Clinical trials: Open Label
Stereotypical Prolonged Seizures
A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.
- Trial name
- NCT05076617
- Testing
- Staccato alprazolam
- Where
- 136 sites in United States, Australia and 10 more
- Volunteers
- 300 people
- Sponsor
- UCB Biopharma SRL
Urea Cycle Disorders, Crigler Najjar Syndrome
Safety Study of HepaStem for the Treatment of Urea Cycle Disorders (UCD) and Crigler-Najjar Syndrome (CN)
The purpose of this study is to assess the safety and to appraise the efficacy of one cycle of Hepastem (Heterologous Human Adult Liver-derived Progenitor Cells, HHALPC) infusions in paediatric patients suffering from CN or UCD.
- Trial name
- HEP001 (NCT01765283)
- Testing
- HepaStem
- Where
- 11 sites in Belgium, France and 3 more
- Volunteers
- 20 people
- Sponsor
- Cellaion SA
Cystic Fibrosis
A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if deemed appropriate by the Investigators will be…
- Trial name
- CT03Ext (NCT01111383)
- Testing
- tobramycin
- Where
- 20 sites in France, Poland and 1 more
- Volunteers
- 209 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Hunter Syndrome
Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter…
- Trial name
- AIM-IT (NCT02055118)
- Testing
- idursulfase-IT, No IT treatment
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 58 people
- Sponsor
- Shire
Crohn Disease, Colitis, Ulcerative
A Long-term Extension Study of Ustekinumab in Pediatric Participants
The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
- Conditions
- Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic
- Trial name
- UNITED (NCT05092269)
- Testing
- Ustekinumab
- Where
- 48 sites in United States, Argentina and 11 more
- Volunteers
- 159 people
- Sponsor
- Janssen Research & Development, LLC
Refractory Bone or Joint Infections
Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections
To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.
- Trial name
- NCT02569541
- Testing
- sodium fusidate
- Where
- 19 sites in United States
- Volunteers
- 30 people
- Sponsor
- Arrevus Inc.
Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP
A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients With Immune (Idiopathic) Thrombocytopenia Purpura
This is an extension study designed to assess the safety and durability of platelet count increases with romiplostim treatment of thrombocytopenic patients with immune (Idiopathic) thrombocytopenia purpura.
- Trial name
- NCT01071954
- Testing
- Romiplostim
- Where
- 31 sites in United States, Australia and 2 more
- Volunteers
- 66 people
- Sponsor
- Amgen
Pulmonary Arterial Hypertension
Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH
An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial Hypertension (PAH)
- Trial name
- NCT02652429
- Testing
- Inhaled Nitric Oxide
- Where
- 17 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- Bellerophon Pulse Technologies
Leber Congenital Amaurosis 10, Blindness
An Open-label, Dose Escalation and Double-masked, Randomized, Controlled Trial Evaluating Safety and Tolerability of Sepofarsen in Children (<8 Years of Age) With LCA10 Caused by Mutations in the CEP290 Gene.
PQ-110-005 (BRIGHTEN) is an open-label, dose escalation and double-masked, randomized, controlled study evaluating safety and tolerability of sepofarsen administered via intravitreal (IVT) injection in pediatric subjects (<8…
- Conditions
- Leber Congenital Amaurosis 10, Blindness, Leber Congenital Amaurosis, Vision Disorders
- Trial name
- BRIGHTEN (NCT04855045)
- Testing
- sepofarsen
- Where
- 9 sites in Belgium, Brazil and 5 more
- Volunteers
- 15 people
- Sponsor
- ProQR Therapeutics
Infantile Colic, Gastroesophageal Reflux (GER)
BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
Infants often experience functional gastrointestinal symptoms (e.g., colic, excessive gas, regurgitation, constipation, or loose stools) that distress families and may reflect an imbalance of the gut microbiome.
- Conditions
- Infantile Colic, Gastroesophageal Reflux (GER), Functional Constipation, Functional Diarrhea
- Trial name
- CTBE2503 (NCT07148583)
- Testing
- BioAmicus Complete, Usual Care (No Probiotic)
- Where
- Vietnam
- Volunteers
- 110 people
- Sponsor
- Haiphong University of Medicine and Pharmacy
Healthy
A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children
Open label, single arm, multicenter study of the shedding and safety of a single dose of trivalent, influenza virus vaccine live, intranasal in children 6 to < 60 months of age, with 28-day shedding follow-up and 180-day safety…
- Trial name
- NCT00344305
- Testing
- Trivalent influenza virus vaccine live, intranasal
- Where
- 16 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Neonatal Abstinence Syndrome, Neonatal Opiate Withdrawal Syndrome
Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure
Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine.
- Trial name
- B-PHORE (NCT03608696)
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Thomas Jefferson University
Keratoconjunctivitis, Conjunctivitis
Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis
To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients with vernal keratoconjunctivitis
- Trial name
- NCT00567918
- Testing
- FK506
- Where
- 8 sites in Japan
- Volunteers
- 52 people
- Sponsor
- Astellas Pharma Inc
Attention Deficit Hyperactivity Disorder
Neuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.
The purpose of this study is to evaluate the change in neuropsychological status from baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5 diagnosed with ADHD.
- Trial name
- NCT00216918
- Testing
- Atomoxetine Hydrochloride
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Eli Lilly and Company
Cervical Cancer, Vulvar Cancer
Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4…
- Conditions
- Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts
- Trial name
- NCT03158220
- Testing
- V503
- Where
- 24 sites in Austria, Belgium and 4 more
- Volunteers
- 1,212 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection
The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis C virus…
- Trial name
- NCT02249182
- Testing
- LDV/SOF, RBV
- Where
- 31 sites in United States, Australia and 2 more
- Volunteers
- 226 people
- Sponsor
- Gilead Sciences
Undernutrition
Study of Blood Parameters of the Malnourished Children: Before and After Giving Nutritional Biscuit's Treatment
Present study was designed to evaluate the efficacy of the nutritional intervention, in the SAM (Severe Acute malnutrition)children by monitoring various Anthropometric,Biochemical ,Hormonal and Enzymatic parameters before and…
- Trial name
- NCT02459223
- Testing
- Nutritional biscuits and khichadi, Khichadi
- Where
- India
- Volunteers
- 105 people
- Sponsor
- Maharashtra University of Health Sciences
Contraception
Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)
This study is a Phase III, multicenter, open-label, single-arm clinical trial designed to evaluate the contraceptive efficacy and safety of a new formulation containing N0999 in women of childbearing potential.
- Trial name
- LUNA (NCT07714616)
- Testing
- Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg
- Where
- Brazil
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- Eurofarma Laboratorios S.A.
Autism Spectrum Disorders, Pervasive Developmental Disorders
An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders
This study is an 8-week open-label trial testing oxytocin nasal spray (Syntocinon) as a treatment for social impairment in adolescents with autism spectrum disorders (ASD).
- Conditions
- Autism Spectrum Disorders, Pervasive Developmental Disorders, ASD, PDD
- Trial name
- NCT01931033
- Testing
- Intranasal Oxytocin
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Massachusetts General Hospital
Pulmonary Arterial Hypertension
Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension
The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) <12 years of age.
- Trial name
- FUTURE 3 (NCT01223352)
- Testing
- bosentan
- Volunteers
- 64 people
- Sponsor
- Actelion
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