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RecruitingNCT07227818

NBI-1117568 to help prevent relapse in adults with schizophrenia

About this titleRead the official source — NCT07227818

This study evaluates the safety and effectiveness of NBI-1117568 for people with schizophrenia.

Medication studyAges 18–65United States + Serbia
The study in practice

Understand this study

What is this study about?

This study evaluates the safety and effectiveness of NBI-1117568 for people with schizophrenia.

Who could participate?

Listed age limits: 18 years to 65 years.

What will I do during this study?

Everyone first receives open-label NBI-1117568 during a stabilization period. Participants who have a stable response are then randomly assigned to continue NBI-1117568 or switch to placebo (an inactive comparison treatment) during the double-blind phase.

Listed locations
Garden Grove and 24 more locationsSee all locations and recruitment
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.

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What to know before participating

A point to clarify

This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?

Study clarity

Things to check before joining

Study start dateStarted: December 16, 2025
Recruitment status
Recruiting
Enrollment listed in the registry
560
Sponsor
Neurocrine Biosciences
Sponsor type
Biotech company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, Serbia
Age range
From 18 Years to 65 Years
Official registry ID
NCT07227818
Official title
Show the full official title

A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy of NBI-1117568 in Preventing Relapse of the Symptoms of Schizophrenia and to Assess the Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia

Recruitment & locations

Currently recruiting

Garden Grove, United States · La Habra, United States · Lemon Grove, United States

20 more locations
  • Oceanside, United States
  • Torrance, United States
  • West Hills, United States
  • Hollywood, United States
  • Maitland, United States
  • Miami, United States
  • Tampa, United States
  • West Palm Beach, United States
  • Atlanta, United States
  • Boston, United States
  • Flowood, United States
  • Marlton, United States
  • Cedarhurst, United States
  • New York, United States
  • The Bronx, United States
  • DeSoto, United States
  • Bellevue, United States
  • San Juan, Puerto Rico
  • Gornja Toponica, Serbia
  • Kragujevac, Serbia

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FAQ

Questions about this study

What is this study about?

This study evaluates the safety and effectiveness of NBI-1117568 for people with schizophrenia.

Who is behind this study?

The study sponsor is Neurocrine Biosciences, a biotech company.

Does this study involve medication?

Yes. The study involves medication, including NBI-1117568 and Placebo.

Who can participate?

Listed age limits: 18 years to 65 years.

Is this study still recruiting?

The registry lists this study as recruiting.

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