Clinical trials: Tolerability
Huntington Disease
Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease
WVE-HDSNP2-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120102 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism…
- Trial name
- NCT04617860
- Testing
- WVE-120102
- Where
- 20 sites in Australia, Canada and 5 more
- Volunteers
- 36 people
- Sponsor
- Wave Life Sciences USA, Inc.
Autism Spectrum Disorder, Wearable Devices
ASD Wearables Feasibility Study
The goal of this clinical study is to evaluate and compare the feasibility of wearable device use among pediatric participants with autism spectrum disorder (ASD) across four different wearable device form factors: a wristband…
- Trial name
- ASDW (NCT07504224)
- Testing
- 14-Day Device Monitoring
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Rady Pediatric Genomics & Systems Medicine Institute
Epilepsy, Partial, Motor, Epilepsy, Complex Partial
A Study of the Effectiveness, Safety, and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures.
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of carisbamate as add-on therapy for the treatment of partial onset seizures in patients with epilepsy.
- Conditions
- Epilepsy, Partial, Motor, Epilepsy, Complex Partial, Epilepsy, Simple Partial, Focal Motor Epilepsy
- Trial name
- NCT00740623
- Testing
- Carisbamate
- Volunteers
- 547 people
- Sponsor
- SK Life Science, Inc.
Coronavirus
Recombinant New Coronavirus Vaccine (CHO Cells) to Prevent SARS-CoV-2(COVID-19) Phase I Clinical Trial (3~17 Years Old)
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (3~17 years old) Research purpose:Main purpose:To evaluate the safety and tolerability of recombinant New Coronavirus vaccine (CHO cells) in…
- Trial name
- NCT04961359
- Testing
- Recombinant new coronavirus vaccine (CHO cell) group
- Where
- China
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Hepatitis B Virus (HBV)
Evaluation of Tenofovir Disoproxil Fumarate in Adolescents With Chronic Hepatitis B Infection
The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic hepatitis B virus (HBV) infection.
- Trial name
- NCT00734162
- Testing
- Tenofovir disoproxil fumarate (TDF)
- Where
- 21 sites in United States, Bulgaria and 5 more
- Volunteers
- 106 people
- Sponsor
- Gilead Sciences
Malaria, Vivax, Therapeutics
DHA-PQP vs Chloroquine and Primaquine for Radical Cure of Vivax Malaria in Brazil
Plasmodium vivax can be cause of severe malaria and mortality. There are serious public health implications associated with cases of P.
- Trial name
- CuraVivax (NCT03208907)
- Testing
- CQ coadministered with PQ, DHA-PQP coadministered with PQ, CQ and PQ starting on Day 42
- Where
- Brazil
- Volunteers
- 419 people
- Sponsor
- Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
The objective of this study is to evaluate the safety, tolerability, efficacy profile, and effect on growth and development of vorasidenib in pediatric participants aged 12 to < 18 years old with grade 2 glioma with an IDH1 or…
- Trial name
- NCT07286292
- Testing
- Vorasidenib
- Where
- 5 sites in United States, Australia
- Volunteers
- 10 people
- Sponsor
- Institut de Recherches Internationales Servier (I.R.I.S.)
Microtia
Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia (Australia)
AUR-201 is indicated for the treatment of Grade II, III, or IV unilateral microtia in patients 8 to 29 years of age.
- Trial name
- AUR-201 (NCT06225336)
- Testing
- AUR-201
- Where
- Australia
- Volunteers
- 2 people
- Sponsor
- Auregen Biotherapeutics, SA
KCNT1-Related Epilepsy
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of ABS-1230 in Pediatric and Young Adult Participants With KCNT1-related Epilepsy
This trial will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ABS-1230 compared with placebo in participants with KCNT1-related epilepsy
- Trial name
- KYRON (NCT07600736)
- Testing
- ABS-1230
- Where
- 2 sites in United States
- Volunteers
- 61 people
- Sponsor
- Actio Biosciences, Inc.
