Clinical trials: Pediatric Safety and Effectiveness
Spasticity, Cerebral Palsy
Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity
Oral baclofen is used commonly to treat spasticity in children with cerebral palsy. Although for adults there is dosing,safety and efficacy information in the package insert, this is not the case for children.
- Trial name
- Best PK/PD (NCT00607542)
- Testing
- baclofen
- Where
- 11 sites in United States
- Volunteers
- 61 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Cord Blood Transplant, Hematologic Malignancy
Evaluation of the Safety and Efficacy of TXA127 (Angiotensin 1-7) to Enhance Engraftment in Pediatric Patients Undergoing Single or Double Umbilical Cord Blood Transplantation
Engraftment failure is a major obstacle to the success of cord blood transplantation in children with malignancies and inherited metabolic disorders, despite the fact that they receive relatively high doses of nucleated cells…
- Conditions
- Cord Blood Transplant, Hematologic Malignancy, Inherited Metabolic Disease
- Trial name
- NCT01554254
- Testing
- TXA127
- Where
- United States
- Sponsor
- Tarix Pharmaceuticals
Psoriasis Vulgaris, Psoriatic Arthritis
Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP
This was a multicenter, centrally registered observational study without a control group. This observational study was a specified drug use-results survey conducted under GPSP to collect information on safety and efficacy during…
- Conditions
- Psoriasis Vulgaris, Psoriatic Arthritis, Pustular Psoriasis
- Trial name
- NCT05215561
- Testing
- Cosentyx
- Where
- 21 sites in Japan
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Morbid Obesity, Bariatric Surgery
Registry on Obesity Surgery in Adolescents
While bariatric surgery is established as a safe and effective alternative with well-defined risks for severely obese adults, little has been published on its use in children.
- Conditions
- Morbid Obesity, Bariatric Surgery, Adolescent Obesity
- Trial name
- ROSA (NCT03203161)
- Testing
- bariatric surgery
- Where
- 3 sites in Belgium
- Volunteers
- 50 people
- Sponsor
- Queen Fabiola Children's University Hospital
Neutropenia, Fungal Disease
Micafungin Prevention Study for Invasive Fungal Disease in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.
- Trial name
- NCT01417169
- Testing
- micafungin
- Where
- South Korea
- Volunteers
- 112 people
- Sponsor
- Seoul National University Hospital
Diarrhea-Associated Hemolytic Uremic Syndrome, Pediatric Kidney Disease
A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS
Hemolytic Uremic Syndrome (HUS) is a foodborne disease which mainly affects children. It is caused by Escherichia coli bacteria, which release a toxin called Shiga toxin within the body.
- Conditions
- Diarrhea-Associated Hemolytic Uremic Syndrome, Pediatric Kidney Disease, Hemolytic-Uremic Syndrome
- Trial name
- NCT05569746
- Testing
- INM004, SoC
- Where
- 16 sites in Argentina
- Volunteers
- 57 people
- Sponsor
- Inmunova S.A.
Partial Seizures
A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study)
The purpose of this study is to assess the long-term safety and efficacy of zonisamide used as an adjunctive treatment in pediatric subjects treated with 1 or 2 other anti-epileptic drugs (AEDs).
- Trial name
- NCT01136954
- Testing
- Zonisamide
- Where
- Italy
- Volunteers
- 144 people
- Sponsor
- Eisai Limited
B-cell Acute Lymphoblastic Leukemia
A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)
This is a multi-center, phase Ib/II trial to evaluate the safety and efficacy of CNCT19 treatment in Children and Adolescent (pediatric) patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).
- Trial name
- NCT05667506
- Testing
- single dose of CNCT19
- Where
- 9 sites in China
- Volunteers
- 47 people
- Sponsor
- Juventas Cell Therapy Ltd.
