Clinical trials: Pediatric Disease
Uncomplicated Plasmodium Falciparum Malaria
Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria
This study aimed to determine the efficacy, safety and tolerability of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in pediatric patients (6 months to < 18 years of…
- Trial name
- KALUMI (NCT04546633)
- Testing
- KAF156, LUM-SDF, Coartem
- Where
- 9 sites in Burkina Faso, Côte d’Ivoire and 3 more
- Volunteers
- 295 people
- Sponsor
- Novartis Pharmaceuticals
Chickenpox, Herpes Zoster
Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is usually a self-limiting illness characterized by fever and a rash.
- Trial name
- NCT00098046
- Testing
- famciclovir
- Where
- 5 sites in United States, Costa Rica and 2 more
- Volunteers
- 76 people
- Sponsor
- Novartis
Carcinoid, Neuroendocrine
Safety Study of Seneca Valley Virus in Patients With Solid Tumors With Neuroendocrine Features
The primary purpose of the study is to determine if Seneca Valley Virus may be administered safely to patients with certain types of advanced cancer.
- Trial name
- NCT00314925
- Testing
- Seneca Valley Virus (biological agent)
- Where
- 10 sites in United States
- Volunteers
- 60 people
- Sponsor
- Neotropix
Epilepsy
Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old
The primary purpose of this study was to document the pharmacokinetic parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg of levetiracetam in epileptic pediatric subjects, aged 1 month…
- Trial name
- NCT00544050
- Testing
- Levetiracetam
- Volunteers
- 13 people
- Sponsor
- UCB Pharma
Primary Immunodeficiency Disease
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)
The purpose of this study is to assess efficacy, safety and pharmacokinetics of Kedrion Immunoglobulin 10% (KIg10) in pediatric patients with Primary Immunodeficiency Disease (PID).
- Trial name
- KIDCARES10 (NCT04944979)
- Testing
- Kedrion IVIG 10%
- Where
- 21 sites in United States, Hungary and 4 more
- Volunteers
- 30 people
- Sponsor
- Kedrion S.p.A.
Migraine
A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.
- Trial name
- PIONEER-PEDS1 (NCT04396236)
- Testing
- Lasmiditan
- Where
- 152 sites in United States, Belgium and 13 more
- Volunteers
- 847 people
- Sponsor
- Eli Lilly and Company
Allergic Rhinitis
Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age
The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal…
- Trial name
- NCT00794144
- Testing
- Olopatadine Hydrochloride Nasal Spray 0.6%, Olopatadine Hydrochloride Nasal Spray Vehicle
- Where
- United States
- Volunteers
- 132 people
- Sponsor
- Alcon Research
Muscular Atrophy, Spinal
A Study of RO6885247 in Adult and Pediatric Patients With Spinal Muscular Atrophy (MOONFISH)
This multicenter, randomized, double-blind, 12-week, placebo-controlled multiple dose study will investigate the safety and tolerability of RO6885247 in adult and pediatric patients with spinal muscular atrophy (SMA).
- Trial name
- NCT02240355
- Testing
- RO6885247
- Where
- 26 sites in United States, Canada and 7 more
- Volunteers
- 9 people
- Sponsor
- Hoffmann-La Roche
Hypertension, Chronic Kidney Disease
Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients
This study will assess the pharmacokinetics and safety following single dose of valsartan in Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.
- Conditions
- Hypertension, Chronic Kidney Disease, Nephrotic Syndrome
- Trial name
- NCT01447485
- Testing
- Valsartan (VAL489)
- Where
- 2 sites in Japan
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
Atopic Dermatitis
A Phase 1/2 Study of E6005 in Pediatric Subjects With Atopic Dermatitis
This is a multicenter, double-blind, vehicle-control study of 0.05% and 0.2% E6005 ointment. Pediatric subjects with atopic dermatitis (AD) will be grouped into two; an elder group (childhood - adolescent: 7 to 15 years of age)…
- Trial name
- NCT02094235
- Testing
- E6005 0.05%, E6005 0.2%
- Where
- 3 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Organon and Co
Muscular Dystrophy, Duchenne
Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy
The PolarisDMD study is a Phase 3, global study to evaluate the efficacy and safety of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD.
- Trial name
- PolarisDMD (NCT03703882)
- Testing
- Edasalonexent
- Where
- 40 sites in United States, Australia and 6 more
- Volunteers
- 131 people
- Sponsor
- Catabasis Pharmaceuticals
Hepatitis B
A Real-World Observational Study for the Safety and Efficacy of Baraclude in Korean Pediatric Patients With Chronic Hepatitis B
This is a local, prospective observational study (regulatory post marketing surveillance) to access the safety and effectiveness of Baraclude in Korean pediatric patients with chronic HBV infection who are between the ages of 2…
- Trial name
- NCT03426618
- Testing
- Non-interventional
- Where
- South Korea
- Volunteers
- 1 people
- Sponsor
- Bristol-Myers Squibb
Migraine
A Trial to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment…
- Trial name
- NCT04530110
- Testing
- Fremanezumab
- Where
- 70 sites in United States, Canada and 7 more
- Volunteers
- 499 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Allergic Reaction
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of DESF in Pediatric Subjects
An open-label study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of epinephrine administered as a single dose of DESF in pediatric subjects weighing ≥30 kg with a personal history of…
- Trial name
- PARKS (NCT07703982)
- Testing
- DESF
- Where
- 8 sites in United States, Canada
- Volunteers
- 32 people
- Sponsor
- Aquestive Therapeutics
Psoriasis
A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy.
- Trial name
- NCT04175613
- Testing
- Apremilast
- Where
- 50 sites in United States, Belgium and 7 more
- Volunteers
- 160 people
- Sponsor
- Amgen
Glycogen Storage Disease Type IA
Retrospective Study of Glucose Monitoring for Glycemic Control in Patients With GSDIa
The primary objective of this study is to assess the percentage of time patients were in normal glucose control.
- Trial name
- NCT04708015
- Testing
- No Intervention
- Where
- 2 sites in United States, Netherlands
- Volunteers
- 15 people
- Sponsor
- Ultragenyx Pharmaceutical 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.
Pulmonary Arterial Hypertension
Bosentan in Children With Pulmonary Arterial Hypertension
The aim of the study is to demonstrate that the exposure to bosentan in children with idiopathic pulmonary arterial hypertension (PAH) or familial pulmonary arterial hypertension, using a pediatric formulation, is similar to that…
- Trial name
- FUTURE-1 (NCT00319267)
- Testing
- Bosentan
- Volunteers
- 36 people
- Sponsor
- Actelion
Kawasaki Disease
A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects
The purpose of this Phase I-II multicenter clinical trial is to establish dosimetry and safety profiles for CARDIOLITE® (Technetium Tc99m Sestamibi) in pediatric subjects.
- Trial name
- NCT00162045
- Testing
- Technetium Tc99m Sestamibi
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 79 people
- Sponsor
- Lantheus Medical Imaging
Psoriasis, Plaque Psoriasis
Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216)
This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in pediatric subjects (ages 2 to 5 years old) with plaque psoriasis:
- Trial name
- NCT04746911
- Testing
- ARQ-151 cream 0.3%
- Where
- 18 sites in United States, Canada and 1 more
- Volunteers
- 10 people
- Sponsor
- Arcutis Biotherapeutics, Inc.
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