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Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia (ERUDITE)

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Luvadaxistat
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, Cognitive Impairment, Luvadaxistat, NBI-1065844, TAK-831, CIAS, BAC, ERUDITE, Neurocrine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Participants must meet all of the following inclusion criteria:

  1. Completed written informed consent
  2. Participant must be 18 to 50 years of age (inclusive) and able to comply with all protocol procedures.
  3. Diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
  4. The initial diagnosis of schizophrenia must be ≥1 year before screening.
  5. The participant is currently receiving a stable regimen of psychotropic medications
  6. Participant has stable symptomatology ≥3 months before the screening visit.
  7. The participant must have an adult informant.
  8. A body weight of at least 45 kilograms (kg) and a body mass index (BMI) of 18.0 to 45.0 kg/meter squared (m^2), inclusive.

Key Exclusion Criteria

Participants will be excluded from the study if they meet any of the following criteria:

  1. Pregnant or breastfeeding or plans to become pregnant during the study.
  2. Exhibit more than a minimal level of extrapyramidal signs/symptoms .
  3. Schizophrenia diagnosis occurred before 12 years of age.
  4. Lifetime diagnosis of schizoaffective disorder, bipolar disorder, or obsessive-compulsive disorder.
  5. Recent occurrence of panic disorder, depressive episode, or other comorbid psychiatric conditions.
  6. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within 6 months before screening.
  7. Diagnosis of moderate or severe substance use disorder (with the exception of nicotine dependence) within 12 months prior to screening.
  8. Positive drug screen for disallowed substances
  9. Any other medical or psychiatric condition or cognitive impairment that may interfere with study conduct or clinical assessments.

Sites / Locations

  • Neurocrine Clinical SiteRecruiting
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  • Neurocrine Clinical SiteRecruiting
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  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical SiteRecruiting
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  • Neurocrine Clinical SiteRecruiting
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  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical Site
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical Site
  • 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 Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • 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 Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical Site
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical Site
  • Neurocrine Clinical SiteRecruiting
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Luvadaxistat treatment schedule 1

Luvadaxistat treatment schedule 2

Arm Description

Placebo daily

Luvadaxistat daily

Luvadaxistat daily

Outcomes

Primary Outcome Measures

Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) Composite Score

Secondary Outcome Measures

Change From Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Score
Change From Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
Change From Baseline on the Clinical Global Impression-Severity Scale (CGI-S) Score

Full Information

First Posted
December 17, 2021
Last Updated
July 18, 2023
Sponsor
Neurocrine Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT05182476
Brief Title
Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia
Acronym
ERUDITE
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Subjects With Cognitive Impairment Associated With Schizophrenia, Followed by Open-Label Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
March 2025 (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
No

5. Study Description

Brief Summary
Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.
Detailed Description
A Phase 2, randomized, double-blind, parallel, placebo-controlled study with a 6- or 12-month open-label extension. The study is designed to evaluate the efficacy, safety and tolerability, and pharmacokinetics (PK) of treatment with luvadaxistat when administered orally once daily as an adjunctive treatment on improving symptoms of cognitive impairment associated with schizophrenia (CIAS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Cognitive Impairment, Luvadaxistat, NBI-1065844, TAK-831, CIAS, BAC, ERUDITE, Neurocrine

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo daily
Arm Title
Luvadaxistat treatment schedule 1
Arm Type
Experimental
Arm Description
Luvadaxistat daily
Arm Title
Luvadaxistat treatment schedule 2
Arm Type
Experimental
Arm Description
Luvadaxistat daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Luvadaxistat
Other Intervention Name(s)
NBI-1065844, TAK-831
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) Composite Score
Time Frame
Baseline, Day 98
Secondary Outcome Measure Information:
Title
Change From Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Score
Time Frame
Baseline, Day 98
Title
Change From Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
Time Frame
Baseline, Day 98
Title
Change From Baseline on the Clinical Global Impression-Severity Scale (CGI-S) Score
Time Frame
Baseline, Day 98

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Participants must meet all of the following inclusion criteria: Completed written informed consent. Participant must be 18 to 50 years of age (inclusive) and able to comply with all protocol procedures. Diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). The initial diagnosis of schizophrenia must be ≥1 year before screening. The participant is currently receiving a stable regimen of psychotropic medications. Participant has stable symptomatology ≥3 months before the screening visit. The participant must have an adult informant. A body weight of at least 45 kilograms (kg) and a body mass index (BMI) of 18.0 to 45.0 kg/meter squared (m^2), inclusive. Key Exclusion Criteria Participants will be excluded from the study if they meet any of the following criteria: Pregnant or breastfeeding or plans to become pregnant during the study. Exhibit more than a minimal level of extrapyramidal signs/symptoms. Schizophrenia diagnosis occurred before 12 years of age. Lifetime diagnosis of schizoaffective disorder, bipolar disorder, or obsessive-compulsive disorder. Recent occurrence of panic disorder, depressive episode, or other comorbid psychiatric conditions. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within 6 months before screening. Diagnosis of moderate or severe substance use disorder (with the exception of nicotine dependence) within 12 months prior to screening. Positive drug screen for disallowed substances. Any other medical or psychiatric condition or cognitive impairment that may interfere with study conduct or clinical assessments.
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
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine ClinicalSite
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
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
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
San Rafael
State/Province
California
ZIP/Postal Code
94901
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Withdrawn
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
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Bonita Springs
State/Province
Florida
ZIP/Postal Code
34134
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Homestead
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Okeechobee
State/Province
Florida
ZIP/Postal Code
34972
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32502
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33629
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63125
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Fairlawn
State/Province
Ohio
ZIP/Postal Code
44333
Country
United States
Individual Site Status
Not yet 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
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Plzen
ZIP/Postal Code
301 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Culiacan
ZIP/Postal Code
80230
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Guadalajara
ZIP/Postal Code
44100
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Leon
ZIP/Postal Code
37000
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Monterrey
ZIP/Postal Code
64310
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
San Luis Potosí
ZIP/Postal Code
78213
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Gornja Toponica
ZIP/Postal Code
18202
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Kovin
ZIP/Postal Code
26220
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Novi Kneževac
ZIP/Postal Code
23330
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Neurocrine Clinical Site
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia

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