Clinical trials: Open Label
Migraine
Pharmacokinetics & Safety of Cambia® in Migraine With or Without Aura in 12-17 Year Olds
Study Objectives: 1. The primary objective is to characterize the pharmacokinetics of a single oral administration of 50 mg Cambia in pediatric subjects, ages 12-17 years with a diagnosis of episodic migraine with or without…
- Trial name
- NCT02287376
- Testing
- Diclofenac Potassium for Oral Solution
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Depomed
Attention Deficit Hyperactivity Disorder
Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA
This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit the study site over a period of approximately 14 weeks.
- Trial name
- NCT00434213
- Testing
- Daytrana
- Where
- 29 sites in United States
- Volunteers
- 309 people
- Sponsor
- Noven Therapeutics
Onchocerciasis
A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years
The primary purpose of this study is to determine a dose of moxidectin for children 4 to 11 years that is equivalent to an 8 mg dose administered for treatment of onchocerciasis in people 12 years and over.
- Trial name
- NCT03962062
- Testing
- Moxidectin
- Where
- Ghana
- Volunteers
- 36 people
- Sponsor
- Medicines Development for Global Health
FOXG1 Syndrome
Phase 1/2 Study of FRF-001, an AAV-9 Gene Therapy, in Patients With FOXG1 Syndrome (FS)
The goal of this clinical trial is to learn if FRF-001 is a safe, tolerable, and efficacious treatment for children and adults with FOXG1 syndrome.
- Trial name
- NCT07293546
- Testing
- FRF-001
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- FOXG1 Research Foundation
Sturge-Weber Syndrome, Glaucoma
Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
Open-label study of an investigational product (IP), QLS-101, with 28-day every morning (QAM) dosing to both eyes (OU) in adolescents with SWS who have clinical evidence of glaucoma and/or ocular hypertension (OHT) related to SWS…
- Conditions
- Sturge-Weber Syndrome, Glaucoma, Ocular Hypertension
- Trial name
- NCT05495269
- Testing
- QLS-101 ophthalmic solution, 2.0 %
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Qlaris Bio, Inc.
Acute Myeloid Leukemia (AML)
Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With Relapsed/Refractory CBFA2T3::GLIS2 AML
This trial will evaluate whether luveltamab tazevibulin is well tolerated and active against a rare form of AML carrying a particular genetic abnormality called CBFA2T3::GLIS2 that arises in infants and children.
- Trial name
- NCT06679582
- Testing
- Luveltamab tazevibulin
- Where
- 36 sites in United States, Austria and 7 more
- Volunteers
- 1 people
- Sponsor
- Sutro Biopharma, Inc.
Limb Girdle Muscular Dystrophy
A Gene Transfer Single Dose Study to Evaluate the Safety, Tolerability and Efficacy of SRP-9003 in Non-Ambulatory and Ambulatory Participants With Limb Girdle Muscular Dystrophy, Type 2E/R4 (Beta-Sarcoglycan [β-SG] Deficiency)
The primary purpose of this study is to evaluate the safety of SRP-9003 and to quantify expression of β-SG in the skeletal muscle of participants with limb-girdle muscular dystrophy, type 2E/R4 (LGMD2E/R4).
- Trial name
- NCT05876780
- Testing
- SRP-9003
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Sarepta Therapeutics, Inc.
Graft Vs Host Disease
Study Comparing ABX-CBL (Monoclonal Antibody) Versus Atgam in Patients With Steroid Resistant Acute Graft Versus Host Disease
Trial evaluating the improvement in survival at 180 days of two therapies (Atgam versus ABX-CBL, a monoclonal antibody) in patients with acute graft versus host disease that does not respond to steroid therapy.
- Trial name
- NCT00035880
- Testing
- ABX-CBL
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- Abgenix
Depressive Disorder, Major
Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age
Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent participants with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD.
