Central Nervous System Diseases Clinical Trial
Official title:
Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age
This Phase II open-label, uncontrolled, multicenter trial is designed to investigate the pharmacokinetic (PK) profile of gadopiclenol in plasma, in pediatric patients aged up to 23 months inclusive (term neonates or preterm infants after the neonatal period), using a population PK approach. Primary objective is to evaluate the PK profile of gadopiclenol in plasma following single intravenous injection of 0.05 mmol/kg body weight (BW) in pediatric population aged up to 23 months (inclusive) scheduled for a contrast-enhanced MRI examination of any body region including central nervous system (CNS).
Three age groups are defined: - Group 1: patients aged 3 to 23 months (inclusive) - Group 2: patients aged 28 days to less than 3 months; - Group 3: patients aged from birth to 27 days (term newborns). At study set-up, the inclusions started with the oldest patients in group 1 and using an age-down staggered approach. The decision to start the inclusions in group 2 was taken by the Trial Safety Review Board based on safety assessment over one-day period after injection of the first 13 patients in group 1. According to the protocol version 4 (amendments 2 & 3), the age-down staggered approach was discontinued to allow the inclusions in Group 3 (patients aged from birth to 27 days), simultaneously to inclusions in group 1 and group 2. The inclusions in the three age groups will be completed in parallel. A total of 3 blood samples per patient will be taken post-injection for PK analysis. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05778279 -
Role of New High Resolution Ultrasonographic Modalities for Diagnosis of Fetal Nervous System Anomalies
|
||
| Completed |
NCT00116337 -
Spinal Cord Stimulation to Restore Cough
|
N/A | |
| Completed |
NCT05080777 -
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
|
N/A | |
| Recruiting |
NCT06010823 -
Safety and Efficacy Evaluation of the Robotic Enhanced Error Training of Upper Limb Function in Post-stroke and Post TBI Participants
|
N/A | |
| Completed |
NCT01915368 -
Determining Optimal Post-Stroke Exercise (DOSE)
|
N/A | |
| Completed |
NCT01211873 -
Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions
|
Phase 3 | |
| Completed |
NCT00395460 -
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients
|
Phase 3 | |
| Terminated |
NCT03270189 -
Effect of the Visual Information Change in Functional Dystonia
|
N/A | |
| Active, not recruiting |
NCT03911388 -
HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors
|
Phase 1 | |
| Recruiting |
NCT05968976 -
Multicentre RCT of Awake Versus Asleep Tractography Based DBS for ET
|
N/A | |
| Not yet recruiting |
NCT05892510 -
Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke
|
Phase 2/Phase 3 | |
| Suspended |
NCT04912115 -
Randomized, Double-Blind, Active Placebo-Controlled Study of Ketamine to Treat Levodopa-Induced Dyskinesia
|
Phase 2 | |
| Completed |
NCT03994822 -
pRESET for Occlusive Stroke Treatment
|
N/A | |
| Completed |
NCT04283253 -
Predictors of Response in Chronic Stroke
|
N/A | |
| Completed |
NCT02684825 -
Detection of Silent Atrial Fibrillation aFter Ischemic StrOke
|
N/A | |
| Completed |
NCT02368223 -
Feasibility of the Portable YouGrabber System
|
N/A | |
| Completed |
NCT05815836 -
Precision Medicine in Stroke
|
||
| Completed |
NCT01445639 -
Dexmedetomidine in Patients After Intracranial Surgery
|
Phase 4 | |
| Completed |
NCT00995215 -
Sub-study to Spinal Cord Stimulation to Restore Cough
|
N/A | |
| Completed |
NCT00780078 -
Clinical Evaluation of Swallowing Disorders as a Predictor of Extubation Failure
|
N/A |