Muscular Atrophy, Spinal
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered in Pediatric Patients With Spinal Muscular Atrophy Who Experienced a Plateau or Decline in Function After Gene Therapy
This is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered in pediatric participants with SMA and 2 SMN2 copies who previously received onasemnogene…
- Trial name
- HINALEA 2 (NCT05861999)
- Testing
- Risdiplam
- Where
- 17 sites in United States, Germany and 4 more
- Volunteers
- 19 people
- Sponsor
- Hoffmann-La Roche
Vitiligo, Pediatric ALL
Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children
Vitiligo is a auto immune that impact 2% of the global population, regardless from the phototype. Even though it affects patients in a physical way through loss of pigmentation, it is also impacting them on a mental/emotional…
- Conditions
- Vitiligo, Pediatric ALL, Dermatologic Disease, Autoimmune Diseases
- Trial name
- NCT06035614
- Testing
- exciplex, Tacrolimus ointment
- Where
- Jordan
- Volunteers
- 50 people
- Sponsor
- Clarteis
Hypophosphatemia, Hypophosphatemic Rickets
Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic Rickets
A 52 week, open label trial to assess the safety and efficacy of KRN23, an investigational antibody to FGF23, in a single pediatric patient with Epidermal Nevus Syndrome(ENS) and associated hypophosphatemic rickets A 26 weeks…
- Conditions
- Hypophosphatemia, Hypophosphatemic Rickets, Pain, Chronic
- Trial name
- NCT03581591
- Testing
- Burosumab
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Redwood Dermatology Sciences
Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia, Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)
This is a Phase 1b/2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 in pediatric patients with relapsed or refractory…
- Trial name
- NCT06173518
- Testing
- AUTO1
- Where
- 14 sites in United States, Spain and 1 more
- Volunteers
- 30 people
- Sponsor
- Autolus Limited
Irritability Associated With Autistic Disorder
Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder
The purpose of this study is to determine whether pediatric participants with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when…
- Trial name
- NCT01227668
- Testing
- Aripiprazole
- Where
- 38 sites in United States
- Volunteers
- 215 people
- Sponsor
- Bristol-Myers Squibb
Diarrhea, Gastroenteritis
Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
The goal of this clinical trial is to learn how rifaximin 200 mg is processed in the body (pharmacokinetics) in children 6 to 11 years old with acute diarrhea that may be caused by bacteria.
- Conditions
- Diarrhea, Gastroenteritis, Bacterial Infection, Acute Diarrhea
- Trial name
- NCT07285785
- Testing
- Rifaximin 200 mg Tablet, Oral Rehydration Therapy (ORT)
- Where
- 10 sites in United States
- Volunteers
- 54 people
- Sponsor
- Bausch Health Americas, Inc.
Burns
Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients
The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours…
- Trial name
- NCT00606489
- Testing
- Caldolor
- Where
- 5 sites in United States, India
- Volunteers
- 61 people
- Sponsor
- Cumberland Pharmaceuticals
Renal Insufficiency, Chronic
Efficacy and Safety Study to Delay Renal Failure in Children With Alport Syndrome
This is a phase III, multi-centre, randomised, placebo-controlled, patient and investigator-blind study in paediatric patients with early stages of Alport syndrome to assess the safety and efficacy of the ACEi ramipril in slowing…
- Trial name
- NCT01485978
- Testing
- Ramipril
- Where
- Germany
- Volunteers
- 66 people
- Sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Primary Immune Deficiency
An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD)
This is a Phase IV, multicenter, open-label study of Asceniv™ administered as an intravenous infusion of Asceniv™ (IGIV) 300-800 mg/kg every 21 or 28 days in approximately 12 pediatric subjects with Primary Immunodeficiency…
- Trial name
- NCT05070455
- Testing
- Asceniv™
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- ADMA Biologics, Inc.
Neutropenia, Hematopoietic Stem Cell Transplantation
Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation
This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.
- Conditions
- Neutropenia, Hematopoietic Stem Cell Transplantation, Invasive Fungal Disease
- Trial name
- NCT01135589
- Testing
- Micafungin
- Where
- 7 sites in South Korea
- Volunteers
- 145 people
- Sponsor
- Asan Medical Center
Non-Segmental Vitiligo
A Study to Learn How Effective, Safe, and Tolerable Upadacitinib is for Young Participants With Non-segmental Vitiligo
Vitiligo is a common, long-lasting disease that happens when the immune system attacks melanocytes (skin cells that produce the skin-coloring pigment melanin) in the skin leading to loss of color.
- Trial name
- Ph3 Peds Viti (NCT07896434)
- Testing
- Upadacitinib
- Volunteers
- 154 people
- Sponsor
- AbbVie
Colitis, Ulcerative
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction…
- Trial name
- QUASAR Jr (NCT06260163)
- Testing
- Guselkumab Subcutaneous, Guselkumab Intravenous
- Where
- 61 sites in United States, Australia and 11 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
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