Clinical trials: Pediatric Neurological Disorder
Meningococcal Infections
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe
Primary objective: This study aimed to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared…
- Trial name
- NCT03547271
- Testing
- MenACYW conjugate vaccine, Meningococcal group A, C, W-135, and Y conjugate vaccine, DTaP-IPV-HB-Hib vaccine
- Where
- 33 sites in Czechia, Finland and 5 more
- Volunteers
- 1,660 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Brain and Central Nervous System Tumors, Cognitive/Functional Effects
Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain
RATIONALE: Donepezil may decrease the side effects caused by radiation therapy to the brain. PURPOSE: This clinical trial is studying how well donepezil works in treating young patients with primary brain tumors previously…
- Conditions
- Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Long-term Effects Secondary to Cancer Therapy in Children, Neurotoxicity
- Trial name
- NCT00452868
- Testing
- Donepezil
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Wake Forest University Health Sciences
Cerebral Palsy, Muscle Spasticity
Dysport® Pediatric Lower Limb Spasticity Study
The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy.
- Conditions
- Cerebral Palsy, Muscle Spasticity, Children
- Trial name
- NCT01249417
- Testing
- Botulinum toxin type A
- Where
- 29 sites in United States, Chile and 4 more
- Volunteers
- 241 people
- Sponsor
- Ipsen
Pain, Anxiety
Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief
The purpose of this study is to test the effectiveness of Buzzy®, a battery-powered reusable device that provides cold and vibration, in reducing the pain associated with intravenous (IV) cannulation.
- Trial name
- NCT01394250
- Testing
- Buzzy, Topical Lidocaine 4% Cream
- Where
- United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Amnesia
Nitrous Oxide Induction Induces Amnesia in Pediatric Patients
The investigators are conducting a study to investigate the amnestic effects of 2 different concentrations of nitrous oxide in children before induction of anesthesia in a prospective double-blinded placebo controlled study.
- Trial name
- NCT02050152
- Testing
- Nitrous Oxide 0%, Nitrous oxide 33%, Nitrous oxide 66%
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- State University of New York at Buffalo
Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma
Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well vemurafenib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations that have spread to other places in the body…
- Conditions
- Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma, Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma, Ependymoma
- Trial name
- NCT03220035
- Testing
- Laboratory Biomarker Analysis, Vemurafenib
- Where
- 116 sites in United States, Puerto Rico
- Volunteers
- 4 people
- Sponsor
- National Cancer Institute (NCI)
Growth Disorders
Long-Acting Growth Hormone in Children Compared to Daily rhGH
The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of treatment effect against daily injections of rhGH.
- Trial name
- VELOCITY (NCT02339090)
- Testing
- Somavaratan, rhGH
- Volunteers
- 138 people
- Sponsor
- Versartis Inc.
Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma
Selumetinib Sulfate in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well selumetinib sulfate works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway activation mutations that have spread to…
- Conditions
- Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma, Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma, Recurrent Childhood Central Nervous System Neoplasm
- Trial name
- NCT03213691
- Testing
- Laboratory Biomarker Analysis, Selumetinib, Selumetinib Sulfate
- Where
- 110 sites in United States, Puerto Rico
- Volunteers
- 21 people
- Sponsor
- National Cancer Institute (NCI)
Peripheral Nerve Sheath Tumor
Tazemetostat in Malignant Peripheral Nerve Sheath Tumors
This phase 2, open label, single arm study will investigate the use of tazemetostat in patients with recurrent/refractory and/or metastatic malignant peripheral nerve sheath tumors.
