencing an acute exacerbation or relapse of symptoms and currently requires hospitalization.
- Subjects taking prohibited medications, including antipsychotics, must discontinue before study participation
- Subject is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements.
Key exclusion criteria (5 listed)
- An unstable medical condition, chronic disease, or malignancy.
- Considered by the investigator to be at imminent risk of suicide or injury to self or others.
- Diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening.
- Positive alcohol test or drug screen for disallowed substances.
- Have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the subject is not capable of adhering to the protocol requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBI-1117568Active treatment with orally administered NBI-1117568 | Drug | Dose Level A, Dose Level B, Dose Level C, Dose Level D |
| PlaceboPlacebo matching NBI-1117568 | Drug | Placebo Schedule |
Primary outcome
Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6
Time frame: Baseline and Week 6
The PANSS evaluates the severity of various symptoms of schizophrenia, and is commonly used to measure symptom reduction in patients taking antipsychotics. Each item is scored on a 7-point severity scale (1=absent; 2=minimal; 3=mild; 4=moderate; 5=moderate severe; 6=severe; 7=extreme). The PANSS total score is derived from the summation of each item. A higher score indicates greater severity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Lead study director
Neurocrine Biosciences
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NBI-1117568 in people with Schizophrenia, run by Neurocrine Biosciences at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6 (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.