Clinical trials: Pediatric Disease
Acute Otitis Media, AOMT
Dose Ranging Study of OTO-201 in AOMT
Dose Ranging Study of OTO-201 in AOMT
- Trial name
- NCT02719158
- Testing
- 6 mg ciprofloxacin, 12 mg ciprofloxacin
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- Otonomy, Inc.
Hemophilia A
Russian Kogenate Pediatric Study
A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.
- Trial name
- NCT00632814
- Testing
- rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week, rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg), rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)
- Where
- 4 sites in Russia
- Volunteers
- 32 people
- Sponsor
- Bayer
Metabolic Disorders
A Trial of a Single ProHema-CB Product Transplant in Pediatric Patients With Inherited Metabolic Disorders
The purpose of this study is to describe the safety profile of ProHema-CB as part of a single cord blood unit transplant after a myeloablative conditioning regimen in pediatric patients with inherited metabolic disorders.
- Trial name
- PROVIDE (NCT02354443)
- Testing
- ProHema-CB Transplant
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Fate Therapeutics
Bipolar I Disorder
The Young Adult and Pediatric Bipolar Study
To examine the safety and effectiveness of extended-release carbamazepine in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.
- Trial name
- NCT00350857
- Testing
- Extended-Release Carbamazepine
- Where
- 26 sites in United States
- Volunteers
- 161 people
- Sponsor
- Validus Pharmaceuticals
Adenoidal Disorder, Tonsillitis
Study on the Efficacy and Safety of a Device for Post-op Recovery in Pediatric Adenectomy/Adenotonsillectomy.
The objective of this prospective pre-market interventional clinical study is to evaluate the efficacy and safety of the medical device Munatoril® Aerosol Combo in its different modalities of use, through the analysis of clinical…
- Conditions
- Adenoidal Disorder, Tonsillitis, Otorhinolaryngologic Diseases, Nasal Disease
- Trial name
- NCT06478433
- Testing
- Munatoril Aerosol Combo, Iperclenny
- Volunteers
- 90 people
- Sponsor
- Pharmaluce srl
Ventricular Dysfunction, Ventricular Dysfunction, Left
Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.
The purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric.
- Conditions
- Ventricular Dysfunction, Ventricular Dysfunction, Left, Ventricular Dysfunction, Right
- Trial name
- NCT03701997
- Testing
- EXCOR Pediatric
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Berlin Heart, Inc
Epilepsy
A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.
- Trial name
- NCT01964560
- Testing
- Lacosamide
- Where
- 141 sites in United States, Argentina and 33 more
- Volunteers
- 540 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Schizophrenia, Autism
Lurasidone Pediatric Pharmacokinetics Study
This is a Phase 1, open-label, multicenter, single and multiple ascending lurasidone dose study in subjects from 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric…
- Trial name
- NCT01620060
- Testing
- Lurasidone
- Where
- 10 sites in United States
- Volunteers
- 105 people
- Sponsor
- Sumitomo Pharma America, Inc.
Crohn Disease
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.
- Trial name
- NCT05906576
- Testing
- Infliximab
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Acne Vulgaris
A Study of Acne Treatment in Children Ages 9 to 11
A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9 to 11 is safe and efficacious.
- Trial name
- NCT00907335
- Testing
- Retin-A Micro 0.04% facial acne treatment, Vehicle control
- Where
- 12 sites in United States
- Volunteers
- 110 people
- Sponsor
- Bausch Health Americas, Inc.
Cerebral Palsy, Acquired Brain Injury
Proof of Concept of Pediatric and Adolescent EXPLORER V2 Exoskeleton in Children With Neurological and Neuromuscular Disease
The goal of this clinical trial is to analyze the usability and safety of the prototype gait exoskeleton EXPLORE V2 in children with neurological and neuromuscular disease.
- Conditions
- Cerebral Palsy, Acquired Brain Injury, Neuromuscular Diseases in Children
- Trial name
- NCT05914818
- Testing
- EXPLORER V2
- Where
- 5 sites in Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- MarsiBionics
Asthma
FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects
The purpose of this study is to address an Food Drug and Administration (FDA) request to provide safety data in pre-asthmatic patients, ages 6 months to <12 months, following administration of fluticasone propionate HFA.
- Trial name
- NCT00370097
- Testing
- FLOVENT (fluticasone propionate) HFA
- Where
- 7 sites in United States
- Volunteers
- 16 people
- Sponsor
- GlaxoSmithKline
Hypothalamic Obesity
A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients
The extension protocol is designed to allow those patients randomized to placebo in the core portion of the protocol to receive a 6 month treatment of open label octreotide and allow those patients randomized to octreotide who…
- Trial name
- NCT00171613
- Testing
- Octreotide
- Volunteers
- 32 people
- Sponsor
- Novartis
Hypercholesterolemia
A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)
Multiple-dose study to measure pharmacokinetics, pharmacodynamics and safety of bempedoic acid in pediatric participants 6 to 17 years of age with HeFH.
- Trial name
- CLEAR Path 1 (NCT05694260)
- Testing
- Bempedoic acid
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 31 people
- Sponsor
- Esperion Therapeutics, Inc.
Cartilage Disease
Non-interventional Study With NOVOCART® 3D for the Treatment of Cartilage Defects of the Knee in Pediatric Patients
Prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART 3D in the Treatment fo cartilage defects of the knee in pediatric patients wieh closed epiphyseal…
- Trial name
- JUNOVO (NCT04186208)
- Testing
- NOVOCART 3D
- Where
- 6 sites in Germany
- Volunteers
- 42 people
- Sponsor
- Tetec AG
Heterozygous or Homozygous Familial Hypercholesterolemia
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies
The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 (CKJX839C12301)…
- Trial name
- V-PEDS-OLE (NCT05682378)
- Testing
- Inclisiran
- Where
- 52 sites in United States, Argentina and 24 more
- Volunteers
- 195 people
- Sponsor
- Novartis Pharmaceuticals
Graft Versus Host Disease
Study of MEDI 507 in the Treatment of Pediatric Patients
To assess the safety of escalating dose levels of MEDI-507 in pediatric stem cell and bone marrow allograft recipients who have at least Grade II GvHD.
- Trial name
- Pediatric GvHD (NCT00813618)
- Testing
- MEDI-507
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- MedImmune LLC
Cerebral Palsy, Periventricular Leukomalacia
A Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients With Cerebral Palsy
UDI-001 is administered to pediatric patients with cerebral palsy attributed to periventricular leukomalacia (PVL) multiple times to investigate its safety and efficacy.
- Trial name
- NCT04873752
- Testing
- UDI-001
- Where
- Japan
- Volunteers
- 6 people
- Sponsor
- Rohto Pharmaceutical Co., Ltd.
ADHD
A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)
The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M.
- Trial name
- NCT00500149
- Testing
- Vyvanse (lisdexamfetamine dimesylate)
- Where
- 9 sites in United States
- Volunteers
- 129 people
- Sponsor
- Shire
Plexiform Neurofibroma, Neurofibromatosis Type 1 (NF1)
MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas
This study evaluates mirdametinib (PD-0325901) in the treatment of symptomatic inoperable neurofibromatosis type-1 (NF1)-associated plexiform neurofibromas (PNs). All participants will receive mirdametinib (PD-0325901).
- Trial name
- ReNeu (NCT03962543)
- Testing
- Mirdametinib (PD-0325901) oral capsule or dispersible tablet
- Where
- 43 sites in United States
- Volunteers
- 114 people
- Sponsor
- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
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