Clinical trials: Dexmedetomidine
Bipolar Disorder, Schizophrenia
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
- Conditions
- Bipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder
- Trial name
- NCT06041646
- Testing
- Sublingual film containing Igalmi
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- BioXcel Therapeutics Inc
Agitation, Schizophrenia
Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia
This is a two-stage adaptive Phase Ib trial design, that will identify two doses (lowest dose with clinical benefit and highest safe dose) in a first stage and better evaluate safety, tolerability and variability of effect in the…
- Trial name
- NCT04010305
- Testing
- Sublingual film containing BXCL501 (Dexmedetomidine)
- Where
- 12 sites in United States
- Volunteers
- 135 people
- Sponsor
- BioXcel Therapeutics 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
Sedation
A Study to Learn About the Study Medicine - Precedex in Children From Japan.
The purpose of this study is to look at the safety of Precedex when it was used to calm children at procedures or tests under actual medical practice in Japan.
- Trial name
- NCT06085573
- Testing
- Dexmedetomidine Hydrochloride
- Where
- Japan
- Volunteers
- 111 people
- Sponsor
- Pfizer
Pain, Postoperative
Evaluating Efficacy of the Dexmedetomidine Transdermal System for Postoperative Analgesia Following Abdominoplasty
The primary objective of this study is to evaluate the analgesic efficacy of Dexmedetomidine Transdermal System (DMTS), compared with placebo, in participants following abdominoplasty.
- Trial name
- NCT04242407
- Testing
- DMTS
- Where
- 4 sites in United States
- Volunteers
- 164 people
- Sponsor
- Teikoku Pharma USA, Inc.
Sedation
Long-term Clinical Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects
Evaluate efficacy and safety of dexmedetomidine long term administration in ICU patients who require more than 24 hours sedation.
- Trial name
- NCT00526760
- Testing
- Dexmedetomidine
- Where
- 10 sites in Japan
- Volunteers
- 80 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Alzheimer Disease
Pharmacological Enhancement of Glymphatic Function in Humans
Alzheimer's disease is linked in part to the buildup of harmful proteins in the brain, including amyloid and tau. Most current treatments aim to remove these proteins directly.
- Trial name
- NCT07432997
- Testing
- Dexmedetomidine, Dexmedetomidine and Midodrine
- Where
- 2 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Applied Cognition
Endoscopic Sinus Surgery
The Effect of Dexmedetomidine, Melatonin and Pregabalin
Various drugs have been used for the purpose: nitroglycerine, sodium nitroprusside, propofol, beta blockers, calcium channel blockers, higher concentrations of inhalational anesthetics etc.
- Trial name
- NCT05829148
- Testing
- Dexmedetomidine, Melatonin, Pregabalin
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Egymedicalpedia
ICU Sedation
Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit
To evaluate the efficacy, safety, and pharmacokinetics of dexmedetomidine given as continuous IV infusion in pediatric subjects [≥ 45 weeks CGA (corrected gestational age) to <17 years old] requiring sedation under intensive care…
- Trial name
- NCT02757625
- Testing
- Dexmedetomidine hydrochloride
- Where
- 12 sites in Japan
- Volunteers
- 63 people
- Sponsor
- Pfizer
Preoperative Sedation
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Adults
The study is being conducted to evaluate the efficacy and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in adults.
- Trial name
- NCT04383418
- Testing
- dexmedetomidine hydrochloride nasal spray, dexmedetomidine hydrochloride nasal spray blank preparation
- Where
- China
- Volunteers
- 309 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Sedation
Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading…
- Trial name
- NCT01159262
- Testing
- Midazolam, Fentanyl/Morphine, Dexmedetomidine
- Where
- 18 sites in United States, Guatemala
- Volunteers
- 36 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Preoperative Sedation of Children
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children.
- Trial name
- NCT05111431
- Testing
- Dexmedetomidine Hydrochloride Nasal Spray, Dexmedetomidine hydrochloride nasal spray blank preparation
- Where
- China
- Volunteers
- 159 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Healthy Subjects
A Repeat Dose Study of the Dexmedetomidine Transdermal System in Healthy Subjects
This Phase 1, 16-day Repeat dose study will evaluate the safety of a Dexmedetomidine Transdermal System (DMTS) skin system in healthy adults Subjects.
- Trial name
- NCT07818330
- Testing
- Dexmedetomidine Transdermal System (DMTS)
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Teikoku Pharma USA, Inc.
Agitation
Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type
The primary objective of this study is to evaluate the efficacy of DMTS on frequency and severity of agitation associated with dementia of the Alzheimer's type, compared with placebo.
- Trial name
- NCT06052254
- Testing
- 12 cm2 - 2 Active DMTS Patches
- Where
- 8 sites in United States
- Volunteers
- 150 people
- Sponsor
- Teikoku Pharma USA, Inc.
Bipolar I Disorder, Bipolar II Disorder
Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder
This open-label study will utilize treatment with BXCL501 in order to assess the suitability of patient-and lay informant-assessed outcome measures for evaluation of severity of psychomotor agitation episodes in patients with…
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder
- Trial name
- NCT07116694
- Testing
- BXCL501 Sublingual Film
- Where
- 5 sites in United States
- Volunteers
- 33 people
- Sponsor
- BioXcel Therapeutics Inc
Critical Illness
Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients
The purpose of this study is to determine whether the use of different sedatives affect the weaning process from mechanical ventilation in intensive care patients.
- Trial name
- NICEWEAN (NCT01707680)
- Testing
- SOC
- Where
- 3 sites in Sweden
- Volunteers
- 155 people
- Sponsor
- Orion Corporation, Orion Pharma
Intubated and Mechanically Ventilated Pediatric Subjects
Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects
The objective of this study is to characterize the pharmacokinetic and pharmacodynamic profile of dexmedetomidine administered as an intravenous loading dose followed by a continuous intravenous infusion in pediatric subjects…
- Trial name
- NCT00652028
- Testing
- Dexmedetomidine, midazolam; fentanyl
- Where
- 9 sites in United States, Guatemala
- Volunteers
- 69 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Sedation
Precedex Special Investigation (in Pediatric Patients)
Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.
- Trial name
- NCT04040439
- Testing
- Dexmedetomidine Hydrochloride
- Where
- Japan
- Volunteers
- 111 people
- Sponsor
- Pfizer
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
Pain
Evaluation of DEX-IN During Outpatient Procedures
The primary objective of this study is to evaluate the analgesic efficacy of DEX-IN compared with placebo and active control (fentanyl), in subjects undergoing painful outpatient and office based procedures.
- Trial name
- NCT03348423
- Testing
- DEX-IN, Fentanyl
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Baudax Bio