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Psychomotor Agitation clinical trials

View clinical trials related to Psychomotor Agitation.

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NCT ID: NCT05665088 Terminated - Dementia Clinical Trials

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

Start date: December 14, 2022
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT05276830 Terminated - Dementia Clinical Trials

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

Start date: February 8, 2022
Phase: Phase 2
Study type: Interventional

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 associated with all forms of dementia (i.e., probably Alzheimer's Disease, vascular dementia; mixed; frontotemporal dementia) excluding Parkinson's-Related Dementia and Lewy Body Dementia.

NCT ID: NCT05163717 Terminated - Clinical trials for Agitation in Adolescents and Young Adults With ASD

INP105 Proof-of-concept Study for the Acute Treatment of Agitation in Adolescents and Young Adults With ASD

CALM 201
Start date: June 23, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2a, proof-of concept, 2-way, 2-period crossover, double-blind study to evaluate the safety and efficacy of INP105 as an acute treatment versus placebo in adolescents and young adults with autism spectrum disorder (ASD) experiencing agitation. Approximately 32 ASD patients who are currently being treated for agitation/aggression at several inpatient units specializing in behavioral treatment will be enrolled. INP105 is a novel combination product that sprays a powder formulation of olanzapine to the upper nasal space. An earlier formulation showed a similar extent, but faster rate of absorption compared to the approved intramuscular product. In this study, 5 mg of olanzapine or placebo will be delivered nasally by this combination product to moderately or severely agitated participants. Participants will undergo several screening assessments, including observation session(s) of episode(s) of agitation resulting from a frustration task (eg, a non-preferred activity). At least one observation session must result in a documented moderate to severe agitation episode prior to the participant being eligible to enroll in the study and be randomized to treatment. The study will be conducted in 2 phases. A pilot phase will initially enroll at least 6 participants, who will receive both 5 mg INP105 (5 mg olanzapine) and placebo in random order, in the same crossover design as later participants. Participants will be dosed during a documented moderate to severe episode of agitation. Once 6 participants have completed both dosing periods and have at least 48 hours of post-dose safety data collected, a safety and preliminary efficacy analysis will be performed by an independent unblinded statistical group, and a summary report forwarded to a sponsor-led Data and Safety Review Committee (DSRC), who will remain blinded. Enrollment will be paused during the DSRC pilot phase safety and preliminary efficacy results review. Absent any concerning safety signals, the second phase will enroll all remaining participants. The DSRC may suggest revisions to the protocol, and the protocol amended and approved as necessary, prior to further participants being enrolled.

NCT ID: NCT04610827 Terminated - Sleep Disorder Clinical Trials

Oral Iron Frequency for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder

Start date: November 16, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this research study is to see if the level of serum ferritin differs based on how often oral iron (in the form of ferrous sulfate) is given to children with restless leg syndrome/periodic limb movement disorder.

NCT ID: NCT03992196 Terminated - Clinical trials for Restless Legs Syndrome

A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome

Start date: December 3, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety, tolerability and the long-term efficacy of rotigotine treatment in adolescents with idiopathic Restless Legs Syndrome (RLS).

NCT ID: NCT03899506 Terminated - Clinical trials for Agitation,Psychomotor

Olanzapine Versus Midazolam for Agitation

OvM
Start date: June 18, 2018
Phase:
Study type: Observational

The goal of this research investigation is to conduct a prospective observation of the comparative efficacy of midazolam versus olanzapine for the treatment of acute undifferentiated agitation in the emergency department.

NCT ID: NCT03852771 Terminated - Clinical trials for Restless Legs Syndrome

REST Study (CompRESsion Therapy for RLS)

REST
Start date: March 12, 2019
Phase: N/A
Study type: Interventional

This study in patients with restless leg syndrome (RLS) will evaluate the use of Cirvo™ therapy for the treatment of this disorder when applied to both legs.

NCT ID: NCT03817554 Terminated - Clinical trials for Restless Legs Syndrome

Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients

Start date: July 1, 2019
Phase: Phase 4
Study type: Interventional

A randomized, double-blind controlled Study from a single center to evaluate the effect and safety of pramipexole on peritoneal dialysis patients with restless legs syndrome

NCT ID: NCT03728933 Terminated - Clinical trials for Restless Legs Syndrome

A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause

Start date: December 20, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy of rotigotine against placebo in adolescent subjects with idiopathic Restless Legs Syndrome (RLS) over a 12-week maintenance period and to investigate the safety and tolerability of rotigotine in adolescent subjects with idiopathic RLS.

NCT ID: NCT03708237 Terminated - Clinical trials for End Stage Renal Disease

Effectiveness of Ropinirole and Gabapentin for the Treatment of RLS in Patients on Maintenance HD

Start date: February 19, 2019
Phase: Phase 2
Study type: Interventional

Restless legs syndrome (RLS) is a neurologic disorder characterized by 1) an urge to move the legs, 2) uncomfortable sensations in the legs, 3) symptoms that are often worse the evening or when at rest , and 4) may be temporarily relieved by physical activity. The overall prevalence of RLS in the general population is estimated to be around 10%, however, it is significantly in the end stage kidney disease (ESKD) population is significantly higher (approximately 30%). Studies have shown that RLS has a substantial negative impact on both the physical and the mental health dimensions of quality of life (QOL), such as depression, anxiety, pain, fatigue and sleep disorder. While non-pharmacological treatments should be considered for all patients, pharmacological management of RLS is indicated when the affects patient's sleep or quality of life. Gabapentin and dopamine agonists such as ropinirole are usually the first choices in treating RSL. Although these medications are also used in patients with renal impairment, few studies provide treatment data for the hemodialysis population. Treatment recommendations for this population are largely based on data obtained in the general population. This study aims to evaluate effectiveness of ropinirole and gabapentin for the treatment of restless legs syndrome in patients on maintenance hemodialysis.