Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia

Part of paid clinical trials in Bryant, Arkansas.

Sponsor
Neurocrine Biosciences
Study ID
NCT07365462
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Tardive Dyskinesia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • NBI-1065890 — DRUG
    Oral administration
  • Placebo — DRUG
    Oral administration

Study Details

The primary objective of this study is to evaluate the efficacy of NBI-1065890 compared with placebo for the treatment of tardive dyskinesia (TD) in adult participants.

Key Dates

Start date
Feb 6, 2026
Status verified
May 2026
Primary completion
Feb 28, 2027
Completion
Mar 31, 2027

Study Design

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

Arms

  • Experimental: NBI-1065890
    Participants will receive NBI-1065890.
  • Placebo Comparator: Placebo
    Participants will receive placebo matching NBI-1065890.

Primary Outcome Measure

Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 8 Based on the Blinded Central AIMS Video Raters' Assessment [ Time Frame: Baseline and Week 8 ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Neurocrine Clinical SiteBryantArkansas72022-
Neurocrine Clinical SiteChinoCalifornia91710-
Neurocrine Clinical SiteHuntington BeachCalifornia92648-
Neurocrine Clinical SiteLong BeachCalifornia90807-
Neurocrine Clinical SiteTemeculaCalifornia92591-
Neurocrine Clinical SiteTorranceCalifornia90501-
Neurocrine Clinical SiteBoca RatonFlorida33486-
Neurocrine Clinical SiteBonita SpringsFlorida34134-
Neurocrine Clinical SiteHialeahFlorida33012-
Neurocrine Clinical SiteMiamiFlorida33176-
Neurocrine Clinical SiteOrange CityFlorida32763-
Neurocrine Clinical SiteTampaFlorida33629-
Neurocrine Clinical SiteMariettaGeorgia30060-
Neurocrine Clinical SiteLincolnNebraska68526-
Neurocrine Clinical SiteBeachwoodOhio44122-
Neurocrine Clinical SiteFort WorthTexas76104-
Neurocrine Clinical SiteHoustonTexas77030-

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Neurocrine Clinical Site· Bryant, ARNeurocrine Clinical Site· Chino, CANeurocrine Clinical Site· Huntington Beach, CANeurocrine Clinical Site· Long Beach, CANeurocrine Clinical Site· Temecula, CANeurocrine Clinical Site· Torrance, CA

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