Print

Purpose

This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participant has a primary diagnosis of schizophrenia - Participants taking prohibited medications, including antipsychotics, must discontinue before study participation - Participant must reside in a stable housing situation

Exclusion Criteria

  • Participant has known hypersensitivity to any component of the formulation of NBI-1117568 - Participant has an unstable or poorly controlled medical condition or chronic disease - Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others - Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening - Participant has a positive alcohol test or drug screen for disallowed substances - Participant has a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements. Note: Other protocol-specified inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NBI-1117568 		Participants will receive NBI-1117568 once daily (QD) orally for up to 36 months.
  • Drug: NBI-1117568
    NBI-1117568 will be administered per schedule specified in the arm description.

Recruiting Locations

Neurocrine Clinical Site
Bryant, Arkansas 72022

Neurocrine Clinical Site
Little Rock, Arkansas 72211

Neurocrine Clinical Site
Chino, California 91710

Neurocrine Clinical Site
Culver City, California 90230

Neurocrine Clinical Site
Garden Grove, California 92845

Neurocrine Clinical Site
La Habra, California 90631

Neurocrine Clinical Site
Lemon Grove, California 91945

Neurocrine Clinical Site
Oceanside, California 92056

Neurocrine Clinical Site
Pico Rivera, California 90660

Neurocrine Clinical Site
Riverside, California 92506

Neurocrine Clinical Site
San Diego, California 92123

Neurocrine Clinical Site
Sherman, California 91403

Neurocrine Clinical Site
Torrance, California 90504

Neurocrine Clinical Site
West Hills, California 91307

Neurocrine Clinical Site
Atlantis, Florida 30328

Neurocrine Clinical Site
Aventura, Florida 33108

Neurocrine Clinical Site
Doral, Florida 33178

Neurocrine Clinical Site
Hollywood, Florida 33024

Neurocrine Clinical Site
Maitland, Florida 32751

Neurocrine Clinical Site
Miami, Florida 33122

Neurocrine Clinical Site
Miami Lakes, Florida 33016

Neurocrine Clinical Site
Tampa, Florida 33629

Neurocrine Clinical Site
West Palm Beach, Florida 33407

Neurocrine Clinical Site
Atlanta, Georgia 30328

Neurocrine Clinical Site
Atlanta, Georgia 30331

Neurocrine Clinical Site
Decatur, Georgia 30030

Neurocrine Clinical Sites
Peachtree Corners, Georgia 30071

Neurocrine Clinical Site
Chicago, Illinois 60640

Neurocrine Clinical Site
Gaithersburg, Maryland 20877

Neurocrine Clinical Site
Boston, Massachusetts 02116

Neurocrine Clinical Site
Watertown, Massachusetts 02472

Neurocrine Clinical Site
Flowood, Mississippi 39232

Neurocrine Clinical Site
St Louis, Missouri 63141

Neurocrine Clinical Site
Marlton, New Jersey 08053

Neurocrine Clinical Site
Cedarhurst, New York 11516

Neurocrine Clinical Site
New York, New York 10029

Neurocrine Clinical Site
New York, New York 10036

Neurocrine Clincial Site
Staten Island, New York 10314

Neurocrine Clinical Sites
The Bronx, New York 10461

Neurocrine Clinical Sites
North Canton, Ohio 44720

Neurocrine Clinical Site
Philadelphia, Pennsylvania 19104

Neurocrine Clinical Site
Austin, Texas 78754

Neurocrine Clinical Site
DeSoto, Texas 75115

Neurocrine Clinical Site
Houston, Texas 77043

Neurocrine Clinical Sites
Orem, Utah 84058

Neurocrine Clinical Site
Orem, Utah 84058

Neurocrine Clinical Site
Bellevue, Washington 98007

More Details

Status
Recruiting
Sponsor
Neurocrine Biosciences

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.