BHV-7000 Acute Treatment of Bipolar Mania

Part of paid clinical trials in Bentonville, Arkansas.

Sponsor
Biohaven Therapeutics Ltd.
Study ID
NCT06419582
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • BHV-7000 — DRUG
    BHV-7000 75 mg taken once daily for 21 days
  • Placebo — DRUG
    Matching placebo taken once daily for 21 days

Study Details

The purpose of this study is to determine whether BHV-7000 is a safe and effective acute treatment for manic episodes in bipolar disorder I.

Key Dates

Start date
May 28, 2024
Status verified
Dec 2025
Primary completion
Jan 15, 2025
Completion
Jan 30, 2025

Study Design

Enrollment
274 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BHV-7000
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in Young Mania Rating Scale (YMRS) total score from baseline to day 21 [ Time Frame: Baseline (day 1) to day 21 ]

Locations (32)

FacilityCityStateZIPSite coordinators
Pillar Clinical Research, LLCBentonvilleArkansas72712-
WIRGLittle RockArkansas72211-
WRNRogersArkansas72758-
Advanced Research Center, Inc.AnaheimCalifornia92805-
CIT LABellflowerCalifornia90706-
ProScience Research GroupCulver CityCalifornia90230-
Cenexel CNSGarden GroveCalifornia92845-
Synergy San DiegoLemon GroveCalifornia91945-
NRC Research InstituteOrangeCalifornia92868-
CIT IERiversideCalifornia92506-
Cenexel CNSTorranceCalifornia90504-
Cenexel - RCAHollywoodFlorida33024-
Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase SiteHollywoodFlorida33021-
LCC Medical Research InstMiamiFlorida33126-
Floridian Neuroscience InstituteMiami LakesFlorida33016-
Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase SiteMiami LakesFlorida33016-
Neuroscience Research InstituteWest Palm BeachFlorida33407-
Atlanta Center for Medical ResearchAtlantaGeorgia30331-
CenExel iResearch, LLCDecaturGeorgia30030-
CenExel iResearch, LLCSavannahGeorgia31405-
Pillar Clinical ResearchChicagoIllinois60641-
Uptown Research InstituteChicagoIllinois60640-
CBH HealthGaithersburgMaryland20877-
Precise Clinical ResearchFlowoodMississippi39232-
Arch Clinical TrialsSt LouisMissouri63141-
Hassman Research InstituteMarltonNew Jersey08053-
RBAStaten IslandNew York10329-
Midwest Clinical Research CenterDaytonOhio45417-
NBCRNorth CantonOhio44720-
Community Clinical Research, Inc.AustinTexas78754-
InSite Clinical Research, LLCDeSotoTexas75115-
Pillar Clinical Research, LLCRichardsonTexas75080-

Find similar trials in Bentonville, AR

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
Pillar Clinical Research, LLC· Bentonville, ARWIRG· Little Rock, ARWRN· Rogers, ARAdvanced Research Center, Inc.· Anaheim, CACIT LA· Bellflower, CAProScience Research Group· Culver City, CA

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