Clinical trials: Agitation
Restless Legs
Intravenous Iron Metabolism in Restless Legs Syndrome
Double-blind, placebo-controlled, entitled: "Intravenous Iron Metabolism in Restless Legs Syndrome
- Trial name
- RLS (NCT00685815)
- Testing
- Ferric Carboxymaltose (FCM)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- American Regent, Inc.
Alzheimer's Disease
Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
The primary purpose of this study is to determine whether ELND005 is effective in treating symptoms of agitation and aggression in patients with Alzheimer's disease
- Trial name
- NCT01735630
- Testing
- ELND005
- Where
- 70 sites in United States, Canada and 2 more
- Volunteers
- 350 people
- Sponsor
- OPKO Health, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with…
- Trial name
- NCT04408755
- Testing
- AVP-786
- Where
- 95 sites in United States, Bulgaria and 9 more
- Volunteers
- 184 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Restless Legs Syndrome
Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS
- Trial name
- NCT02231918
- Testing
- MIRAPEX® - low, MIRAPEX® - medium, MIRAPEX® - high
- Volunteers
- 26 people
- Sponsor
- Boehringer Ingelheim
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.
Idiopathic Restless Legs Syndrome
A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.
The objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS.
- Trial name
- NCT00390689
- Testing
- Pramipexole 0.125 mg tablet, Pramipexole 0.5 mg tablet
- Where
- 34 sites in Japan
- Volunteers
- 154 people
- Sponsor
- Boehringer Ingelheim
Restless Legs Syndrome (RLS)
Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia
Treatment Phase I and II Primary Objective: To evaluate the efficacy and safety of FCM (750 mg dose x 2) for treatment of Restless Legs Syndrome (RLS) in patients with iron-deficiency anemia (IDA).
- Trial name
- NCT02826681
- Testing
- Injectafer® (Ferric Carboxymaltose - FCM)
- Where
- 8 sites in United States
- Volunteers
- 70 people
- Sponsor
- American Regent, Inc.
Restless Legs Syndrome
Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)
The primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome (RLS) in comparison to…
- Trial name
- NCT00472199
- Testing
- Pramipexole
- Where
- 42 sites in Austria, Belgium and 7 more
- Volunteers
- 331 people
- Sponsor
- Boehringer Ingelheim
Restless Legs Syndrome
Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)
To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS)
- Trial name
- NCT00654498
- Testing
- Pramipexole
- Where
- 16 sites in China
- Volunteers
- 306 people
- Sponsor
- Boehringer Ingelheim
Agitation in Dementia, Including Alzheimer's Disease
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
This is a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation in patients with dementia, including…
- Trial name
- NCT02817906
- Testing
- ITI-007
- Where
- 26 sites in United States
- Volunteers
- 177 people
- Sponsor
- Intra-Cellular Therapies, 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, 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
Alzheimer's Disease
A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.
- Trial name
- NCT01766336
- Testing
- Group 1 ELND005, Group 2 ELND005
- Where
- 46 sites in United States, Canada and 2 more
- Volunteers
- 296 people
- Sponsor
- OPKO Health, Inc.
Alzheimer's Disease
Treatment for Aggression and Agitation in Patients With Alzheimer's Disease
The purpose of this study is to determine whether this drug can help symptoms of aggression and agitation in participants with Alzheimer's disease.
- Trial name
- NCT00843518
- Testing
- LY451395
- Where
- 17 sites in United States
- Volunteers
- 132 people
- Sponsor
- Eli Lilly and Company
Agitation in Patients With Dementia of the Alzheimer's Type
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with…
- Trial name
- NCT04464564
- Testing
- AVP-786
- Where
- 106 sites in United States, Belgium and 11 more
- Volunteers
- 241 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Restless Legs Syndrome
Simulated Driving Study in Restless Legs Syndrome
This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS).
- Trial name
- XP083 (NCT01332318)
- Testing
- XP13512, Diphenhydramine
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- XenoPort, Inc.
Agitation and Aggression in Alzheimer's Disease
Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)
To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment
- Trial name
- NCT02992132
- Testing
- Pimavanserin 34 mg, Pimavanserin 20 mg
- Where
- 56 sites in United States, Chile and 3 more
- Volunteers
- 111 people
- Sponsor
- ACADIA Pharmaceuticals Inc.
Schizophrenia
Efficacy and Safety of SEROQUEL Extended Release (XR) in Acute Schizophrenia
The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR) tablets for 3 weeks will improve their agitation when they have acute psychosis.
- Trial name
- NCT00954122
- Testing
- Quetiapine XR (Seroquel XR)
- Where
- 2 sites in Malaysia
- Volunteers
- 35 people
- Sponsor
- AstraZeneca
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
Restless Legs Syndrome
Long-Term Study of Gabapentin Enacarbil (GEn, XP13512) vs. Placebo in Patients With Restless Legs Syndrome.
The primary objective of this trial is to assess the maintenance of efficacy of gabapentin enacarbil (GEn, XP13512) taken once daily in the long-term treatment of patients suffering from Restless Legs Syndrome (RLS).
- Trial name
- NCT00311363
- Testing
- GEn (XP13512)
- Volunteers
- 327 people
- Sponsor
- XenoPort, Inc.