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Showing 1–24 of 31 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Agitation Associated With Clear all
Recruiting Phase 2Phase 3 Interventional

Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia

NCT07284472
View directory record Official record
Conditions
Agitation Associated With Alzheimer's Disease Dementia
Interventions
EXV-802, Placebo, EXV-801
Drug
Lead sponsor
Exciva GmbH
Industry
Eligibility
55 Years to 90 Years
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
9
States / cities
Murrieta, California • Indianapolis, Indiana • Flowood, Mississippi + 6 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2026 · Synced Sep 13, 2026, 10:59 AM EDT
Completed Phase 3 Interventional Results available

Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance

NCT00991276
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
pregabalin, placebo, pramipexole
Drug
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Industry
Eligibility
18 Years and older
Enrollment
85 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
41
States / cities
Jasper, Alabama • Phoenix, Arizona • Tucson, Arizona + 35 more
Source: ClinicalTrials.gov public record
Updated Feb 14, 2021 · Synced Sep 13, 2026, 10:59 AM EDT
Terminated Phase 3 Interventional

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)

NCT05665088
View directory record Official record
Conditions
Agitation, Dementia
Interventions
BXCL501, Matching Placebo
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
7
States / cities
Los Alamitos, California • Daytona Beach, Florida • Maitland, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated Dec 10, 2023 · Synced Sep 13, 2026, 10:59 AM EDT
Completed Phase 3 Interventional Results available

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)

NCT05271552
View directory record Official record
Conditions
Agitation, Dementia
Interventions
BXCL501, Matching Placebo
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
151 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
11
States / cities
Phoenix, Arizona • Long Beach, California • Daytona Beach, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 13, 2026, 10:59 AM EDT
Completed Phase 3 Interventional Results available

A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation

NCT01862640
View directory record Official record
Conditions
Agitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases
Interventions
Brexpiprazole, OPC-34712, Placebo Oral Tablet
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
55 Years to 90 Years
Enrollment
433 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
37
States / cities
Tuscaloosa, Alabama • Phoenix, Arizona • Bellflower, California + 25 more
Source: ClinicalTrials.gov public record
Updated Dec 30, 2020 · Synced Sep 13, 2026, 10:59 AM EDT
Completed Phase 3 Interventional

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)

NCT05658510
View directory record Official record
Conditions
Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
Interventions
BXCL501, Matching Placebo
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 75 Years
Enrollment
452 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
24
States / cities
Bellflower, California • Cerritos, California • Culver City, California + 19 more
Source: ClinicalTrials.gov public record
Updated Aug 6, 2026 · Synced Sep 13, 2026, 10:59 AM EDT
Completed Phase 3 Interventional Results available

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia

NCT04268303
View directory record Official record
Conditions
Agitation, Schizophrenia, Schizo Affective Disorder, Schizoaffective Disorder, Schizophreniform Disorders
Interventions
Sublingual film containing dexmedetomidine (BXCL501), Placebo Film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 75 Years
Enrollment
380 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
15
States / cities
Little Rock, Arkansas • Cerritos, California • Culver City, California + 12 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 13, 2026, 10:59 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease

NCT06546995
View directory record Official record
Conditions
Alzheimer's Disease, Healthy Elderly
Interventions
NMRA-323511, Placebo
Drug
Lead sponsor
Neumora Therapeutics, Inc.
Industry
Eligibility
55 Years to 90 Years
Enrollment
87 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2025
U.S. locations
26
States / cities
Chandler, Arizona • Tempe, Arizona • Costa Mesa, California + 21 more
Source: ClinicalTrials.gov public record
Updated May 21, 2026 · Synced Sep 13, 2026, 10:59 AM EDT
Recruiting Not applicable Interventional Accepts healthy volunteers

Virtual Reality to Reduce Anxiety, Agitation and Delirium in Critically Ill Patients

NCT07649876
View directory record Official record
Conditions
Delirium in the Intensive Care Unit, Sleep Quality in Adult ICU Patients, Agitation Associated With Critical Illness, Anxiety Acute
Interventions
Virtual reality (VR) therapy
Behavioral
Lead sponsor
Milton S. Hershey Medical Center
Other
Eligibility
Not listed
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026
U.S. locations
1
States / cities
Hershey, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jun 21, 2026 · Synced Sep 13, 2026, 10:59 AM EDT
Completed Phase 3 Interventional Results available

Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

NCT01922258
View directory record Official record
Conditions
Agitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases
Interventions
Brexpiprazole, OPC-34712
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
55 Years to 90 Years
Enrollment
270 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
28
States / cities
Imperial, California • Lakewood, California • Long Beach, California + 21 more
Source: ClinicalTrials.gov public record
Updated Nov 19, 2020 · Synced Sep 13, 2026, 10:59 AM EDT
Recruiting Phase 2 Interventional

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia

NCT06651567
View directory record Official record
Conditions
Agitation Associated With Alzheimer's Dementia
Interventions
ITI-1284, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
55 Years and older
Enrollment
320 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
31
States / cities
Anaheim, California • Costa Mesa, California • Garden Grove, California + 18 more
Source: ClinicalTrials.gov public record
Updated Aug 25, 2026 · Synced Sep 13, 2026, 10:59 AM EDT
Recruiting Phase 3 Interventional

