Clinical trials: Pediatric Neurological Disorder
Epilepsies, Partial
Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current…
- Trial name
- NCT00437281
- Testing
- Pregabalin
- Where
- 18 sites in United States, Mexico and 1 more
- Volunteers
- 65 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Narcolepsy With Cataplexy
A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy
The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics subjects with narcolepsy that includes cataplexy.
- Trial name
- NCT02221869
- Testing
- Xyrem
- Where
- 20 sites in United States, France and 2 more
- Volunteers
- 106 people
- Sponsor
- Jazz Pharmaceuticals
Migraine
A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine
The purpose of the study is the measure the levels of lasmiditan in the body of children aged 6 to 17 with migraine. The study also will also examine the safety and tolerability of lasmiditan in children aged 6 to 17 with…
- Trial name
- NCT03988088
- Testing
- Lasmiditan
- Where
- 11 sites in United States, Japan and 1 more
- Volunteers
- 18 people
- Sponsor
- Eli Lilly and Company
Tourette's Disorder (TD)
Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Participants With Tourette's Disorder
To evaluate the long-term efficacy of oral aripiprazole in pediatric participants for the treatment of Tourette's Disorder (TD).
- Trial name
- NCT03661983
- Testing
- Aripiprazole
- Where
- 42 sites in United States, Canada and 1 more
- Volunteers
- 36 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Obstructive Sleep Apnea
Comparing Auto-adjustable Positive Airway Pressure to Continuous Positive Airway Pressure in Children With Sleep Apnea
The purpose of this research study is to determine if auto-adjustable positive airway pressure (APAP) is an effective way to treat obstructive sleep apnea (OSA) in children.
- Trial name
- NCT01846988
- Testing
- crossover treatment (REMstar Auto A-Flex)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Ewing Sarcoma, Solid Tumors
Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults…
- Conditions
- Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma
- Trial name
- NCT03709680
- Testing
- Palbociclib, Temozolomide, Irinotecan
- Where
- 84 sites in United States, Brazil and 11 more
- Volunteers
- 128 people
- Sponsor
- Pfizer
Epilepsy, Anxiety
Use of Clobazam for Epilepsy and Anxiety
This study is an open label, adjunctive, proof of concept, pilot clinical trial. Pediatric patients with epilepsy and clinically significant anxiety will be recruited and if enrolled will receive active treatment, involving…
- Trial name
- NCT03371836
- Testing
- Clobazam
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Tourette Syndrome
Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-optimization study to evaluate the efficacy, safety, and tolerability of NBI-98854 titrated to the subject's optimal dose administered once daily (qd) for a…
- Trial name
- NCT03325010
- Testing
- Valbenazine
- Where
- 35 sites in United States, Puerto Rico
- Volunteers
- 127 people
- Sponsor
- Neurocrine Biosciences
Duchenne Muscular Dystrophy
A Gene Transfer Therapy Study to Evaluate the Safety of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)
This study was an open-label single-dose gene transfer therapy study evaluating the safety of delandistrogene moxeparvovec intravenous (IV) administration in boys with DMD.
- Trial name
- NCT03375164
- Testing
- delandistrogene moxeparvovec
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Sarepta Therapeutics, Inc.
Growth Hormone Deficiency, Pediatric, Endocrine System Diseases
A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency
A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered once-a-week. Approximately 150 children (males and females) with growth hormone deficiency (GHD) will be included.
- Conditions
- Growth Hormone Deficiency, Pediatric, Endocrine System Diseases, Hormone Deficiency, Pituitary Diseases
- Trial name
- NCT03305016
- Testing
- TransCon hGH
- Where
- 24 sites in United States, Australia and 2 more
- Volunteers
- 146 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Childhood Solid Neoplasm, Recurrent Malignant Solid Neoplasm
Nanoparticle Albumin-Bound Rapamycin, Temozolomide, and Irinotecan Hydrochloride in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors
This phase I trial studies the side effects and best dose of nanoparticle albumin-bound rapamycin when given together with temozolomide and irinotecan hydrochloride in treating pediatric patients with solid tumors that have come…
- Conditions
- Childhood Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Primary Central Nervous System Neoplasm, Refractory Malignant Solid Neoplasm
- Trial name
- NCT02975882
- Testing
- Irinotecan Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 21 sites in United States
- Volunteers
- 33 people
- Sponsor
- Children's Oncology Group
Seizure, Epilepsy
A Safety and Feasibility Study of Enteral LVT vs. Standard of Care for Seizure Control in Pediatric CM
Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20% and leaving one third of survivors with long term neurologic and psychiatric sequelae.
- Conditions
- Seizure, Epilepsy, Cerebral Malaria
- Trial name
- LVT2 (NCT01982812)
- Testing
- Oral Levetiracetam, Standard AED
- Where
- Malawi
- Volunteers
- 44 people
- Sponsor
- University of Rochester
Growth Hormone Deficiency
Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects
Convenience and preference for the new Mark VII pen compared to the current Genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.
- Trial name
- CHOOSE (NCT01112865)
- Testing
- Genotropin Pen, MARK VII pen
- Where
- 23 sites in Czechia, Germany and 5 more
- Volunteers
- 120 people
- Sponsor
- Pfizer
Multiple Sclerosis
A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT
Primary Objective: To evaluate the efficacy, safety, and tolerability of alemtuzumab intravenously (IV) in pediatric participants from 10 to less than (<) 18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who…
- Trial name
- LemKids (NCT03368664)
- Testing
- Alemtuzumab GZ402673, Glatiramer acetate, Beta-Interferon
- Where
- 13 sites in France, Italy and 4 more
- Volunteers
- 16 people
- Sponsor
- Genzyme, a Sanofi Company
Post Operative Pain
Parent Nurse Controlled Analgesic in Pediatric Patients With Developmental Delay
The purpose of this study is to compare, the safety, efficacy and level of parent and nurse satisfaction with three methods of opioid administration post-operatively in children (4-18 years of age) with developmental delay.
- Trial name
- PNCA (NCT00743730)
- Testing
- Pain and standard side effect management for PNCA with basal method., Pain and standard side effect management with PNCA without basal, Pain and standard side effect management with IV on an as needed basis method.
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Medical College of Wisconsin
Gaucher Disease
A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in pediatric subjects (2 to <18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocols…
- Trial name
- NCT01411228
- Testing
- Taliglucerase alfa
- Where
- 3 sites in Israel, Paraguay and 1 more
- Volunteers
- 15 people
- Sponsor
- Pfizer
Anxiety, Separation, Psychomotor Agitation
Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia
Nearly 50% of young children undergoing surgery exhibit high level of anxiety during induction of anesthesia because of exposure to unfamiliar environment and people and separation from parents.
- Trial name
- NCT02027844
- Testing
- Cartoon, parental presence
- Where
- South Korea
- Volunteers
- 117 people
- Sponsor
- Yeungnam University College of Medicine
Hunter Syndrome
An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment
This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV)…
- Trial name
- NCT01506141
- Testing
- Idursulfase-IT, Elaprase
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 15 people
- Sponsor
- Takeda
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.
Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet…
- Conditions
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- Trial name
- NCT04485104
- Testing
- GWP42003-P
- Where
- 11 sites in United States, Italy and 1 more
- Volunteers
- 3 people
- Sponsor
- Jazz Pharmaceuticals