Clinical trials: Pediatric Disease
Dravet Syndrome (DS)
A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of convulsive seizures in children and young adults with DS.
- Trial name
- NCT04940624
- Testing
- Soticlestat
- Where
- 66 sites in United States, Australia and 16 more
- Volunteers
- 144 people
- Sponsor
- Takeda
Acne
Epiduo Pediatric Acne Study
The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.
- Trial name
- NCT01138735
- Testing
- adapalene/benzoyl peroxide, Topical Gel Vehicle
- Where
- 25 sites in United States, Canada
- Volunteers
- 285 people
- Sponsor
- Galderma R&D
Attention Deficit/Hyperactivity Disorder
Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children
The purpose of this study is to assess the long-term safety of Adhansia XR in children and to characterize the pharmacokinetics (PK) in 4 to 5 year-olds.
- Trial name
- NCT04987762
- Testing
- Adhansia XR
- Where
- 15 sites in United States
- Volunteers
- 103 people
- Sponsor
- Purdue Pharma LP
ALK Fusion-positive Solid or CNS Tumors
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents with ALK fusion-positive solid or CNS tumors for whom prior treatment has proven to be ineffective or for whom there is…
- Trial name
- NCT04774718
- Testing
- Alectinib
- Where
- 31 sites in United States, Australia and 9 more
- Volunteers
- 42 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis
Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis
Primary Objective: To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing…
- Trial name
- TERIKIDS (NCT02201108)
- Testing
- Teriflunomide
- Where
- 57 sites in United States, Belgium and 20 more
- Volunteers
- 166 people
- Sponsor
- Genzyme, a Sanofi Company
Glaucoma
A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.
To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.
- Trial name
- NCT00716859
- Testing
- Timolol, latanoprost
- Where
- 48 sites in United States, Belgium and 18 more
- Volunteers
- 139 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Cartilage Disease
Non-interventional Study in Pediatric Patients Treated With NOVOCART Inject in the Knee
The study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® Inject in the treatment of cartilage defects of the knee in pediatric patients with…
- Trial name
- NINJA (NCT05391841)
- Testing
- NOVOCART Inject
- Where
- 6 sites in Germany
- Sponsor
- Tetec AG
Acne Vulgaris
Study to Assess Safety, Pharmacokinetics, and Treatment Effect of Cabtreo
This study is to evaluate the safety, pharmacokinetics, and treatment effect for topically applied CABTREO lotion in pediatric participants ages 9 to 11 years, 11 months with Acne Vulgaris.
- Trial name
- NCT07524946
- Testing
- CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- Bausch Health Americas, Inc.
Non-Hodgkin Lymphoma
Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients
The purpose of the study was to assess the efficacy and safety of tisagenlecleucel in pediatric, adolescent and young adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) including Burkitt Lymphoma and…
- Trial name
- BIANCA (NCT03610724)
- Testing
- Tisagenlecleucel, lymphodepleting chemotherapy, Bridging Therapy
- Where
- 26 sites in United States, Australia and 12 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Anemia
Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients
The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.
- Trial name
- NCT00721188
- Testing
- Venofer
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- American Regent, Inc.
Hereditary Angioedema (HAE)
Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of…
- Trial name
- NCT02052141
- Testing
- CINRYZE 500, CINRYZE 1000
- Where
- 8 sites in United States, Germany and 3 more
- Volunteers
- 12 people
- Sponsor
- Shire
Neuroblastoma, Rhabdomyosarcoma
Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors
The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid tumors, and to see if it works to treat these solid tumors in children and young adults (in Phase 1 ≤ 18 years old and in Phase 2 ≤ 24…
- Conditions
- Neuroblastoma, Rhabdomyosarcoma, Ewing's Sarcoma, Ewing's Tumor
- Trial name
- NCT01962103
- Testing
- nab-paclitaxel
- Where
- 20 sites in United States, Canada and 5 more
- Volunteers
- 107 people
- Sponsor
- Celgene
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
Solid Tumors
A Multi-Center Phase I Study of Intravenous Deforolimus (AP23573, MK-8669) Administered QDX5 Every Other Week in Pediatric Patients With Advanced Solid Tumors (8669-028)(COMPLETED)
Ridaforolimus (Deforolimus, AP23573, MK-8669) is an mTor inhibitor shown to have promising activity in adults with a variety of solid malignancies, particularly the sarcomas.
- Trial name
- NCT00704054
- Testing
- ridaforolimus
- Volunteers
- 15 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Iron Overload
Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation
Extend evaluation of deferasirox film-coated tablet (FCT) formulation
- Trial name
- NCT02720536
- Testing
- Deferasirox
- Where
- 14 sites in Austria, Greece and 1 more
- Volunteers
- 53 people
- Sponsor
- Novartis Pharmaceuticals
Digestive System Diseases, Pancreatic Disease
Open Label Safety Study of DCI-1020 in Pediatric Cystic Fibrosis (CF) Patients
Hypothesis:DCI 1020 capsules are safe and effective in treating exocrine pancreatic insufficiency in CF patients <= 2 years of age.
- Conditions
- Digestive System Diseases, Pancreatic Disease, Cystic Fibrosis, Exocrine Pancreatic Insufficiency
- Trial name
- NCT00663975
- Testing
- DCI 1020
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Digestive Care, Inc.
Gastroesophageal Reflux Disease (GERD)
Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients
This study is a phase III, multi-centre, randomized, double-blind study to assess the safety and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and adolescent patients 12 to 17 years of age…
- Trial name
- NCT00241501
- Testing
- Esomeprazole (Nexium)
- Where
- 40 sites in United States, Canada and 2 more
- Volunteers
- 140 people
- Sponsor
- AstraZeneca
Venous Thromboembolism (VTE), Pulmonary Embolism
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE.
- Conditions
- Venous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT)
- Trial name
- NCT02798471
- Testing
- Edoxaban, Standard of Care
- Where
- 140 sites in United States, Argentina and 32 more
- Volunteers
- 290 people
- Sponsor
- Daiichi Sankyo
Atopic Dermatitis
Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in…
- Trial name
- NCT03911401
- Testing
- 0.3% OPA-15406, 1% OPA-15406
- Where
- Japan
- Volunteers
- 251 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Asthma
Pediatric Study to Evaluate Treatment of Persistent Moderate or Severe Asthma With the Association Fluticasone 250 mcg/Dose and Salmeterol 50 mcg/Dose - ADERE PROJECT
Prospective, parallel-group, randomized study to evaluate the compliance to the treatment of children aged between 6 and 14 years old with persistent moderate or severe asthma, receiving the association Fluticasone 250 mcg/dose…
- Trial name
- ADERE (Ped) (NCT01476059)
- Testing
- Telephone follow-up, No telephone follow-up
- Volunteers
- 472 people
- Sponsor
- GlaxoSmithKline
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