Clinical trials: Agitation Associated With
Agitation Associated With Dementia of the Alzheimer's Type
Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy…
- Trial name
- NCT03724942
- Testing
- Brexpiprazole
- Where
- Japan
- Volunteers
- 164 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Restless Legs Syndrome, Depression
Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances
The primary objective of this study is to determine the efficacy of pramipexole 0.125 mg to 0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and depressive symptoms, after 12 weeks of treatment
- Trial name
- NCT00356096
- Testing
- pramipexole
- Where
- 54 sites in Finland, France and 7 more
- Volunteers
- 404 people
- Sponsor
- Boehringer Ingelheim
Alzheimer Disease
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)
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.
- Trial name
- NCT07011732
- Testing
- Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule
- Where
- 162 sites in United States, Argentina and 13 more
- Volunteers
- 426 people
- Sponsor
- Bristol-Myers Squibb
Restless Legs Syndrome, Restless Legs Syndrome (RLS)
Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance
The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.
- Trial name
- NCT00748098
- Testing
- GSK1838262 Extended Release Tablets
- Where
- 24 sites in United States
- Volunteers
- 136 people
- Sponsor
- XenoPort, Inc.
Alzheimer's Disease
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
Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type…
- Trial name
- NCT03594123
- Testing
- Brexpiprazole
- Where
- United States
- Volunteers
- 259 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation Associated With Bipolar Disorder, Agitation,Psychomotor
Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder.
- Conditions
- Agitation Associated With Bipolar Disorder, Agitation,Psychomotor, Bipolar Disorder
- Trial name
- SERENITY II (NCT04276883)
- Testing
- Sublingual film containing Dexmedetomidine (BXCL501)
- Where
- 15 sites in United States
- Volunteers
- 380 people
- Sponsor
- BioXcel Therapeutics Inc
Agitation Associated With, Alzheimer's Disease
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
To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.
- Conditions
- Agitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder
- Trial name
- NCT01862640
- Testing
- Brexpiprazole, OPC-34712
- Where
- 85 sites in United States, Croatia and 5 more
- Volunteers
- 433 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation, Dementia
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)
A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed [PRN]), for a maximum of 168 doses within a 12-week treatment period.
- Trial name
- NCT05665088
- Testing
- BXCL501
- Where
- 7 sites in United States
- Volunteers
- 13 people
- Sponsor
- BioXcel Therapeutics Inc
Agitation,Psychomotor, Bipolar I Disorder
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)
In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform…
- Conditions
- Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizophrenia
- Trial name
- NCT05658510
- Testing
- BXCL501
- Where
- 24 sites in United States
- Volunteers
- 452 people
- Sponsor
- BioXcel Therapeutics Inc
Schizophrenia, Schizo-Affective Disorder
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
- Conditions
- Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I
- Trial name
- NCT05025605
- Testing
- BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
- Where
- 5 sites in United States
- Volunteers
- 140 people
- Sponsor
- BioXcel Therapeutics Inc
Agitation,Psychomotor, Dementia
Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia
This is an adaptive Phase 1b/2 trial design. It is randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL-501 dosing in adult (65 years…
- Trial name
- TRANQUILITY (NCT04251910)
- Testing
- Sublingual film containing Dexmedetomidine
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- BioXcel Therapeutics Inc
Agitation Associated With Alzheimer's Dementia, Alzheimer Dementia
A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type
This study compares the efficacy of 2 doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.
- Trial name
- NCT03548584
- Testing
- Brexpiprazole
- Where
- United States
- Volunteers
- 345 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation Associated With Alzheimer's Dementia
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia.
- Trial name
- NCT06651567
- Testing
- ITI-1284
- Where
- 70 sites in United States, Bulgaria and 6 more
- Volunteers
- 320 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Agitation, Dementia
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)
A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed [PRN]), for a maximum of 28 doses within a 12-week treatment period.
- Trial name
- NCT05271552
- Testing
- BXCL501
- Where
- 11 sites in United States
- Volunteers
- 151 people
- Sponsor
- BioXcel Therapeutics Inc