- Trial name
- NCT02871297
- Testing
- Vortioxetine
- Where
- 78 sites in United States, Bulgaria and 18 more
- Volunteers
- 662 people
- Sponsor
- H. Lundbeck A/S
Myocardial Ischemia, Coronary Artery Disease
A Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients
This is a multi-centre, open-label, single-dose safety, tolerability and PK-pharmacodynamics (PD) study of the vasodilator regadenoson in 3 paediatric age groups for whom a pharmacologic stress perfusion CMR test is clinically…
- Trial name
- Rapiscan PIP (NCT04604782)
- Testing
- Regadenoson
- Where
- 5 sites in France, Greece and 2 more
- Volunteers
- 54 people
- Sponsor
- GE Healthcare
Urea Cycle Disorders
Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs)
This non-randomized, open-label study was approximately one year in duration and consisted of a short term NaPBA to HPN-100 switchover part involving two overnight stays followed by a 12-month long term treatment period involving…
- Trial name
- NCT01347073
- Testing
- HPN-100
- Where
- 8 sites in United States
- Volunteers
- 23 people
- Sponsor
- Amgen
Neuroblastoma
Phase 1 Study of BCD-245 in Subjects With Neuroblastoma
The aim of the study is to investigate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-245 after its single and multiple intravenous infusions at escalating doses in subjects with relapsed/refractory…
- Trial name
- NCT05782959
- Testing
- BCD-245
- Where
- 3 sites in Russia
- Volunteers
- 24 people
- Sponsor
- Biocad
Chemotherapy-induced Nausea and Vomiting
Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029)
The purpose of this study was to determine the appropriate dosing regimen of fosaprepitant, when administered with ondansetron (with or without dexamethasone), for the prevention of CINV in children from birth to <17 years of…
- Trial name
- NCT01697579
- Testing
- Fosaprepitant, Ondansetron, 5-hydroxytryptamine 3 antagonist
- Volunteers
- 240 people
- Sponsor
- Merck Sharp & Dohme LLC
Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection
Pharmacokinetic, Efficacy, Safety and Tolerability Study of a Single Dose of Acoziborole in g-HAT Paediatric Patients
Acoziborole has been studied in an open-label pivotal Phase II/III trial (DNDi-OXA-02-HAT) in the DRC and Guinea. As the numbers of reported cases diminish, resources for surveillance and specialised screening will also taper.
- Conditions
- Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection, Sleeping Sickness
- Trial name
- OXA005 (NCT05433350)
- Testing
- Acoziborole
- Where
- 6 sites in Democratic Republic of the Congo, Guinea
- Volunteers
- 35 people
- Sponsor
- Drugs for Neglected Diseases
Duchenne Muscular Dystrophy
Phase IIb Study of PRO045 in Subjects With Duchenne Muscular Dystrophy
The purpose of the study is to see whether PRO045 is safe and effective to use as medication for Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 45 in the DNA for the dystrophin protein.
- Trial name
- NCT01826474
- Testing
- PRO045, 0.15 mg/kg/week, PRO045, 1.0 mg/kg/week, PRO045, 3.0 mg/kg/week
- Where
- 6 sites in Belgium, France and 3 more
- Volunteers
- 15 people
- Sponsor
- BioMarin Pharmaceutical
Migraine
A Trial to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment…
- Trial name
- NCT04530110
- Testing
- Fremanezumab
- Where
- 70 sites in United States, Canada and 7 more
- Volunteers
- 499 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
COVID-19, SARS-CoV-2
Parent Study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA Sub-study)
AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.
- Trial name
- SUPERNOVA (NCT05648110)
- Testing
- AZD5156 (Parent study Sentinel Safety Cohort), EVUSHELD™ (Parent study Main Cohort), AZD3152 (Parent study Main Cohort)
- Where
- 215 sites in United States, Australia and 16 more
- Volunteers
- 3,882 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Infection, Human Immunodeficiency Virus, HIV Infections
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years…
- Trial name
- NCT00071760
- Testing
- GW433908, ritonavir
- Where
- 15 sites in United States, Argentina and 5 more
- Volunteers
- 59 people
- Sponsor
- ViiV Healthcare
Herpes Simplex
Open-label Study of ASP2151 in Herpes Simplex Patients
A multicenter, open-label study is conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (recurrent labial/facial herpes and recurrent genital herpes and Kaposi varicelliform).
- Trial name
- NCT02209324
- Testing
- ASP2151
- Where
- 3 sites in Japan
- Volunteers
- 275 people
- Sponsor
- Maruho Co., Ltd.
AML, Childhood
A Phase 1 Trial of CD33xCD3 BsAb in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia
Pediatric patients (<21 years at study entry) with relapsed or refractory acute myeloid leukemia (AML) will be treated with CD33*CD3 a bispecific antibody to investigate the safety and tolerability of the drug.
- Trial name
- NCT05077423
- Testing
- CD33*CD3 BsAb
- Where
- 13 sites in United States
- Volunteers
- 3 people
- Sponsor
- Y-mAbs Therapeutics
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