Clinical trials: Disorder, Pediatric
Migraine
Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with episodic migraine.
- Trial name
- OASIS(EM) (NCT03836040)
- Testing
- Erenumab Dose 1, Erenumab Dose 2, Erenumab Dose 3
- Where
- 11 sites in United States, Belgium and 2 more
- Volunteers
- 457 people
- Sponsor
- Amgen
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
FLT3-mutated Acute Myeloid Leukemia
A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
This study will evaluate the safety, efficacy and pharmacokinetics of midostaurin in combination with standard chemotherapy in pediatrics patients with newly diagnosed FLT3-mutated Acute Myeloid Leukemia.
- Trial name
- NCT03591510
- Testing
- Midostaurin, Fludarabine, Cytarabine
- Where
- 15 sites in Czechia, Germany and 8 more
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Menorrhagia
Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding
This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female subjects ages 12-16 years with heavy…
- Trial name
- PREA (NCT01190150)
- Testing
- tranexamic acid
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Ferring Pharmaceuticals
Generalized Convulsive Epilepsy
Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures
This study will assess the efficacy, safety, and tolerability of adjunctive treatment with LEV (3,000 mg/day or a target dose of 60 mg/kg/day in children) compared to placebo in reducing PGTC seizures in subjects (4 - 65 years)…
- Trial name
- NCT00160550
- Testing
- Levetiracetam
- Volunteers
- 154 people
- Sponsor
- UCB Pharma
Colitis, Ulcerative
A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with…
- Trial name
- NCT01900574
- Testing
- Golimumab
- Where
- 27 sites in United States, Austria and 8 more
- Volunteers
- 35 people
- Sponsor
- Janssen Research & Development, LLC
Heterozygous Familial Hypercholesterolemia
Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
- Trial name
- HAUSER-RCT (NCT02392559)
- Testing
- Evolocumab
- Where
- 66 sites in United States, Australia and 24 more
- Volunteers
- 158 people
- Sponsor
- Amgen
Iron Deficiency Anemia
Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA
The primary objective of this study is to demonstrate the efficacy and safety of intravenous ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron deficiency anemia.
- Trial name
- NCT03523117
- Testing
- Ferric carboxymaltose, Ferrous Sulfate
- Where
- 16 sites in United States
- Volunteers
- 79 people
- Sponsor
- American Regent, Inc.
Solid Tumors
Study of EZN-2208 Pediatric Patients With Solid Tumors
The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to pediatric patients with Relapsed or Refractory Solid Tumors.
- Trial name
- NCT01295697
- Testing
- EZN-2208
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- Enzon Pharmaceuticals, Inc.
Von Willebrand Disease (VWD)
Post Trial Access Program of TAK-577 for Von Willebrand Disease (VWD)
The post-trial access program allows eligible participants to gain access to unlicensed treatment on compassionate grounds. Recombinant von Willebrand factor (rVWF) also known as TAK-577, is a medicine to help treat Von…
- Trial name
- NCT06173024
- Testing
- TAK-577
- Sponsor
- Takeda
Hearing Loss, Sensorineural
Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
The purpose of this investigation is to demonstrate the safety and effectiveness of MED-EL cochlear implants in children 7 months to 5 years, 11 months of age who fall outside the current FDA-approved candidacy criteria and, yet…
- Trial name
- NCT03900897
- Testing
- MED-EL SYNCHRONY PIN Cochlear Implant, Cochlear Implant
- Where
- 8 sites in United States
- Volunteers
- 247 people
- Sponsor
- Med-El Corporation
Diabetes Mellitus
EtCO2 for Monitoring and Predicting Severity of DKA in Pediatric Emergency, Doha, Qatar.
Metabolic acidosis is one of the important and life-threatening pathophysiological changes in DKA and its monitoring is essential.
- Trial name
- NCT04121572
- Testing
- Nasal cannula capnography
- Where
- Qatar
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Hamad Medical Corporation
Schizophrenia, Schizoaffective Disorder
A Safety and Pharmacokinetic Study of ER OROS Paliperidone in Pediatric Patients With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
The purposes of this study are to characterize the pharmacokinetics of paliperidone after single- and multiple-dose administration of paliperidone ER in children and adolescent patients (>= 10 to <= 17 years of age) with…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
- Trial name
- NCT00796081
- Testing
- ER OROS paliperidone, paliperidone ER
- Volunteers
- 25 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Diabetes Mellitus, Type 1
Accu-Chek® CONNECT at School (CATS) Pediatric Study
This interventional, 6-month post-marketing study is designed to evaluate the change in diabetes-related distress among parents/caregivers of school-age children and adolescents with type 1 diabetes (T1D) who are receiving…
- Trial name
- CATS (NCT02609633)
- Testing
- Accu-Chek® CONNECT DMS, DMS
- Where
- 13 sites in United States
- Volunteers
- 196 people
- Sponsor
- Hoffmann-La Roche
Transfusional Iron Overload, Beta-Thalassemia
Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload
This is an open-label study to assess the pharmacokinetics, safety, efficacy and tolerability of SSP-004184AQ. The study consists of two phases: the pharmacokinetic phase, using a single 16 mg/kg dose of SSP-004184AQ; and the…
- Trial name
- NCT01363908
- Testing
- SPD602
- Where
- 9 sites in United States, Canada and 3 more
- Volunteers
- 30 people
- Sponsor
- Shire
Narcolepsy, Sleep Apnea, Obstructive
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS (obstructive sleep…
- Trial name
- NCT00107848
- Testing
- Modafinil
- Where
- 61 sites in United States, Canada
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Cephalon
Hypertension
Olmesartan Pediatric Pharmacokinetic (PK) Study
Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years
- Trial name
- NCT00151814
- Testing
- Olmesartan medoxomil
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Daiichi Sankyo
Febrile Neutropenia, Neutropenia
Prevention of Febrile Neutropenia by Synbiotics in Pediatric Cancer Patients
Febrile neutropenia (FN) is a major life-threatening treatment complication in cancer patients undergoing intensive chemotherapy. Endogenous flora is considered to be one of the main sources of infections during neutropenia.
- Conditions
- Febrile Neutropenia, Neutropenia, Infection in an Immunocompromised Host, Cancer
- Trial name
- FENSY (NCT02544685)
- Testing
- Probio-Fix Inum, Beneo Synergy 1
- Where
- Slovakia
- Volunteers
- 120 people
- Sponsor
- S&D Pharma SK s.r.o.
Mucopolysaccharidosis II
A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome
This is a multicenter, multiregional, open-label study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme…
- Trial name
- NCT04251026
- Testing
- tividenofusp alfa
- Where
- 7 sites in United States, Canada and 2 more
- Volunteers
- 47 people
- Sponsor
- Denali Therapeutics Inc.
Infections, Human Immunodeficiency Virus and Herpesviridae
Relative Bioavailability Study of a Pediatric Granule Formulation of Dolutegravir
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor currently in Phase 3 clinical trials for the treatment of human immunodeficiency virus (HIV) infection.
- Trial name
- NCT01382238
- Testing
- Dolutegravir 50 mg tablet, Dolutegravir 50 mg oral granules
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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