Clinical trials: Tolerability
Muscular Atrophy, Spinal
Investigate Safety, Tolerability, PK, PD and Efficacy of Risdiplam (RO7034067) in Infants With Type1 Spinal Muscular Atrophy
Open-label, multi-center clinical study is to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and efficacy of Risdiplam (RO7034067) in infants with Type 1 spinal muscular atrophy (SMA).
- Trial name
- FIREFISH (NCT02913482)
- Testing
- Risdiplam
- Where
- 32 sites in United States, Belgium and 14 more
- Volunteers
- 62 people
- Sponsor
- Hoffmann-La Roche
High-risk Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (CMML)
A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias
Study CBX-250-001 is a Phase 1, open-label, dose-escalation study of CBX-250 in participants with relapsed/refractory AML, HR-MDS, CMML, and CML. Participants aged ≥ 12 years are planned to be enrolled.
- Conditions
- High-risk Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (CMML), AML - Acute Myeloid Leukemia, Chronic Myeloid Leukemia
- Trial name
- CROSSCHECK-001 (NCT06994676)
- Testing
- CBX-250
- Where
- 11 sites in United States
- Volunteers
- 72 people
- Sponsor
- Crossbow Therapeutics, Inc.
Cystic Fibrosis
Safety, Tolerability and Pharmacokinetics of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis (CF) Patients
Safety, tolerability and pharmacokinetics following repeated doses (15-day dosing)
- Trial name
- NCT02269189
- Testing
- BIIL 284 BS, high dose, BIIL 284 BS, low dose
- Volunteers
- 36 people
- Sponsor
- Boehringer Ingelheim
Hepatitis B, Chronic
A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection
The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied
- Trial name
- NCT00423891
- Testing
- Entecavir
- Where
- 19 sites in United States, Argentina and 6 more
- Volunteers
- 64 people
- Sponsor
- Bristol-Myers Squibb
SARS-CoV-2 Infection, COVID-19
A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people.
- Trial name
- NCT05997290
- Testing
- BNT162b2 (Omi XBB.1.5), BNT162b2 (Omi JN.1), BNT162b2 (Omi KP.2)
- Where
- 37 sites in United States
- Volunteers
- 1,051 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Schizophrenia, Bipolar I Disorder
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1)
This study is an open label, sequential-group, two site, multiple dose escalating study of sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I disorder; in one study cohort (3a)…
- Trial name
- NCT01206517
- Testing
- Asenapine 2.5 mg, Asenapine 5 mg, Asenapine 10 mg
- Volunteers
- 30 people
- Sponsor
- Organon and Co
Hidradenitis Suppurativa
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).
- Trial name
- RECHARGE-2 (NCT06840392)
- Testing
- Remibrutinib Dose A, Remibrutinib Dose B
- Where
- 129 sites in United States, Argentina and 17 more
- Volunteers
- 565 people
- Sponsor
- Novartis Pharmaceuticals
Overactive Bladder
Extension Study of Fesoterodine for Overactive Bladder Syndrome in Children.
The purpose of this study is to evaluate the long term tolerability of Fesoterodine and its efficacy for overactive bladder syndrome in children.
- Trial name
- FOXY2015 (NCT02614482)
- Testing
- Fesoterodine
- Where
- Canada
- Volunteers
- 26 people
- Sponsor
- Stéphane Bolduc
Meningococcal Disease
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine
The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of this extension study will be to explore antibody persistence at approximately 40 months of age and to evaluate the safety, tolerability…
- Trial name
- NCT01027351
- Testing
- Meningococcal (group B) multicomponent recombinant adsorbed vaccine., Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)
- Where
- United Kingdom
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Inherited Retinal Dystrophy Associated With RPE65 Mutations
Safety and Tolerability of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations
The purpose of the study is to evaluate the safety, tolerability and efficacy of LX101 in subjects with biallelic RPE65 mutation-associated inherited retinal dystrophy.
- Trial name
- NCT06196827
- Testing
- LX101
- Where
- 2 sites in China
- Volunteers
- 9 people
- Sponsor
- Innostellar Biotherapeutics Co.,Ltd
Migraine
Safety and Tolerability of Frovatriptan to Prevention of Menstrually Associated Migraine (MAM) Headaches
In this open-label, multi-center study, patients were treated with frovatriptan for a maximum of 12 perimenstrual periods (PMPs).
- Trial name
- MAM (NCT01035983)
- Testing
- Frovatriptan 2.5 mg
- Where
- 5 sites in Germany, Hungary and 3 more
- Volunteers
- 550 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Congenital Adrenal Hyperplasia
Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperplasia
This phase III study is an open-label extension study to be conducted at approximately 21 investigational sites across 3 countries.
- Trial name
- NCT05299554
- Testing
- Chronocort
- Where
- 21 sites in United States, France and 1 more
- Volunteers
- 76 people
- Sponsor
- Immedica Pharma AB
Spinal Muscular Atrophy
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy (SMA)
The primary objective is to examine the clinical efficacy of multiple doses of nusinersen (ISIS 396443) administered intrathecally to participants with Infantile-Onset Spinal Muscular Atrophy (SMA).
- Trial name
- NCT01839656
- Testing
- nusinersen
- Where
- 4 sites in United States, Canada
- Volunteers
- 21 people
- Sponsor
- Biogen
Systemic Lupus Erythematosus
A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
- Trial name
- NCT04976322
- Testing
- Dapirolizumab pegol
- Where
- 123 sites in United States, Argentina and 22 more
- Volunteers
- 760 people
- Sponsor
- UCB Biopharma SRL
Cervical Cancers, Vulvar Cancer
A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)
This study will evaluate the immunogenicity and tolerability of V503 (a multivalent human papillomavirus [HPV] L1 virus-like particle [VLP] vaccine) in preadolescent and adolescent participants between 9 and 15 years old and…
- Conditions
- Cervical Cancers, Vulvar Cancer, Vaginal Cancer, Genital Lesions
- Trial name
- NCT00943722
- Testing
- V503
- Volunteers
- 3,074 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease
The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis.
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Secondary Hyperparathyroidism
- Trial name
- NCT01290029
- Testing
- Cinacalcet
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 14 people
- Sponsor
- Amgen
CAH - Congenital Adrenal Hyperplasia
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal Hyperplasia
This is a Phase 2, open-label, multiple-dose, study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 (crinecerfont) in pediatric participants (14 to 17 years of age) with a…
- Trial name
- NCT04045145
- Testing
- Crinecerfont
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Neurocrine Biosciences
Duchenne Muscular Dystrophy
AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)
RGX-202 is a gene therapy designed to deliver a transgene for a novel microdystrophin that includes functional elements of naturally-occurring dystrophin including the C-Terminal (CT) domain.
- Trial name
- NCT05693142
- Testing
- RGX-202
- Where
- 23 sites in United States, Canada
- Volunteers
- 65 people
- Sponsor
- REGENXBIO Inc.
Measles, Mumps
Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)
This study will compare the safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with those of the 2006 process
- Conditions
- Measles, Mumps, Rubella, Varicella
- Trial name
- NCT01536405
- Testing
- MMRV (AMP), MMRV (2006 process)
- Volunteers
- 1,412 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Pain
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours.
- Trial name
- NCT00765856
- Testing
- Oxymorphone ER
- Where
- 13 sites in United States
- Volunteers
- 27 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
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