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Trial record 7 of 559 for:    Phase 2 | schizophrenia
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Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia

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ClinicalTrials.gov Identifier: NCT05545111
Recruitment Status : Recruiting
First Posted : September 19, 2022
Last Update Posted : December 27, 2022
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: NBI-1117568 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 4, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Level A
Participant administered Dose Level A (6 weeks)
 Drug: NBI-1117568
Active treatment with orally administered NBI-1117568
Experimental: Dose Level B
Participant administered Dose Level B (6 weeks)
 Drug: NBI-1117568
Active treatment with orally administered NBI-1117568
Experimental: Dose Level C
Participant administered Dose Level C (6 weeks)
 Drug: NBI-1117568
Active treatment with orally administered NBI-1117568
Experimental: Dose Level D
Participant administered Dose Level D (6 weeks)
 Drug: NBI-1117568
Active treatment with orally administered NBI-1117568
Placebo Comparator: Placebo Schedule
Participant administered placebo (6 weeks)
 Drug: Placebo
Placebo matching NBI-1117568


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05545111


Contacts
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Contact: Neurocrine Medical Information Call Center 877-641-3461 medinfo@neurocrine.com

Locations
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United States, Arkansas
Neurocrine Clinical Site Recruiting
Little Rock, Arkansas, United States, 72211
United States, California
Neurocrine Clinical Site Recruiting
Lemon Grove, California, United States, 91945
United States, Florida
Neurocrine Clinical Site Recruiting
Miami Lakes, Florida, United States, 33016
Neurocrine Clinical Site Recruiting
Oakland Park, Florida, United States, 33334
United States, Maryland
Neurocrine Clinical Site Recruiting
Gaithersburg, Maryland, United States, 20877
United States, New Jersey
Neurocrine Clinical Site Recruiting
Berlin, New Jersey, United States, 08053
United States, Ohio
Neurocrine Clinical Site Recruiting
North Canton, Ohio, United States, 44720
United States, Texas
Neurocrine Clinical Site Recruiting
DeSoto, Texas, United States, 75115
Sponsors and Collaborators
Neurocrine Biosciences
Investigators
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Study Director: Clinical Development Lead Neurocrine Biosciences
More Information
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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT05545111    
Other Study ID Numbers: NBI-1117568-SCZ2028
First Posted: September 19, 2022    Key Record Dates
Last Update Posted: December 27, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neurocrine Biosciences:
schizophrenia
NBI-1117568
muscarinic
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders