Clinical trials: Agitation Associated With
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 Associated With Dementia of the Alzheimer's Type
Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who require medication, and to investigate the…
- Trial name
- NCT03620981
- Testing
- Brexpiprazole
- Where
- Japan
- Volunteers
- 410 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Restless Legs Syndrome
Clinical Evaluation of Ropinirole IR (Immediate Release) Tablets in Patients Who Are Diagnosed With Symptomatic Restless Legs Syndrome (RLS) Associated With Chronic Kidney Disease (CKD) Managed With Haemodialysis (Including Haemofiltration and Haemodiafiltration)
This is a multicenter, placebo controlled, parallel group, double-blind, randomized comparison study to evaluate the efficacy and safety of ropinirole IR tablets orally administered for 12 weeks in patients with symptomatic…
- Trial name
- NCT00996944
- Testing
- Ropinirole immediate release (IR)
- Where
- 19 sites in Japan
- Volunteers
- 34 people
- Sponsor
- GlaxoSmithKline
Agitation, Dementia
An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia
A randomized, double-blind, placebo-controlled parallel group 3-arm study assessing efficacy, safety, and tolerability of two doses BXCL501 in male and female geriatric residents (65 years and older) with acute agitation…
- Trial name
- NCT05276830
- Testing
- BXCL501
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- BioXcel Therapeutics Inc
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
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.
- Trial name
- NCT00991276
- Testing
- pregabalin, pramipexole
- Where
- 41 sites in United States
- Volunteers
- 85 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Agitation, Schizophrenia
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in schizophrenia.
- Conditions
- Agitation, Schizophrenia, Schizo Affective Disorder, Schizoaffective Disorder
- Trial name
- SERENITY I (NCT04268303)
- Testing
- Sublingual film containing dexmedetomidine (BXCL501)
- Where
- 15 sites in United States
- Volunteers
- 380 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 Disease
Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type
- Conditions
- Agitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder
- Trial name
- NCT01922258
- Testing
- Brexpiprazole, OPC-34712
- Where
- 70 sites in United States, Bulgaria and 7 more
- Volunteers
- 270 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, 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
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.
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 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
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, 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