Clinical trials: Neurobehavioral Manifestation
Analgesia
Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures
This is a prospective non-randomized, open-label, single dose (and a second dose if needed), PK study in 25 children age 1-17 years.
- Trial name
- NCT04897750
- Testing
- CT001
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Cessatech A/S
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
The purpose of this clinical investigation is to evaluate the clinical performance, safety, and clinical benefit of the BrainProtect System in reducing early postoperative neurological complications in adult participants…
- Conditions
- Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction, Postoperative Delirium
- Trial name
- BrainProtect (NCT07872982)
- Testing
- BrainProtect System, Standard perioperative management
- Where
- 4 sites in United States, Austria and 2 more
- Volunteers
- 304 people
- Sponsor
- Scienceforbrain, UAB
Alzheimer Disease
A Study of the Safety and Effectiveness of Galantamine Hydrobromide in Patients With Alzheimer's Disease
The purpose of this study is to evaluate the safety and effectiveness of galantamine hydrobromide in patients with Alzheimer's disease who have not received or have not responded to treatment with medication similar to…
- Trial name
- NCT00297362
- Testing
- Galantamine hydrobromide
- Volunteers
- 344 people
- Sponsor
- Janssen Cilag Pharmaceutica S.A.C.I., Greece
Brain Death
Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multi-modality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury
This is the proof of concept study with multi-modality approach (using intra-thecal bioactive peptides, stem cells, laser and transcranial IV laser and Median Nerve stimulation as adjuvants) in cases of brain death due to…
- Trial name
- NCT02742857
- Testing
- BQ-A Peptide Extract, Mesenchymal Stem Cells, Transcranial Laser Therapy
- Where
- India
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Bioquark Inc.
Bipolar Disorder
Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
The purpose of this study is to assess the safety and tolerability of ziprasidone during a long-term open label study in children and adolescents (ages 10-17) with Bipolar I Disorder (Manic or Mixed).
- Trial name
- NCT01124877
- Testing
- ziprasidone oral capsules
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Pyruvate Dehydrogenase Complex Deficiency
Trial of Dichloroacetate in Pyruvate Dehydrogenase Complex Deficiency:
The objective of this research study is to conduct a pivotal phase 3 trial of treatment with the investigational drug dichloroacetate (DCA) in young children with deficiency of the pyruvate dehydrogenase complex (PDC).
- Trial name
- DCA/PDCD (NCT02616484)
- Testing
- Dichloroacetate (DCA), Genotype
- Where
- 10 sites in United States
- Volunteers
- 34 people
- Sponsor
- Saol Therapeutics Inc
Hypothalamic Obesity, Prader-Willi Syndrome
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
The purpose of this study is to evaluate the safety, tolerability, and PK of RM-718 in healthy subjects with obesity and in patients with MC4R Pathway Impairment
- Conditions
- Hypothalamic Obesity, Prader-Willi Syndrome, PWS
- Trial name
- NCT06239116
- Testing
- Part C: RM-718, Part D: RM-718
- Where
- 7 sites in United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Multiple Sclerosis
Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms
The purpose of this pilot study is to evaluate, by means of a specific cognitive test battery (Brief Repeatable Battery and Delis-Kaplan Executive Function System scale), the slowing/reduction of cognitive dysfunction progression…
- Trial name
- Cognition (NCT01333501)
- Testing
- Fingolimod, Interferon beta 1b
- Where
- 26 sites in Germany, Italy
- Volunteers
- 151 people
- Sponsor
- Novartis Pharmaceuticals
Mucopolysaccharidosis Type II, Metabolic Diseases
A Study of the Tolerance, Safety, and Pharmacokinetics of GNR-055 in Healthy Volunteers
It is a phase I open-label single-dose, dose-escalation cohort study to evaluate of the tolerance, safety, and pharmacokinetics of GNR-055 in healthy volunteers
- Trial name
- NCT06475404
- Testing
- verenafusp alfa 6 mg/kg, verenafusp alfa 9 mg/kg, verenafusp alfa 12 mg/kg
- Where
- Russia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
Acute Agitation
Safety and Tolerability of INP105 (Olanzapine by I231 POD® Device) Nasal Spray in Healthy Volunteers - SNAP 101
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of INP105, which is an investigational drug-device combination product comprised of the drug component OLZ administered by a…
- Trial name
- SNAP101 (NCT03624322)
- Testing
- Zyprexa IM, Zydis, INP105
- Where
- Australia
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Impel Pharmaceuticals
Pain
A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.
