Clinical trials: Tolerability
Spinal Muscular Atrophy
A Study to Assess the Safety and Tolerability of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA).
The primary objective of Part 1 of this study is to assess the safety and tolerability of Nusinersen in participants with SMA who are not eligible to participate in the clinical studies ISIS 396443-CS3B (NCT02193074) or ISIS…
- Trial name
- EMBRACE (NCT02462759)
- Testing
- Nusinersen
- Where
- 7 sites in United States, Germany
- Volunteers
- 21 people
- Sponsor
- Biogen
Invasive Fungal Infection
Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
This study aims to estimate the pharmacokinetics (PK) of posaconazole (POS, MK-5592) intravenous (IV) and powder for oral suspension (PFS) formulations in pediatric participants <2 years of age with invasive fungal infection…
- Trial name
- NCT04665037
- Testing
- Posaconazole IV 6 mg/kg, Posaconazole PFS 6 mg/kg
- Where
- 26 sites in United States, Belgium and 8 more
- Volunteers
- 40 people
- Sponsor
- Merck Sharp & Dohme LLC
Vaccines, Pneumococcal
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccinations…
- Trial name
- NCT00368966
- Testing
- 13-valent Pneumococcal Conjugate Vaccine, 7-valent Pneumococcal Conjugate Vaccine
- Where
- 41 sites in Spain
- Volunteers
- 619 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Primary Sjögren's Syndrome
Study of Pharmacodynamic Effects of VAY736 in Patients With Primary Sjögren's Syndrome
This study consists of three consecutive parts. Part 1 in primary Sjögren's syndrome (pSS) patients (n=2-6) and Part 2 in healthy voluteers (n=3) are feasibility studies to assess if the selected [Zr-89]-rituximab PET/CT method…
- Trial name
- NCT02495129
- Testing
- VAY736 lower dose, VAY736 higher dose
- Sponsor
- Novartis Pharmaceuticals
X-Linked Retinitis Pigmentosa
A Clinical Trial Evaluating the Safety and Efficacy of a Single Subretinal Injection of AGTC-501 in Participants With XLRP
This study will evaluate and compare the safety, efficacy, and tolerability of 2 doses of a recombinant adeno-associated virus vector (AGTC-501/laruparetigene zovaparvovec )) to an untreated control group in male participants…
- Trial name
- NCT04850118
- Testing
- rAAV2tYF-GRK1-hRPGRco, Control
- Where
- 25 sites in United States, Australia and 2 more
- Volunteers
- 85 people
- Sponsor
- Beacon Therapeutics
Microtia
Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia
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 (NCT06072040)
- Testing
- AUR-201
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Auregen Biotherapeutics, SA
Asthma
Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
- Trial name
- NCT03560466
- Testing
- Dupilumab (SAR231893/REGN668), Asthma controller therapies (incl. prednisone/prednisolone), Asthma reliever therapies
- Where
- 81 sites in United States, Argentina and 16 more
- Volunteers
- 378 people
- Sponsor
- Sanofi
Epilepsy, Epilepsy, Focal
A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on treatment of partial onset seizures.
- Conditions
- Epilepsy, Epilepsy, Focal, Seizure Disorder, Complex Partial Seizures
- Trial name
- NCT00425282
- Testing
- RWJ-333369
- Volunteers
- 566 people
- Sponsor
- SK Life Science, Inc.
Acute Lymphoblastic Leukemia
Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and to assess whether this…
- Trial name
- NCT01471782
- Testing
- Blinatumomab
- Where
- 30 sites in United States, Austria and 5 more
- Volunteers
- 93 people
- Sponsor
- Amgen Research (Munich) GmbH
Moderate-to-severe Plaque Psoriasis
Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Psoriasis
Multicenter, non-interventional, cohort study in pediatric patients with moderate to severe plaque-type psoriasis. Retrospective data collection is planned at patients' inclusion.
- Trial name
- SPARROW (NCT06142357)
- Testing
- Secukinumab
- Where
- 16 sites in Russia
- Volunteers
- 199 people
- Sponsor
- Novartis Pharmaceuticals
Cervical Cancer
Immunogenicity and Safety Study of NBP615 in Healthy Female
This was a randomized, double-blind, active-controlled, phase I/II clinical trial to enroll 200 healthy female including 80 healthy adult aged 19 to 26 years and 120 adolescents aged 9 to 13 years.
- Trial name
- NCT04453241
- Testing
- NBP615, Gardasil
- Where
- South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- SK Bioscience Co., Ltd.
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
HIV Infections
Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil plus abacavir (ABC) plus efavirenz (EFV) plus amprenavir (APV) to HIV-infected patients who have failed to respond to previous treatment…
- Trial name
- NCT00002419
- Testing
- Abacavir sulfate, Amprenavir, Efavirenz
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- Gilead Sciences
Encephalitis, Tick-Borne
Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children
The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.
- Trial name
- NCT00311441
- Testing
- Tick-Borne Encephalitis vaccine
- Where
- Germany
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Novartis
Migraine
Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound.
- Trial name
- UBRO PEDS OLE (NCT05127954)
- Testing
- Ubrogepant
- Where
- 113 sites in United States, Puerto Rico
- Volunteers
- 1,200 people
- Sponsor
- AbbVie
Chemotherapy Induced Mucositis, Mouth Pain
A Study to Characterize the Pharmacokinetics and Tolerability of Buprenorphine Patches in Children With Moderate to Severe Mouth Pain
The purpose of this study is to characterize the pharmacokinetics and tolerability of buprenorphine patches in children who require opioid pain relief for moderate to severe mouth pain.
- Trial name
- BUP1501 (NCT00947466)
- Testing
- Buprenorphine
- Where
- 2 sites in Denmark, United Kingdom
- Volunteers
- 25 people
- Sponsor
- Mundipharma Research Limited
Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.
The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.
- Trial name
- NCT06927466
- Testing
- B019
- Where
- 8 sites in China
- Volunteers
- 33 people
- Sponsor
- Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.
ADHD, Predominantly Inattentive Type
Safety and Tolerability Study of Metadoxine Extended Release (MDX) (Previously Known as MG01CI) in PI-ADHD Adolescent Subjects
The purpose of this study is to evaluate the safety and tolerability of a single administration of Metadoxine Extended Release (MDX) formulation for the treatment of adolescents diagnosed with ADHD that have predominantly…
- Trial name
- NCT02189772
- Testing
- Metadoxine extended release
- Where
- 6 sites in Israel
- Volunteers
- 83 people
- Sponsor
- Alcobra Ltd.
Attention-deficit Hyperactivity Disorder
A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder
This is a phase 1b, multicenter, open-label, multiple-dose trial in pediatric subjects (4 - 12 years of age, inclusive) with a confirmed diagnosis of ADHD.
- Trial name
- NCT04786730
- Testing
- Centanafadine
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Acne Vulgaris
Evaluation of the Effectiveness, Safety, and Tolerability of Duac Akne Gel and Epiduo Gel in the Treatment of Facial Acne Vulgaris
The purpose of this study is to compare the effectiveness of two marketed products in subjects with facial acne vulgaris
- Trial name
- NCT00757523
- Testing
- Epiduo Gel, Duac Gel
- Where
- 17 sites in Germany
- Volunteers
- 382 people
- Sponsor
- Stiefel, a GSK Company
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