Clinical trials: Neuromuscular Diseases in Children
Attention Deficit Hyperactivity Disorder (ADHD)
Safety, Tolerability and Pharmacokinetics of SHP465 in Children Aged 4 to 5 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of SHP465 in children aged 4 to 5 years with ADHD after multiple daily doses of 6.25 milligram (mg) SHP465
- Trial name
- NCT03327402
- Testing
- SHP465
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Shire
Poliomyelitis, Polio
Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan
The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose.
- Trial name
- NCT02005536
- Testing
- IMOVAX POLIO®: Inactive Poliovirus Vaccine
- Where
- 4 sites in Japan
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Poliomyelitis
Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine
The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90…
- Trial name
- NCT02985320
- Testing
- Single-dose regimen of high dosage investigational sIPV, Single-dose regimen of medium dosage investigational sIPV, Three-dose regimen of high dosage investigational sIPV
- Where
- China
- Volunteers
- 708 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Myasthenia Gravis
A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (<) 18 years of age (globally) and 8 to <18 years of age (for Unites Stated (US)…
- Trial name
- NCT05265273
- Testing
- Nipocalimab
- Where
- 19 sites in United States, Japan and 2 more
- Volunteers
- 12 people
- Sponsor
- Janssen Research & Development, LLC
Duchenne Muscular Dystrophy
Microdystrophin Gene Transfer Study in Adolescents and Children With DMD
This is a controlled, open-label, single-ascending dose study to evaluate the safety and tolerability of SGT-001 in adolescents and children with Duchenne muscular dystrophy (DMD).
- Trial name
- IGNITE DMD (NCT03368742)
- Testing
- SGT-001
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Solid Biosciences Inc.
Generalized Myasthenia Gravis
A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis
The purpose of this study is to measure the pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability, and immunogenicity of efgartigimod PH20 SC in pediatric participants with gMG aged 2 to <18 years.
- Trial name
- ADAPT Jr SC (NCT06392386)
- Testing
- Efgartigimod PH20 SC
- Where
- 22 sites in United States, Australia and 12 more
- Volunteers
- 12 people
- Sponsor
- argenx
Tetanus, Poliomyelitis
Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.
- Conditions
- Tetanus, Poliomyelitis, Haemophilus Influenzae Type b, Acellular Pertussis
- Trial name
- NCT01358825
- Testing
- Blood Sampling
- Where
- 4 sites in Norway, Sweden
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Attention Deficit Hyperactivity Disorder (ADHD)
Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years
The purpose of this study is to evaluate the efficacy and safety of SHP465 at 6.25 mg in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6-12 years.
- Trial name
- NCT03325881
- Testing
- SHP465
- Where
- 41 sites in United States
- Volunteers
- 89 people
- Sponsor
- Shire
Polio
Immunogenicity of After Primary Immunization and Booster Immunization of sIPV
This study was conducted on the basis of "Safety Observation of Sabin Strain Inactivated Polio Vaccine (Vero Cell) on primary Immunization, Booster Immunization and Simultaneous Vaccination with Other Vaccines in Infants and…
- Trial name
- NCT06058429
- Testing
- no intervention
- Where
- China
- Volunteers
- 233 people
- Sponsor
- Sinovac Biotech Co., Ltd
Cerebral Palsy, Spasticity
Exopulse Mollii Suit, Motor Functions & CP Children With Cerebral Palsy
Cerebral Palsy (CP) is is estimated to be around 1.5-3 per live birth, with prenatal factors accounting for 75% of cases. CP appears in early childhood and persists with age and is characterized by permanent lesions or…
- Conditions
- Cerebral Palsy, Spasticity, Muscle, Pain Syndrome
- Trial name
- EXOCEP2GER (NCT05885139)
- Testing
- Exopulse Mollii Suit
- Where
- 2 sites in Germany
- Volunteers
- 34 people
- Sponsor
- Exoneural Network AB
Osteoporosis
An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
This study was designed to evaluate the efficacy and safety of zoledronic acid compared to placebo in osteoporotic children treated with glucocorticoids
- Trial name
- NCT00799266
- Testing
- Zoledronic acid
- Where
- 12 sites in Australia, Canada and 4 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Attention Deficit Hyperactivity Disorder (ADHD), Anxiety Disorders and Symptoms
Safety and Efficacy of Mexidol® for ADHD in Children Aged 6-12
The primary objective of this study was to evaluate the efficacy and safety of Mexidol® film-coated tablets (125 mg) compared to a placebo in children aged 6 to 12 years with Attention Deficit Hyperactivity Disorder (ADHD).
