Clinical trials: Botulism
Botulism
Tolerability and Immunogenicity of a Single 40-ug Dose of rBV A/B for the Production of BabyBIG®
This Phase 2, open-label, uncontrolled study designed to evaluate safety, tolerability, and immunogenicity of a single dose of rBV A/B in healthy participants previously immunized with pentavalent botulinum toxoid (or pentavalent…
- Trial name
- NCT06112834
- Testing
- rBV A/B
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- California Department of Public Health
Healthy
Study to Evaluate Safety and PK of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects
A Phase 1, randomized, double-blind, placebo-controlled dose escalation trial of four dose cohorts of 10 subjects (1: 10mg, 2: 25mg, 3: 50mg, 4: 100mg).
- Trial name
- NCT04171115
- Testing
- G03-52-01
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
Respiratory Failure, Botulism
Treatment of Survivors After Botulism Outbreak
Background. Northern Thailand's biggest botulism outbreak to date occurred on 14 March 2006 and affected 209 people. Of these, 42 developed respiratory failure, and 25 of those who developed respiratory failure were referred to 9…
- Trial name
- NCT00314080
- Testing
- Botulinum AntiToxin, neuro-electrophysiologic study, repetitive nerve stimulation, Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure
- Where
- Thailand
- Volunteers
- 18 people
- Sponsor
- Department of Medical Services Ministry of Public Health of Thailand
Botulism
Phase 3, Randomized, Safety, Lot Consistency and Clinical Benefit Study of Recombinant Botulinum Vaccine A/B
This Phase 3 clinical trial is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B in male and female healthy adults 18 to 55 years of age.
- Trial name
- rBV A/B (NCT01940315)
- Testing
- rBV A/B
- Volunteers
- healthy volunteers welcome
- Sponsor
- DynPort Vaccine Company LLC, A GDIT Company
Botulism
BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients
The purpose of this study is to verify the pediatric dosing recommendations for BAT product in pediatric patients that are treated with BAT product due to a confirmed or suspected case of botulism.
- Trial name
- NCT02051062
- Testing
- Blood sample collection
- Volunteers
- 10 people
- Sponsor
- Emergent BioSolutions
Stroke, Spasticity, Muscle
Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients
Spasticity of stroke patient, a very common complication in clinical practice, affects performance of hand function and gait pattern. It also interferes with quality of life of patients severely.
- Conditions
- Stroke, Spasticity, Muscle, Botulism, Ultrasound
- Trial name
- NCT04550793
- Testing
- Botulinum toxin injection
- Where
- Taiwan
- Volunteers
- 100 people
- Sponsor
- National Taiwan University Hospital
Hailey-Hailey Disease, Darier Disease
Evaluation of the Improvement of Quality of Life of Patients Suffering From Hailey Hailey or Darier Disease After Injections of Botulism Toxin Into Large Folds.
Hailey Hailey and Darier disease are rare genetic dermatoses. Mutations of 2 genes (ATP2C1 or ATP2A2 respectively) are responsible for the diseases.
- Trial name
- ToxHD (NCT02782702)
- Testing
- Botulism Toxin Treatment
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Toulouse
Botulism, Iatrogenic Botulism
Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA
if amifampridine can improve neuromuscular transmission in muscles previously injected with OnabotulinumtoxinA (BTX-A)
- Trial name
- NCT05769478
- Testing
- Amifampridine
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Wake Forest University Health Sciences
Botulism
Phase I, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1632
This is a Phase I, randomized, double-blind, placebo controlled dose escalation trial to evaluate NTM-1632 in three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg).
- Trial name
- NCT02779140
- Testing
- NTM-1632
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Botulism
Phase 1 PK Study of XOMA 3AB
This is a phase I, single-center, placebo-controlled, double-blinded, dose escalation study of anti-botulinum toxin monoclonal antibodies in healthy adult volunteers.
