Clinical trials: Agitation
Opioid Withdrawal
Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal
This Phase 1b/2 inpatient study assessed the safety, pharmacokinetics, and early signs of efficacy of escalating doses of BXCL501 versus placebo following discontinuation of morphine maintenance.
- Trial name
- NCT04470050
- Testing
- Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 225 people
- Sponsor
- BioXcel Therapeutics Inc
Idiopathic Restless Legs Syndrome
Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects
This is a multicenter, open-label trial to assess safety and tolerability of rotigotine in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year in subjects who previously…
- Trial name
- NCT00498108
- Testing
- Rotigotine
- Where
- Germany
- Volunteers
- 341 people
- Sponsor
- UCB Pharma
Restless Legs Syndrome
Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
This is a multi-center, open-label extension trial conducted at the same European sites that participated in trial SP 709 (NCT00243217).
- Trial name
- NCT00498186
- Testing
- Rotigotine
- Where
- 24 sites in Austria, Germany and 1 more
- Volunteers
- 295 people
- Sponsor
- UCB Pharma
Restless Legs Syndrome
12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects
The purpose of this study is to assess efficacy and safety of pregabalin in treating moderate to severe Restless Legs Syndrome in comparison to placebo.
- Trial name
- NCT01061372
- Testing
- pregabalin
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease
A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation
This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor
- Trial name
- ACCORD-2 (NCT04947553)
- Testing
- AXS-05 (dextromethorphan-bupropion)
- Where
- 47 sites in United States, Canada and 1 more
- Volunteers
- 456 people
- Sponsor
- Axsome Therapeutics, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type
Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.
- Trial name
- NCT02446132
- Testing
- AVP-786
- Where
- 227 sites in United States, Bulgaria and 8 more
- Volunteers
- 1,197 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Right-To-Left Shunt
Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
This is a phase 3, multicenter, open-label, blinded, crossover trial in which each participant will undergo a randomized sequence of ASI-02 and agitated saline standard of care (SoC) via a saline contrast transthoracic…
- Trial name
- ENHANCE (NCT06938347)
- Testing
- Agitated Saline SoC, ASI-02
- Where
- 8 sites in United States, Canada
- Volunteers
- 300 people
- Sponsor
- Agitated Solutions, Inc.
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.
Agitation in the Elderly
A Study of BNC210 in Elderly Patients With Agitation
This is a Phase II randomised, double-blind, placebo-controlled study assessing the effects of BNC210 on agitation in hospitalised elderly patients as measured by the Pittsburgh Agitation Scale (PAS).
- Trial name
- NCT03548194
- Testing
- BNC210
- Where
- 5 sites in Australia
- Volunteers
- 38 people
- Sponsor
- Bionomics Limited
Restless Legs Syndrome
Ropinirole Tablets In Young Patients With Restless Legs Syndrome
This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group.
- Trial name
- NCT00140712
- Testing
- Ropinirole Immediate Release
- Where
- 9 sites in United States, Belgium and 1 more
- Volunteers
- 9 people
- Sponsor
- GlaxoSmithKline
Schizophrenia
A Study of Olanzapine in Patients With Schizophrenia
The primary objectives of the study is to confirm if the efficacy of intramuscular injection (IM) olanzapine 10 milligrams (mg) in patients with an exacerbation of schizophrenia with acute psychotic agitation is greater than…
- Trial name
- NCT00970281
- Testing
- Rapid-Acting Intramuscular Olanzapine
- Where
- 11 sites in Japan
- Volunteers
- 91 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.
Restless Legs Syndrome
Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)
The objectives of this Post Marketing Surveillance (PMS) are: Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Syndrome Scale (IRLS) and…
- Trial name
- NCT02248155
- Testing
- Pramipexole
- Volunteers
- 2,644 people
- Sponsor
- Boehringer Ingelheim
Restless Legs Syndrome
XP13512 vs. Placebo in Patients With Restless Legs Syndrome.
The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).
- Trial name
- NCT00365352
- Testing
- XP13512 600MG, XP13512 1200MG
- Volunteers
- 325 people
- Sponsor
- XenoPort, Inc.
Alzheimer's Disease, Healthy Elderly
Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease
This study consists of 2 parts, Part A and Part B. Part A is a single center, randomized, double-blind, placebo-controlled cohort designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of NMRA-323511 among…
- Trial name
- NCT06546995
- Testing
- NMRA-323511
- Where
- 26 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Neumora Therapeutics, Inc.
Anti-Psychotic, Management of Manifestations of Psychotic Disorders
Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride
Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to the RLD.
- Conditions
- Anti-Psychotic, Management of Manifestations of Psychotic Disorders, Treatment of Schizophrenia, Control Nausea and Vomiting
- Trial name
- NCT02943213
- Testing
- Chlorpromazine Hydrochloride
- Where
- South Africa
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
RLS
An Efficacy and Safety Evaluation of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS
The primary objective of the trial is to evaluate the efficacy of HORIZANT 300 mg and 600 mg, compared to placebo, at 12 weeks of treatment, for the treatment of Restless Legs Syndrome (RLS) in adolescents (13 to 17 years of age)…
- Trial name
- RLS (NCT02560766)
- Testing
- HORIZANT 300 mg, HORIZANT 600 mg
- Where
- 12 sites in United States
- Volunteers
- 132 people
- Sponsor
- XenoPort, Inc.
Restless Legs Syndrome
Long-Term Safety Of Ropinirole XR In Patients With Restless Legs Syndrome
The primary objective of this study is to assess the safety and tolerability of ropinirole XR in the long-term treatment (up to 52 weeks)of adults with RLS.
- Trial name
- NCT00355641
- Testing
- Ropinirole Extended Release (XR)
- Where
- 65 sites in United States, Canada
- Volunteers
- 450 people
- Sponsor
- GlaxoSmithKline
Agitation in Patients With Dementia of the Alzheimer's Type
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.
- Trial name
- NCT03393520
- Testing
- AVP-786
- Where
- 211 sites in United States, Australia and 9 more
- Volunteers
- 601 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.