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

NCT06937229
View directory record Official record
Conditions
Alzheimer Disease, Agitation
Interventions
KarXT, KarX-EC
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
55 Years to 90 Years
Enrollment
650 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
46
States / cities
Chandler, Arizona • Scottsdale, Arizona • Anaheim, California + 40 more
Source: ClinicalTrials.gov public record
Updated Aug 18, 2026 · Synced Sep 13, 2026, 10:59 AM EDT
Completed Phase 3 Interventional Results available

A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type

NCT03548584
View directory record Official record
Conditions
Agitation Associated With Alzheimer's Dementia, Alzheimer Dementia
Interventions
Brexpiprazole, Placebo
Drug · Other
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
55 Years to 90 Years
Enrollment
345 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Sep 17, 2023 · Synced Sep 13, 2026, 10:59 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia

NCT04251910
View directory record Official record
Conditions
Agitation,Psychomotor, Dementia
Interventions
Sublingual film containing Dexmedetomidine, Sublingual Placebo Film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
5
States / cities
Homestead, Florida • Miami Lakes, Florida • Springfield, Massachusetts + 2 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 13, 2026, 10:59 AM EDT
Completed Phase 3 Interventional Results available

A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

NCT03594123
View directory record Official record
Conditions
Alzheimer's Disease
Interventions
Brexpiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
55 Years to 91 Years
Enrollment
259 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Nov 13, 2023 · Synced Sep 13, 2026, 10:59 AM EDT
Completed No phase listed Observational

Neuronal Ceroid Lipofuscinosis and Associated Sleep Abnormalities

NCT01966757
View directory record Official record
Conditions
Neuronal Ceroid Lipofuscinosis, Batten's Disease
Interventions
Not listed
Lead sponsor
Nationwide Children's Hospital
Other
Eligibility
Not listed
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Jul 25, 2016 · Synced Sep 13, 2026, 10:59 AM EDT
Not listed Phase 4 Interventional

Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome

NCT02424695
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
Gabapentin Enacarbil (GEn), Placebo
Drug
Lead sponsor
Cleveland Sleep Research Center
Other
Eligibility
18 Years to 65 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
1
States / cities
Middleburg Heights, Ohio
Source: ClinicalTrials.gov public record
Updated Apr 22, 2015 · Synced Sep 13, 2026, 10:59 AM EDT
Completed Phase 3 Interventional Results available

Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder

NCT04276883
View directory record Official record
Conditions
Agitation Associated With Bipolar Disorder, Agitation,Psychomotor, Bipolar Disorder
Interventions
Sublingual film containing Dexmedetomidine (BXCL501), Placebo Film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 75 Years
Enrollment
380 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
15
States / cities
Little Rock, Arkansas • Cerritos, California • Culver City, California + 12 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 13, 2026, 10:59 AM EDT
Completed Phase 3 Interventional Results available

Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance

NCT00748098
View directory record Official record
Conditions
Restless Legs Syndrome, Restless Legs Syndrome (RLS)
Interventions
GSK1838262 Extended Release Tablets, Placebo
Drug
Lead sponsor
XenoPort, Inc.
Industry
Eligibility
18 Years and older
Enrollment
136 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
24
States / cities
Jasper, Alabama • San Diego, California • Hallandale, Florida + 20 more
Source: ClinicalTrials.gov public record
Updated Jul 21, 2013 · Synced Sep 13, 2026, 10:59 AM EDT
Completed Phase 1 Interventional

Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia

NCT04010305
View directory record Official record
Conditions
Agitation, Schizophrenia
Interventions
Sublingual film containing BXCL501 (Dexmedetomidine), Placebo film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 65 Years
Enrollment
135 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
12
States / cities
Little Rock, Arkansas • Cerritos, California • Lemon Grove, California + 9 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 13, 2026, 10:59 AM EDT
Recruiting Phase 2 Interventional

Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type

NCT06052254
View directory record Official record
Conditions
Agitation
Interventions
12 cm2 - 2 Active DMTS Patches, 6 cm2 - 1 Active and 1 Placebo DMTS Patches, Placebo - 2 Placebo DMTS Patches
Drug
Lead sponsor
Teikoku Pharma USA, Inc.
Industry
Eligibility
Not listed
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
8
States / cities
Daytona Beach, Florida • Delray Beach, Florida • Miami, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated Jul 23, 2026 · Synced Sep 13, 2026, 10:59 AM EDT
Terminated Phase 2 Interventional Results available

An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia

NCT05276830
View directory record Official record
Conditions
Agitation, Dementia
Interventions
BXCL501, Placebo film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022
U.S. locations
3
States / cities
North Miami, Florida • Springfield, Massachusetts • Toms River, New Jersey
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 13, 2026, 10:59 AM EDT
Suspended No phase listed Observational

Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder

NCT03513549
View directory record Official record
Conditions
Agitation,Psychomotor
Interventions
Loxapine 10 MG
Drug
Lead sponsor
Alexza Pharmaceuticals, Inc.
Other
Eligibility
18 Years and older
Enrollment
10,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2027
U.S. locations
1
States / cities
Raleigh, North Carolina
Source: ClinicalTrials.gov public record
Updated Oct 20, 2025 · Synced Sep 13, 2026, 10:59 AM EDT
Recruiting Phase 3 Interventional

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)

NCT07011732
View directory record Official record
Conditions
Alzheimer Disease
Interventions
Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, Placebo
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
55 Years to 90 Years
Enrollment
426 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
39
States / cities
Scottsdale, Arizona • Anaheim, California • La Jolla, California + 31 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 13, 2026, 10:59 AM EDT