An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania

NCT07288320 | Recruiting Phase 2 FDA Drug

• 1 other identifier: NBI-1117568-BPD2036
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

Brief Summary

The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or without mixed features.

Conditions

Bipolar I Disorder; Mania

Keywords

Bipolar I Disorder; Mania; NBI-1117568

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21

  Baseline, Day 21

Secondary Outcomes (1)

• Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score at Day 21

  Baseline, Day 21

Study Arms (2)

NBI-1117568

EXPERIMENTAL

Participants will receive NBI-1117568.

Drug: NBI-1117568

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matching NBI-1117568.

Drug: Placebo

Interventions

NBI-1117568 DRUG

Oral administration

NBI-1117568

Placebo DRUG

Oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has a primary diagnosis of bipolar I disorder.
• The participant has had at least 1 prior documented manic episode that required treatment.
• The participant is experiencing an acute manic episode or manic episode with mixed features, with or without psychotic symptoms.

You may not qualify if:

• Any unstable or poorly controlled medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results), or malignancy within 90 days before the start of screening.
• Primary diagnosis is not bipolar I disorder.
• History of clozapine treatment for treatment-resistant psychosis.
• History of psychiatric hospitalization(s) for ≥30 consecutive days during the 90 days before the start of screening.

Sponsors & Collaborators

• Neurocrine Biosciences: lead

Study Sites (6)

Neurocrine Clinical Site

Garden Grove, California, 92845, United States

RECRUITING

Neurocrine Clinical Site

Hollywood, California, 33024, United States

RECRUITING

Neurocrine Clinical Site

San Diego, California, 92123, United States

RECRUITING

Neurocrine Clinical Site

Atlanta, Georgia, 30331, United States

RECRUITING

Neurocrine Clinical Site

Gaithersburg, Maryland, 20877, United States

RECRUITING

Neurocrine Clinical Site

Marlton, New Jersey, 08053, United States

RECRUITING

MeSH Terms

Conditions

Mania

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Development Lead

  Neurocrine Biosciences

  STUDY DIRECTOR

Central Study Contacts

Neurocrine Medical Information Call Center

CONTACT

1-877-641-3461; medinfo@neurocrine.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 17, 2025
• Study Start: December 24, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)