Clinical trials: Disorder, Pediatric
Malnutrition, Child
Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age
Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of age who require parenteral nutrition for at…
- Trial name
- NCT03563222
- Testing
- Smoflipid, Intralipid, 20%
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Fresenius Kabi
Esophageal Atresia, Digestive System Abnormalities
Flourish™ Pediatric Esophageal Atresia
This study is continued evaluation of the safety and probable benefit of the Flourish Pediatric Esophageal Atresia device through the Humanitarian Device Exemption (HDE) pathway.
- Conditions
- Esophageal Atresia, Digestive System Abnormalities, Esophageal Disorders Congenital
- Trial name
- NCT03615495
- Testing
- Flourish Pediatric Esphogeal Atresia device
- Where
- 12 sites in United States, Canada
- Volunteers
- 21 people
- Sponsor
- Cook Research Incorporated
Psoriasis
A Safety and Pharmacokinetics Study of IDP-118 Lotion in Pediatric Participants With Plaque Psoriasis
This study is to evaluate the safety, the systemic exposure, and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-118 lotion in pediatric participants with moderate to severe plaque…
- Trial name
- NCT03988439
- Testing
- IDP-118 Lotion
- Where
- 9 sites in United States, Dominican Republic and 1 more
- Volunteers
- 16 people
- Sponsor
- Bausch Health Americas, Inc.
Congenital Adrenal Hyperplasia
Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due…
- Trial name
- NCT04806451
- Testing
- Crinecerfont
- Where
- 46 sites in United States, Belgium and 8 more
- Volunteers
- 103 people
- Sponsor
- Neurocrine Biosciences
Peanut Allergy
Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Primary objective is to assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a post up-dosing…
- Trial name
- NCT03682770
- Testing
- Dupilumab, AR101
- Where
- 25 sites in United States
- Volunteers
- 148 people
- Sponsor
- Regeneron Pharmaceuticals
Epilepsy
A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment
The purpose of the study is to assess the long-term use of lacosamide oral solution dosed at 2 mg/kg/day to 12 mg/kg/day when administered to pediatric study participants with epilepsy who have completed NCT01964560 (EP0034) or…
- Trial name
- NCT04627285
- Testing
- Lacosamide
- Where
- 15 sites in Georgia, Hungary and 4 more
- Volunteers
- 48 people
- Sponsor
- UCB Biopharma SRL
PIK3CA-related Overgrowth Spectrum (PROS)
Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)
This Phase II, multicenter, open-label study, preceded by a retrospective non-interventional period, is assessing the long-term safety and efficacy of alpelisib in pediatric and adult participants with PIK3CA-related overgrowth…
- Trial name
- EPIK-P3 (NCT04980833)
- Testing
- Alpelisib
- Where
- 6 sites in United States, France and 2 more
- Volunteers
- 41 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients
The purpose of this study is to assess the predictive ability of three asthma risk markers: the ratio of controller medication to total asthma medication, an albuterol only marker, and an oral corticosteroid use marker, as well…
- Trial name
- NCT01346852
- Testing
- Asthma treatment with an asthma-related medication and at least one asthma controller medication
- Volunteers
- 101,437 people
- Sponsor
- GlaxoSmithKline
Growth Disorders
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Slovakia
This is a Slovakian, Multicentre, Observational Study to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of…
- Trial name
- ECOS SVK (NCT01400984)
- Testing
- easypod™
- Where
- Slovakia
- Volunteers
- 92 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Atopic Dermatitis (AD), SCORAD Index (15-25)
In-Use Tolerance Study Under Dermatological and Pediatric Controls of Sunscreen in Children With Atopic Dermatitis
Atopic dermatitis is a chronic skin condition requiring sun protection, yet research on sunscreen effectiveness and skin tolerance in Atopic Dermatitis is limited.
- Trial name
- NCT07194408
- Testing
- Sunscreen RV4620A RP2552
- Where
- Mauritius
- Volunteers
- 22 people
- Sponsor
- Pierre Fabre Dermo Cosmetique
Bipolar Disorder
Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)
This study will investigate the safety and tolerability of a flexible dosing regimen of asenapine for the long-term treatment of manic or mixed episodes associated with bipolar disorder I in children and adolescents who completed…
- Trial name
- ADDRESS-98 (NCT01349907)
- Testing
- Asenapine, Rescue medication
- Volunteers
- 322 people
- Sponsor
- Organon and Co
Epilepsies, Partial
Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures
The study will evaluate the long-term safety and tolerability of pregabalin in pediatric patients, age 1 month through 16 years, with partial onset seizures.
