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

Part of paid clinical trials in Garden Grove, California.

Sponsor
Neurocrine Biosciences
Study ID
NCT07288320
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • NBI-1117568 — DRUG
    Oral administration
  • Placebo — DRUG
    Oral administration

Study Details

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.

Key Dates

Start date
Dec 24, 2025
Status verified
Mar 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NBI-1117568
    Participants will receive NBI-1117568.
  • Placebo Comparator: Placebo
    Participants will receive placebo matching NBI-1117568.

Primary Outcome Measure

Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21 [ Time Frame: Baseline, Day 21 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Neurocrine Clinical SiteGarden GroveCalifornia92845-
Neurocrine Clinical SiteHollywoodCalifornia33024-
Neurocrine Clinical SiteSan DiegoCalifornia92123-
Neurocrine Clinical SiteAtlantaGeorgia30331-
Neurocrine Clinical SiteGaithersburgMaryland20877-
Neurocrine Clinical SiteMarltonNew Jersey08053-

Find similar trials in Garden Grove, CA

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
Neurocrine Clinical Site· Garden Grove, CANeurocrine Clinical Site· Hollywood, CANeurocrine Clinical Site· San Diego, CANeurocrine Clinical Site· Atlanta, GANeurocrine Clinical Site· Gaithersburg, MDNeurocrine Clinical Site· Marlton, NJ

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