- Trial name
- NCT01357213
- Testing
- XOMA 3AB
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cerebral Palsy, Spastic, Rehabilitation
A Pilot Study of Constraint Induced Movement Therapy in Preschool Cerebral Palsy After Botulism Toxin Injection
To establish a pilot randomized, crossover study on applying 2 constraint-induced movement therapy (CIMT) interventions in children with hemiplegic cerebral palsy after botulinum toxin injection during preschool education.
- Trial name
- NCT04179682
- Testing
- 40-hour constraint-induced movement therapy
- Volunteers
- 6 people
- Sponsor
- Changhua Christian Hospital
Healthy Volunteers
Botulism Antitoxin Effects on Paralysis Induced by Botulinum Neurotoxins in the EDB Muscle
The primary purpose of this study is: 1. To evaluate the model determined by the ability of botulism antitoxin (bivalent, Aventis) to neutralize Botulinum toxin in the Extensor Digitorum Brevis model of muscle paralysis in Stage…
- Trial name
- NCT00636519
- Testing
- Botulism Antitoxin Bivalent (Equine) Types A and B, Botulism Antitoxin Heptavalent (Equine) Types A-G
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Botulism
BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin
The purpose of the Registry was to evaluate patient safety following Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) administration in adult and pediatric patients with a confirmed or suspected exposure to…
- Trial name
- NCT02055183
- Testing
- BAT
- Volunteers
- 162 people
- Sponsor
- Emergent BioSolutions
Botulism
Botulism Outbreak in Thailand (Episode II)
A second botulism outbreak in Northern Thailand was reported in 2006. 192 people were exposed to raw meat and the gut of deer, 83 suffered from diarrhea. Of these 5 developed respiratory failure, 1 impending respiratory failure.
- Trial name
- NCT00348426
- Testing
- Botulinum AntiToxin, neuro-electrophysiologic study, repetitive nerve stimulation, : Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure
- Where
- Thailand
- Volunteers
- 200 people
- Sponsor
- Department of Medical Services Ministry of Public Health of Thailand
Arthritis Multiple Joint
Botulism Toxin Injection as a Treatment for Arthritis of the Basal Thumb Joint
Basal arthritis of the thumb is a common condition with increased prevalence in post-menopausal women, obese persons, and the elderly. Surgical options are varied and efficacious, but not all patients are candidates for surgery.
- Trial name
- NCT01045694
- Testing
- Botulinum Toxin Type A, Steroid - Triamcinolone Acetonide, Lidocaine
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Missouri-Columbia
Botulism; Poisoning
Retrospective Epidemiological Study on Botulism in Intensive Care Units in France
Botulism poisoning is a rare but serious illness. Because of it's low incidence, it is not well known by physicians. Most studies describing botulism date back to the last century and do not take into account recent advances in…
- Trial name
- BotuREA (NCT03658902)
- Where
- France
- Volunteers
- 52 people
- Sponsor
- Centre Hospitalier le Mans
Infant Botulism, Botulism
Study of Human Botulism Immunoglobulin in Infants With Botulism
OBJECTIVES: I. Determine the safety of human botulism immune globulin (BIG) in patients with infant botulism by monitoring side effects (e.g., rash, fever, hypotension, and anaphylaxis). II.
- Trial name
- NCT00004401
- Testing
- botulism immune globulin
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- California Department of Health Services
Botulism
A Study to Evaluate the Safety and Pharmacokinetics of NTM-1633 vs Placebo Administered Intravenously in Healthy Adults
This is a Phase I, single-center, double-blind, placebo-controlled dose escalation trial of three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg).
- Trial name
- NCT03603665
- Testing
- NTM-1633
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Botulism
Study of the Drug B11-FC (Botulism Treatment)
Study of the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of the drug B11-FC with a single application in adults
- Trial name
- NCT06580236
- Testing
- B11-FC, Botulinum neurotoxin type A
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Botulism
Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid
Study rBV A/B-CL-001 is a Phase 2b, 2-part, open-label, uncontrolled study to evaluate safety, tolerability, and immunogenicity of a single dose of recombinant botulinum vaccine A/B (rBV A/B) for the production of BabyBIG in…
- Trial name
- NCT01701999
- Testing
- rBV A/B
- Where
- 2 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- California Department of Public Health