- Trial name
- NCT00448916
- Testing
- Pregabalin
- Where
- 18 sites in United States, Mexico and 1 more
- Volunteers
- 54 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Neuromyelitis Optica Spectrum Disorder
Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
A Phase 2, open-label, multicenter study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of inebilizumab in eligible pediatric participants 2 to < 18 years of age with recently active neuromyelitis optica…
- Trial name
- NCT05549258
- Testing
- Inebilizumab
- Where
- 19 sites in United States, Argentina and 9 more
- Volunteers
- 15 people
- Sponsor
- Amgen
Distal Renal Tubular Acidosis
Study Evaluating Subjects With Distal Renal Tubular Acidosis
This is a phase 3, prospective, multicenter, randomized, double-blinded, placebo-controlled withdrawal study comparing the efficacy of ADV7103 versus placebo in preventing the development of metabolic acidosis in pediatric and…
- Trial name
- NCT03644706
- Testing
- ADV7103
- Where
- 8 sites in United States, Canada
- Volunteers
- 3 people
- Sponsor
- Advicenne Pharma
Congenital Myasthenic Syndrome, CMS
A Study to Assess Efficacy and Safety of Adimanebart in Adult and Pediatric Participants With DOK7-,MUSK-, AGRN-, or LRP4- Congenital Myasthenic Syndromes (CMS)
The purpose of this study is to assess efficacy and safety of adimanebart in participants at least 12 years of age with DOK7-, MUSK-, AGRN-, or LRP4- Congenital Myasthenic Syndromes (CMS).
- Trial name
- CoMetS (NCT07746089)
- Testing
- Adimanebart IV
- Volunteers
- 105 people
- Sponsor
- argenx
Acute Myeloid Leukemia, AML, Childhood
ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML
This research study was planned to focus on a rare type of acute myeloid leukemia (with the subtype CBFA2T3::GLIS2 that overexpresses folate receptor alpha (FRα) (a protein on the surface of leukemia cells)) that has relapsed or…
- Conditions
- Acute Myeloid Leukemia, AML, Childhood, Relapsed Pediatric AML, Refractory Pediatric AML
- Trial name
- Pediatric AML (NCT05622591)
- Testing
- ELU001
- Sponsor
- Elucida Oncology
Cerebral Palsy
PlayGait: A Dynamic Exoskeleton
PlayGait is an investigational dynamic energy storage and return (ESR) lower-limb exoskeleton for young children with cerebral palsy (CP), that stores energy while the child is in the stance phase of walking and returns that…
- Trial name
- NCT05318690
- Testing
- PlayGait, Baseline
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Orthocare Innovations, LLC
Type 1 Diabetes
The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France.
The purpose of the study is to evaluate the efficacy in glycemic control and the impact on the quality of life of patients using the MiniMed™ 780G System for the treatment of Type 1 diabetes, in real life settings in France.
- Trial name
- NCT04308291
- Testing
- MiniMed™ 780G System
- Where
- 32 sites in France
- Volunteers
- 306 people
- Sponsor
- Medtronic MiniMed, Inc.
Myopia
Characterization of the Central and Peripheral Wavefront Aberration Profile in Pediatric Myopic Subjects
This is a 3-visit, single site, observational clinical study to evaluate the characterization of the central and peripheral wavefront aberration profiles in pediatric myopic subjects.
- Trial name
- NCT06075576
- Testing
- Intervention
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Vision Care, Inc.
Dermatitis Atopic
A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis
This is a 2-year, open-label, exploratory study with a 4-week screening period and a 104-week treatment phase designed to investigate dupilumab's long-term effect on skin barrier function as measured by transepidermal water loss…
- Trial name
- PELISTAD-EX2 (NCT05983068)
- Testing
- dupilumab
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 48 people
- Sponsor
- Sanofi
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