Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia

Sponsor

Neurocrine Biosciences (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05110157

Collaborator

(none)

400

Enrollment

Locations

Arms

23.1

Anticipated Duration (Months)

18.2

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective for this study is to evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in subjects who have inadequate response to antipsychotic treatment.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Placebo Drug: Valbenazine	Phase 3

Detailed Description

Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of valbenazine when administered orally once daily as adjunctive treatment in subjects with schizophrenia who have had an inadequate response to antipsychotics. The study will enroll approximately 400 subjects with a diagnosis of schizophrenia. The expected duration of study participation for each subject is approximately 16 weeks.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 29, 2021

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo once daily.	Drug: Placebo Oral capsules
Experimental: Vesicular monoamine transporter 2 (VMAT2) inhibitor Valbenazine once daily	Drug: Valbenazine Oral capsules Other Names: NBI-98854

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Placebo once daily.

Drug: Placebo

Oral capsules

Experimental: Vesicular monoamine transporter 2 (VMAT2) inhibitor

Valbenazine once daily

Drug: Valbenazine

Oral capsules

Other Names:

NBI-98854

Outcome Measures

Primary Outcome Measures

Change in PANSS total score from baseline to Week 10 [Baseline to week 10]

Secondary Outcome Measures

Change in CGI-S score from baseline to Week 10 [Baseline to week 10]
Change in Personal and Social Performance Scale (PSP) score from baseline to Week 10 [Baseline to week 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

• Subjects must meet all of the following inclusion criteria:

Completed written informed consent for adult subjects or written and witnessed pediatric assent from the subject and written informed consent from the subject's legal guardian in accordance with the IRB/IEC and according to local laws and regulations.
At the time of signing the informed consent (or assent for pediatric subjects), subject must be ≥13 years of age.
Medically confirmed 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 prior to screening.
Plasma levels for at least 1 of the subject's antipsychotic medications must be detectable by an available assay.
The subject is treated with a stable regimen antipsychotic medication.
Must meet all of the following criteria at screening and Day 1:

Positive and Negative Syndrome Scale (PANSS) total score ≥70
PANSS score of ≥4 on at least 1 of the following:
P1 (delusions)
P3 (hallucinations)
P6 (suspiciousness)
G9 (unusual thought content)
Clinical Global Impression of Severity (CGI S) score ≥ 4
Stable background antipsychotic medication dose between screening and Day 1
Stable PANSS total score between screening and Day 1

The subject is outpatient with stable symptomatology
The subject must have an adult informant (eg, a family member, social worker, caseworker, residential facility staff, or nurse).
Female subjects of childbearing potential who have undergone menarche must agree to use contraception consistently from screening until 30 days after the last dose of study drug or final study visit, whichever is longer.
Male subjects must agree to use contraception consistently from screening until 30 days after last dose of study treatment.

Exclusion Criteria:

Subjects 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. This criterion must be reconfirmed prior to the first dose of study treatment on Day
Known hypersensitivity to any component of the formulation of valbenazine.
Has history of treatment resistant schizophrenia.
Evidence of depression as measured by a Calgary Depression Scale for Schizophrenia (CDSS) score >8 at screening and Day 1.
Subjects with any suicidal behavior or suicidal ideation within 6 months before screening or on Day 1.
Diagnosis of moderate or severe substance use disorder within the 6 months prior to screening.
Have a clinically significant unstable medical condition within 60 days prior to screening in the judgement of the investigator (30 days prior to screening for minor medical conditions) 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 VMAT2 inhibitors.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neurocrine Clinical Site	Phoenix	Arizona	United States	85012
2	Neurocrine Clinical Site	Culver City	California	United States	90230
3	Neurocrine Clinical Site	Garden Grove	California	United States	92845
4	Neurocrine Clinical Site	Lemon Grove	California	United States	91945
5	Neurocrine Clinical Site	Long Beach	California	United States	90502
6	Neurocrine Clinical Site	Oceanside	California	United States	92056
7	Neurocrine Clinical Site	Pico Rivera	California	United States	90660
8	Neurocrine Clinical Site	San Diego	California	United States	92102
9	Neurocrine Clinical Site	San Diego	California	United States	92103
10	Neurocrine Clinical Site	Santa Ana	California	United States	92705
11	Neurocrine Clinical Site	Torrance	California	United States	90502
12	Neurocrine Clinical Site	Hialeah	Florida	United States	33012
13	Neurocrine Clinical Site	Hialeah	Florida	United States	33013
14	Neurocrine Clinical Site	Miami	Florida	United States	33137
15	Neurocrine Clinical Site	Saint Louis	Missouri	United States	63125
16	Neurocrine Clinical Site	Saint Louis	Missouri	United States	63128
17	Neurocrine Clinical Site	Las Vegas	Nevada	United States	89102
18	Neurocrine Clinical Site	New York	New York	United States	10035
19	Neurocrine Clinical Site	Dayton	Ohio	United States	45417
20	Neurocrine Clinical Site	Oklahoma City	Oklahoma	United States	73112
21	Neurocrine Clinical Site	Austin	Texas	United States	78754
22	Neurocrine Clinical Site	DeSoto	Texas	United States	75115