Clinical trials: Safety and Tolerability
- Condition Safety and Tolerability
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Chronic Graft-versus-host-disease
A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)
This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received…
- Trial name
- AGAVE-201 (NCT04710576)
- Testing
- Axatilimab
- Where
- 121 sites in United States, Australia and 14 more
- Volunteers
- 296 people
- Sponsor
- Syndax Pharmaceuticals
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
Malaria
Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children
This study is a single site, randomized, double-blind, placebo-controlled trial. The trial will assess the safety, tolerability, immunogenicity and vaccine efficacy (VE) of PfSPZ Vaccine in Gabonese children that are naturally…
- Trial name
- NCT03521973
- Testing
- PfSPZ Vaccine, Normal Saline
- Where
- Gabon
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Attention Deficit Disorder With Hyperactivity
Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy
This study will assess the safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.
- Trial name
- NCT00151983
- Testing
- Methylphenidate Transdermal System
- Where
- 18 sites in United States
- Volunteers
- 175 people
- Sponsor
- Noven Therapeutics
Centronuclear Myopathy
Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies
There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)/preliminary efficacy of…
- Trial name
- Unite-CNM (NCT04033159)
- Testing
- DYN101
- Where
- 8 sites in Belgium, Denmark and 4 more
- Volunteers
- 14 people
- Sponsor
- Dynacure
Prophylaxis of Avian Influenza
Immunogenicity, Safety and Tolerability of Two Doses of a Pre-pandemic Influenza Vaccine in Participants Aged 6 Months to 17 Years
Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu vaccination
- Trial name
- NCT00537524
- Testing
- H5N1 Influenza Vaccine
- Where
- Finland
- Volunteers
- 471 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Obese Adolescents, Obesity
A Study of XW003 Injection in Chinese Adolescents With Obesity
The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XW003 injection in Chinese adolescents with obesity
- Trial name
- NCT07143227
- Testing
- XW003 injection
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
Healthy Subjects, Pneumococcal Infections
Study Evaluating Pneumococcal Vaccine in Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.
- Trial name
- NCT00205803
- Testing
- 13-Valent Pneumococcal Conjugate Vaccine (13vPnC), 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)
- Where
- United States
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Primary Immune Deficiency
Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases
Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with primary immunodeficiency diseases
- Trial name
- NCT04640142
- Testing
- Newnorm
- Where
- 23 sites in United States, Germany and 5 more
- Volunteers
- 50 people
- Sponsor
- Octapharma
Cystic Fibrosis
Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase
A major factor in the respiratory health of cystic fibrosis (CF) patients is acquisition of chronic Pseudomonas (P.) aeruginosa infections. The infection rate with P.
- Trial name
- NCT03905642
- Testing
- Arikayce™
- Where
- 11 sites in Belgium, Hungary and 5 more
- Volunteers
- 49 people
- Sponsor
- Insmed Incorporated
Gaucher Disease, Type 1, Gaucher Disease, Type 3
Phase 1/2 Study of CAN103 in Subjects With Gaucher Disease
Gaucher disease is a rare lysosomal storage disorder caused by deficient activity of the enzyme acid β-glucosidase, causing glucosylceramide to accumulate within macrophages and leading to hepatosplenomegaly, anemia…
- Trial name
- NCT05447494
- Testing
- Low-dose CAN103, High-dose CAN103
- Where
- China
- Volunteers
- 40 people
- Sponsor
- CANbridge (Suzhou) Bio-pharma Co., Ltd.
Influenza
Trial to Assess Safety, Efficacy, Tolerability and Immunogenicity of Influenza Virus Vaccine, Liquid Formulation (CAIV-T), Administered Concomitantly With a Combination Live, Attenuated, Mumps, Measles, and Rubella Vaccine in Healthy Children Aged 11 - 24 Months
The primary objective of the study was to determine if intranasally administered influenza virus vaccine, CAIV-T), when administered concomitantly with a subcutaneously administered combination live, attenuated mumps, measles…
- Trial name
- NCT00192166
- Testing
- CAIV-T
- Where
- Singapore
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Primary Immunodeficiency (PID)
Subcutaneous Ig NextGen 16% in PID Patients
This study aims to assess the safety, tolerability, efficacy and pharmacokinetics of Ig NextGen 16% in people with antibody deficiency currently being treated with IntragamP.
- Trial name
- NCT00391131
- Testing
- IgNextGen 16%
- Where
- 12 sites in Australia, New Zealand
- Volunteers
- 35 people
- Sponsor
- CSL Limited
Pediatric Hypertension With or Without CKD
Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD
To assess efficacy, safety and tolerability of valsartan when comparing two doses of valsartan in reducing and controlling blood pressure in children with hypertension with or without CKD.
- Trial name
- NCT01617681
- Testing
- VAL489
- Where
- 27 sites in Belgium, Brazil and 7 more
- Volunteers
- 127 people
- Sponsor
- Novartis Pharmaceuticals
Congenital Adrenal Hyperplasia
Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy
This study is an open-label, randomised, titration-blinded, parallel arm, multicenter study to compare twice daily Chronocort® with standard care in participants with Congenital Adrenal Hyperplasia (CAH).
- Trial name
- RESTORE (NCT03532022)
- Testing
- Chronocort®, Standard Care
- Where
- United States
- Sponsor
- Neurocrine UK Limited
Infantile Spasms
A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms
The study consists of cohorts where participants are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each cohort, Sequence A, comprised of participants, who will receive ascending doses of ganaxolone and ascending…
- Trial name
- NCT00441896
- Testing
- Ganaxolone
- Where
- 15 sites in United States
- Volunteers
- 57 people
- Sponsor
- Marinus Pharmaceuticals
Safety and Tolerability of Iloperidone
Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients
Tolerability, undertstanding of the action of the drug in the body, and understanding the effect of the drug in adolescent patients needing treatment with an antipsychotic medication
- Trial name
- NCT01495169
- Testing
- iloperidone (oral tablet)
- Where
- 10 sites in United States
- Volunteers
- 33 people
- Sponsor
- Vanda Pharmaceuticals
Atopic Dermatitis
Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis
This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD.
- Trial name
- NCT03824405
- Testing
- BTX 1204, Vehicle
- Where
- 31 sites in United States, Australia and 1 more
- Volunteers
- 200 people
- Sponsor
- Botanix Pharmaceuticals
Retinitis Pigmentosa (RP), Usher Syndrome Type 2
Study to Evaluate the Long-Term Safety of Ultevursen in Participants With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene
The purpose of this Phase 2 Open-label study is to evaluate the long-term safety and tolerability of Ultevursen administered via intravitreal injection (IVT) in participants with Retinitis Pigmentosa due to mutations in exon 13…
- Conditions
- Retinitis Pigmentosa (RP), Usher Syndrome Type 2, Deaf Blind, Retinal Disease
- Trial name
- CAPELLA (NCT07796646)
- Testing
- No intervention, will not receive any active study intervention, Intravitreal Injection of Ultevursen
- Volunteers
- 81 people
- Sponsor
- Laboratoires Thea
Spinal Muscular Atrophy
An Open-label Safety, Tolerability, and Dose-range Finding Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA)
This objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics of a single dose of nusinersen (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA).
- Trial name
- SMNRx (NCT01494701)
- Testing
- nusinersen
- Where
- 4 sites in United States
- Volunteers
- 28 people
- Sponsor
- Biogen
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