- Trial name
- MEGA (NCT06854601)
- Testing
- Mexidol
- Where
- 14 sites in Russia
- Volunteers
- 333 people
- Sponsor
- Pharmasoft
Attention Deficit Hyperactivity Disorder, ADHD
Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting
The time course of response following one dose of a new methylphenidate hydrochloride extended release capsule is studied in children 6-12 years in a simulated laboratory classroom setting.
- Trial name
- NCT01269463
- Testing
- Methylphenidate Hydrochloride Extended Release Capsule
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Rhodes Pharmaceuticals, L.P.
Mitochondrial Diseases
A Long-term Extension of Study RP103-MITO-001 (NCT02023866) to Assess Cysteamine Bitartrate Delayed-release Capsules (RP103) in Children With Inherited Mitochondrial Disease
A long-term extension study to assess the safety, tolerability and efficacy of cysteamine bitartrate delayed-release capsules (RP103) in children with inherited mitochondrial diseases who previously enrolled into study…
- Trial name
- NCT02473445
- Testing
- Cysteamine Bitartrate
- Where
- 5 sites in United States
- Volunteers
- 22 people
- Sponsor
- Amgen
Osteoporosis
1 Year Open-label Extension to CZOL446H2337 Safety and Efficacy Trial of Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
This 1-year open-label extension to CZOL446H2337 is designed to evaluate the safety and efficacy of zoledronic acid twice yearly in osteoporotic children treated with glucocorticoids.
- Trial name
- NCT01197300
- Testing
- Zoledronic acid
- Where
- 10 sites in Australia, Canada and 4 more
- Volunteers
- 25 people
- Sponsor
- Novartis Pharmaceuticals
Cancer
Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations
This was a 4-part (Part A, Part B, Part C and Part D), Phase I/IIa, multi-center, open label, study in pediatric subjects with refractory or recurrent tumors.
- Trial name
- NCT02124772
- Testing
- Trametinib, Dabrafenib
- Where
- 16 sites in United States, Australia and 3 more
- Volunteers
- 139 people
- Sponsor
- Novartis Pharmaceuticals
Inherited Mitochondrial Disease, Including Leigh Syndrome
Open-Label, Dose-Escalating Study Assessing Safety, Tolerability, Efficacy, of RP103 in Mitochondrial Disease
To evaluate safety, tolerability and efficacy of cysteamine bitartrate delayed-release capsules (RP103) administered at a target maintenance dose of 1.3 g/m²/day in two divided doses, every 12 hours, for up to 6 months in…
- Trial name
- MITO-001 (NCT02023866)
- Testing
- Cysteamine Bitartrate
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Amgen
Diphtheria, Pertussis
Retrospective Survey of Safety of Fourth Dose Pentacel® in Children
The purpose of this survey is to collect selected safety data. Primary Objective: To collect selected safety data at 6 months following the 4th dose of the Pentacel® series.
- Conditions
- Diphtheria, Pertussis, Haemophilus Infection, Tetanus
- Trial name
- NCT00772369
- Where
- Canada
- Volunteers
- 3,214 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years
The study objective is to assess the immunogenicity and safety of DTaP-IPV combination vaccine administered as a boosting dose to healthy 4 to 6-year-old children who received three doses of primary immunization against…
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- Aladdin (NCT04618640)
- Testing
- DTaP-IPV combination vaccine
- Where
- 26 sites in South Korea
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- Boryung Biopharma Co., Ltd.