- Trial name
- NCT04917042
- Testing
- Tazemetostat
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Florida
Sleep, Sleep Disturbance
Sleep Promotion Program Primary Care (SPP PC) Open Trial
Investigators developed a brief, scalable, behavioral Sleep Promotion Program (SPP) for adolescents with short sleep duration and sleep-wake irregularity, which relies on one individual session and smart phone technology to…
- Conditions
- Sleep, Sleep Disturbance, Insufficient Sleep
- Trial name
- SPP OT (NCT06239792)
- Testing
- Sleep Promotion Program
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of Pittsburgh
Cheilitis, Angular, Postoperative Complications
Using Dexpanthenol Cream to Prevent Lip Corner Cracks in Children After Tonsil/Adenoid Surgery
Soreness and cracking at the corners of the mouth, a condition called angular cheilitis, can be an uncomfortable problem for children after they have surgery to remove their tonsils and adenoids.
- Conditions
- Cheilitis, Angular, Postoperative Complications, Adenotonsillar Hypertrophy
- Trial name
- PrevAC-PedAT (NCT07002632)
- Testing
- Dexpanthenol 5 % Topical Ointment
- Where
- Turkey (Türkiye)
- Volunteers
- 106 people
- Sponsor
- Gaziosmanpasa Research and Education Hospital
Duchenne Muscular Dystrophy
A Study to Evaluate Safety, Tolerability, and Efficacy of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) Who Have Completed Study 4658-102 (NCT03218995)
The purpose of this extension study is to evaluate the ongoing safety and tolerability of additional treatment with eteplirsen administered once weekly by intravenous (IV) infusion in male participants with DMD who have…
- Trial name
- NCT03985878
- Testing
- Eteplirsen
- Where
- 4 sites in Belgium, France and 2 more
- Volunteers
- 15 people
- Sponsor
- Sarepta Therapeutics, Inc.
Relapsed Solid Tumor, Refractory Solid Tumor
A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma
The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did…
- Trial name
- NCT04238819
- Testing
- Abemaciclib, Irinotecan, Temozolomide
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 47 people
- Sponsor
- Eli Lilly and Company
Myasthenia Gravis, Myasthenia Gravis, Juvenile Form
A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of eculizumab in the treatment of pediatric refractory gMG based on change from Baseline in the Quantitative Myasthenia Gravis…
- Conditions
- Myasthenia Gravis, Myasthenia Gravis, Juvenile Form, Myasthenia Gravis, Generalized
- Trial name
- NCT03759366
- Testing
- Eculizumab
- Where
- 11 sites in United States, Japan
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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
Central Nervous System Tumor, Pediatric, Neuroblastoma
Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma
RATIONALE: Thalidomide may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or…
- Trial name
- NCT00098865
- Testing
- temozolomide, thalidomide
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Dana-Farber Cancer Institute
Epilepsy, Partial Seizures
A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either…
- Trial name
- PERIWINKLE (NCT01389596)
- Testing
- Pregabalin add-on therapy
- Where
- 86 sites in United States, Belgium and 16 more
- Volunteers
- 295 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Epilepsy, Dravet Syndrome
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Trial name
- ELEKTRA (NCT03650452)
- Testing
- TAK-935
- Where
- 44 sites in United States, Australia and 6 more
- Volunteers
- 141 people
- Sponsor
- Takeda
Mixed Hearing Loss, Single-Sided Deafness
Osia 2 Pediatric Expansion Study
The CochlearTM Osia®2 System was cleared by the Food and Drug Administration November 15, 2019 (K191921) for individuals aged 12 years and older who present with conductive or mixed hearing loss (up to 55 dB HL) or…
- Conditions
- Mixed Hearing Loss, Single-Sided Deafness, Conductive Hearing Loss
- Trial name
- NCT05000931
- Testing
- Osia 2 System
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cochlear
Epilepsy
Bridging the Childhood Epilepsy Treatment Gap in Africa
About half of the world's children with epilepsy do not receive treatment - known as the epilepsy treatment gap - with significantly higher rates (67%-90%) in low- and middle-income countries (LMICs).
- Trial name
- BRIDGE (NCT04290975)
- Testing
- Task-shifting epilepsy care to epilepsy-trained community health workers (CHWs), Enhanced usual care for epilepsy (EUC)
- Where
- 3 sites in Nigeria
- Volunteers
- 1,672 people
- Sponsor
- Vanderbilt University Medical Center