Duchenne Muscular Dystrophy (DMD)
A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids
The purpose of the study is to assess the efficacy of idebenone in delaying the loss of respiratory function in patients with DMD receiving concomitant glucocorticoid steroids
- Trial name
- SIDEROS (NCT02814019)
- Testing
- Idebenone 150 mg film-coated tablets
- Where
- 63 sites in United States, Austria and 13 more
- Volunteers
- 255 people
- Sponsor
- Santhera Pharmaceuticals
Tuberculosis, HIV
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
P1108 was a Phase I/II, open-label, single-arm, exposure-controlled dose finding study of BDQ in infants, children, and adolescents living with and without HIV, with clinically diagnosed or bacteriologically confirmed…
- Trial name
- NCT02906007
- Testing
- Bedaquiline
- Where
- 4 sites in Haiti, South Africa
- Volunteers
- 54 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Pediatric Expanded Access Program-Oral Solution (0831-908)
Monitor the safety and tolerability of efavirenz oral solution in combination with Antiretroviral Therapy for the treatment of patients age 3 to 16 years who have failed therapy or who are intolerant to their current therapy.
- Trial name
- NCT00543530
- Testing
- MK0831
- Sponsor
- Merck Sharp & Dohme LLC
Pruritus, Chronic Kidney Diseases
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
Rationale: People with long term kidney disease who are on haemodialysis (a procedure for removing waste products from the blood) commonly develop a condition that makes their skin very itchy.
- Trial name
- NCT06593392
- Testing
- Difelikefalin
- Where
- 18 sites in China, Greece and 5 more
- Volunteers
- 18 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma
Infantile Spasms
Use of the Modified Atkins Diet in Infantile Spasms
Infantile spasms constitute a type of catastrophic epilepsy syndrome occuring in young children. The ketogenic diet has been shown to be very effective in these children.
- Trial name
- ADIS (NCT01006811)
- Testing
- modified Atkins diet
- Where
- India
- Volunteers
- 15 people
- Sponsor
- All India Institute of Medical Sciences
Candidiasis, Candidemia
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection
In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down.
- Trial name
- NCT00739934
- Testing
- voriconazole (Vfend)
- Where
- 14 sites in United States
- Volunteers
- 40 people
- Sponsor
- Pfizer
COVID-19
A 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL
This is a phase 2/3, multicenter, randomized, placebo-controlled, observer-blind study assessing the safety, tolerability, immunogenicity, and efficacy of prophylactic hAd5-S-Fusion+N-ETSD against COVID-19.
- Trial name
- NCT06022224
- Testing
- hAd5-S-Fusion+N-ETSD
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- ImmunityBio, Inc.
Atopic Dermatitis
Open-Label Study of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis
This is a multicenter, open-label Phase 1b study in pediatric patients age 2-11 years old with extensive atopic dermatitis.
- Trial name
- NCT03415282
- Testing
- RVT-501 0.5% topical ointment
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- Dermavant Sciences GmbH
Asthma
Plasma Levels of MK0633 in Children Ages 6-12 (0633-023)
To evaluate the safety, tolerability and plasma levels of single oral doses of MK0633 in pediatric asthma patients ages 6 to less than 12 years.
- Trial name
- NCT00751413
- Testing
- Comparator: MK0633
- Volunteers
- 22 people
- Sponsor
- Merck Sharp & Dohme LLC
SARS-CoV-2
Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants
The study evaluated the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273.214 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in infants aged 12 weeks to < 6 months.
- Trial name
- BabyCOVE (NCT05584202)
- Testing
- mRNA-1273.214
- Where
- 39 sites in United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Neuroendocrine Tumor, Gastrointestinal Neoplasm
A Study of XmAb®18087 in Subjects With NET and GIST
This is a Phase 1, multiple dose, ascending dose escalation study; to define a MTD/RD and regimen consisting of a first "priming" dose and escalated subsequent doses of XmAb18087; to describe safety and tolerability; to assess PK…
- Trial name
- NCT03411915
- Testing
- XmAb18087
- Where
- 16 sites in United States
- Volunteers
- 62 people
- Sponsor
- Xencor, Inc.
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