The purpose of this study is to compare the effectiveness and safety of sustained- release hydromorphone, formulated to release slowly over time, taken once daily, and controlled- release oxycodone taken twice daily, in patients…
- Trial name
- NCT00261495
- Testing
- OROS hydromorphone HCl, Oxycodone
- Where
- 52 sites in Czechia, Denmark and 8 more
- Volunteers
- 504 people
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
Pain Control
To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Controlled-Release Tablets 600 mg in Comparison to the Reference Standard Ibuprofen Tablets in Normal Healthy Volunteers
To evaluate the food effect of Ibuprofen CR Tablets 600 mg (IBUCR), and its bioavailability comparison versus 3 doses of the reference arms including Advil® Ibuprofen Tablets 200 mg (IBUAdv) and Motrin® IB Ibuprofen Tablets 200…
- Trial name
- NCT03418805
- Testing
- Advil Ibuprofen table 200 mg, Motrin IB Ibuprofen Tablets 200 mg, Ibuprofen CR Tablets 600 mg
- Where
- Taiwan
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Overseas Pharmaceuticals, Ltd.
Down Syndrome (Trisomy 21)
AEF0217 in Participants With Down Syndrome
The goal of this clinical trial is to identify if AEF0217 show an improvement in adaptive behaviors (daily life activities) in adults and older adolescents with Down Syndrome. It will also learn about the safety of AEF0217.
- Trial name
- NCT07334912
- Testing
- AEF0217 100 µg, AEF0217 300 µg
- Where
- 10 sites in France, Italy and 1 more
- Volunteers
- 188 people
- Sponsor
- Aelis Farma
Developmental Delay, Skeletal Abnormalities
Biomarker for Sly Disease (MPS VII) (BioSly)
Development of a new MS-based biomarker for the early and sensitive diagnosis of Sly disease from blood (plasma)
- Conditions
- Developmental Delay, Skeletal Abnormalities, Hepatomegaly, Splenomegaly
- Trial name
- BioSly (NCT02298699)
- Where
- 5 sites in Egypt, Germany and 2 more
- Sponsor
- CENTOGENE GmbH Rostock
Healthy Volunteers
Safety, Tolerability and Pharmacokinetics of Benfo-Oxythiamine (B-OT) in Healthy Volunteers
The goal of this clinical trial was to learn about the safety and tolerability of an investigational drug called Benfo-oxythiamine (B-OT) in healthy male volunteers.
- Trial name
- BOOST (NCT07450833)
- Testing
- Benfo-oxythiamine
- Where
- Bulgaria
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Benfovir AG
Mucopolysaccharidosis Type II, Metabolic Diseases
A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II
This is phase 2/3 study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of the investigational product GNR-055 in MPS II (Hunter syndrome) patients of different age groups.
- Trial name
- NCT05208281
- Testing
- GNR-055 1.0-2.0-3.0 mg/kg, GNR-055 2.0 mg/kg, GNR-055 3.0 mg/kg
- Where
- 5 sites in Russia
- Volunteers
- 32 people
- Sponsor
- AO GENERIUM
Mucopolysaccharidosis (MPS)
Mucopolysaccharidosis (MPS) I, II, and VI Screening in a High-Risk Population With Previous Surgical Repair or Presence of Inguinal and/or Umbilical Hernia in Combination With Pediatric ENT Surgery (The HATT Project)
Mucopolysaccharidosis (MPS) type II (MPS II; Hunter syndrome) is a rare, X-linked disease caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase (I2S) and occurs almost exclusively in boys, with an incidence of…
- Trial name
- NCT02095015
- Where
- 14 sites in United States, Canada and 5 more
- Volunteers
- 159 people
- Sponsor
- Shire
Low Back Pain, Radicular Syndrome
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
This pilot randomized controlled trial aims to compare the clinical effectiveness of advanced high-intensity physical therapy modalities with conventional physical therapy in patients suffering from musculoskeletal disorders.
- Conditions
- Low Back Pain, Radicular Syndrome, Sacroiliac Joint Dysfunction, Shoulder Impingement Syndrome
- Trial name
- NCT07903142
- Testing
- Repetitive Peripheral Magnetic Stimulation (rPMS), High-Intensity Laser Therapy (HIL), Extracorporeal Shockwave Therapy (ESWT)
- Where
- Czechia
- Volunteers
- 60 people
- Sponsor
- BTL Industries Ltd.
Mucopolysaccharidosis II
Long-term Follow-Up for RGX-121
RGX-121-5101 is an observational long-term follow-up study to the RGX-121-101 or RGX-121-1102 studies where participants received RGX-121, a gene therapy intended to deliver a functional copy of the iduronate-2-sulfatase gene…
- Trial name
- NCT04597385
- Testing
- Long-term Follow-Up
- Where
- 4 sites in United States, Brazil
- Volunteers
- 27 people
- Sponsor
- REGENXBIO Inc.
Cognitive Dysfunction, Memory Disorders
A Study of Retinal Imaging to Detect Abnormal Protein Deposits Associated With Alzheimer's Disease
The purpose of this study is to test the use of a screening tool to detect changes in the eye that are associated with Alzheimer's disease in adult participants with memory issues.
- Trial name
- NCT07254234
- Testing
- Retinal scan, Blood test
- Where
- 3 sites in United Arab Emirates
- Volunteers
- 200 people
- Sponsor
- Eli Lilly and Company