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Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NBI-1117568
Placebo
Sponsored by
Neurocrine Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, NBI-1117568, muscarinic

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • 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:

  • 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.

Sites / Locations

  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical siteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Dose Level A

Dose Level B

Dose Level C

Dose Level D

Placebo Schedule

Arm Description

Participant administered Dose Level A (6 weeks)

Participant administered Dose Level B (6 weeks)

Participant administered Dose Level C (6 weeks)

Participant administered Dose Level D (6 weeks)

Participant administered placebo (6 weeks)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2022
Last Updated
September 15, 2023
Sponsor
Neurocrine Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT05545111
Brief Title
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurocrine Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 acute exacerbation or relapse of symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, NBI-1117568, muscarinic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
213 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Level A
Arm Type
Experimental
Arm Description
Participant administered Dose Level A (6 weeks)
Arm Title
Dose Level B
Arm Type
Experimental
Arm Description
Participant administered Dose Level B (6 weeks)
Arm Title
Dose Level C
Arm Type
Experimental
Arm Description
Participant administered Dose Level C (6 weeks)
Arm Title
Dose Level D
Arm Type
Experimental
Arm Description
Participant administered Dose Level D (6 weeks)
Arm Title
Placebo Schedule
Arm Type
Placebo Comparator
Arm Description
Participant administered placebo (6 weeks)
Intervention Type
Drug
Intervention Name(s)
NBI-1117568
Intervention Description
Active treatment with orally administered NBI-1117568
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching NBI-1117568
Primary Outcome Measure Information:
Title
Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6
Description
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.
Time Frame
Baseline and Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neurocrine Medical Information Call Center
Phone
877-641-3461
Email
medinfo@neurocrine.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Lead
Organizational Affiliation
Neurocrine Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Neurocrine Clinical Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia

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