14 completed, 2 unknown, 1 enrolling by invitation, 1 recruiting. 6 Phase 1, 5 Phase 2, 3 Phase 3, 1 Not applicable, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 5, Unknown 1 |
| Phase 2 | 5 | Completed 4, Unknown 1 |
| Phase 3 | 3 | Completed 1, Recruiting 1, Withdrawn 1 |
| Not applicable | 1 | Completed 1 |
| Phase 4 | 1 | Enrolling by invitation 1 |
Follow Botulism: new trials by email Literature Review of Botulism trials Research Report on Botulism
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of the Drug B11-FC (Botulism Treatment) B11-FC, Botulinum neurotoxin type A, Placebo - Botulism | Phase 1 / Phase 2 | Unknown | Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation | 40 | 2024-08-01 | 2024-08-30 |
| Tolerability and Immunogenicity of a Single 40-ug Dose of rBV A/B for the Production of BabyBIG® rBV A/B - Botulism | Phase 2 | Completed | California Department of Public Health | 25 | 2024-07-09 | 2026-07-30 |
| Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA Amifampridine - Botulism, Iatrogenic Botulism | Phase 1 | Completed | Wake Forest University Health Sciences | 21 | 2023-09-15 | 2025-02-03 |
| Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis Botulinum toxin, Standard-of-care corticosteroid injections - Carpometacarpal Sprain, Thumb Sprain | Phase 3 | Recruiting | Rhode Island Hospital | 50 | 2023-08-27 | 2024-11-20 |
| Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients Botulinum toxin injection - Stroke, Spasticity, Muscle | Unknown | National Taiwan University Hospital | 100 | 2020-09-01 | 2020-09-16 | |
| Study to Evaluate Safety and PK of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects G03-52-01, Placebo - Healthy | Phase 1 | Completed | Alachua Government Services, Inc. | 40 | 2020-06-01 | 2024-10-04 |
| Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG® rBV A/B - Botulism | Phase 2 | Completed | California Department of Public Health | 32 | 2019-03-07 | 2021-10-19 |
| A Study to Evaluate the Safety and Pharmacokinetics of NTM-1633 vs Placebo Administered Intravenously in Healthy Adults NTM-1633, Placebo - Botulism | Phase 1 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 24 | 2018-09-25 | 2022-06-22 |
| Phase 3, Randomized, Safety, Lot Consistency and Clinical Benefit Study of Recombinant Botulinum Vaccine A/B rBV A/B, Placebo (USP sterile saline for injection) - Botulism | Phase 3 | Withdrawn | DynPort Vaccine Company LLC, A GDIT Company | 2017-10-01 | 2018-12-04 | |
| Phase I, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1632 NTM-1632, Placebo - Botulism | Phase 1 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 24 | 2016-08-01 | 2018-10-29 |
| BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin BAT - Botulism | Completed | Emergent BioSolutions | 162 | 2014-10-01 | 2024-03-15 | |
| BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients Blood sample collection - Botulism | Phase 4 | Enrolling by invitation | Emergent BioSolutions | 10 | 2014-10-01 | 2026-01-16 |
| Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid rBV A/B - Botulism | Phase 2 | Completed | California Department of Public Health | 45 | 2013-02-01 | 2017-05-16 |
| Pilot Study on the Usefulness of 3,4-diaminopyridine in the Treatment of Botulism 3,4-diaminopyridine - Botulism | Phase 2 / Phase 3 | Completed | Centre Hospitalier Universitaire, Amiens | 3 | 2011-09-01 | 2025-09-19 |
| Phase 1 PK Study of XOMA 3AB XOMA 3AB, Placebo - Botulism | Phase 1 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 24 | 2011-05-01 | 2014-12-05 |
| Botulism Outbreak in Thailand (Episode II) Botulinum AntiToxin, neuro-electrophysiologic study, repetitive nerve stimulation, : Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure - Botulism | Completed | Department of Medical Services Ministry of Public Health of Thailand | 200 | 2006-06-01 | 2006-11-08 | |
| Treatment of Survivors After Botulism Outbreak Botulinum AntiToxin, neuro-electrophysiologic study, repetitive nerve stimulation, Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure - Respiratory Failure, Botulism | Completed | Department of Medical Services Ministry of Public Health of Thailand | 18 | 2006-03-01 | 2008-10-24 | |
| Retrospective Epidemiological Study on Botulism in Intensive Care Units in France Botulism; Poisoning | Completed | Centre Hospitalier le Mans | 52 | 2000-01-01 | 2026-07-01 | |
| Study of Human Botulism Immunoglobulin in Infants With Botulism botulism immune globulin - Infant Botulism, Botulism | Not applicable | Completed | California Department of Health Services | 120 | 1998-01-01 | 2015-03-25 |
Bacterial Infections (1) · Clostridium Infections (1) · Communicable Diseases (1) · Immune System Diseases (1) · Muscle Spasticity (1) · Poisoning (1) · Rare Diseases (1) · Respiratory Insufficiency (1) · Stroke (1)
Bacterial Infections and Mycoses (19) · Chemically-Induced Disorders (19) · Foodborne Diseases (19) · Gram-Positive Bacterial Infections (19) · Infections (19) · Nervous System Diseases (19) · Neuromuscular Diseases (19) · Neuromuscular Junction Diseases (19) · Neurotoxicity Syndromes (19) · Bacterial Infections (18) · Clostridium Infections (18) · Poisoning (18) · Pathological Conditions, Signs and Symptoms (2) · Brain Diseases (1) · Cardiovascular Diseases (1)
Botulinum Antitoxin (3) · Amifampridine (2) · Botulinum Toxins (2) · Botulinum Toxins, Type A (2) · Injections (1) · botulism immune globulin (1)
California Department of Public Health (3) · National Institute of Allergy and Infectious Diseases (NIAID) (3) · Department of Medical Services Ministry of Public Health of Thailand (2) · Emergent BioSolutions (2) · Alachua Government Services, Inc. (1) · California Department of Health Services (1) · Centre Hospitalier Universitaire, Amiens (1) · Centre Hospitalier le Mans (1) · DynPort Vaccine Company LLC, A GDIT Company (1) · Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation (1) · National Taiwan University Hospital (1) · Rhode Island Hospital (1) · Wake Forest University Health Sciences (1)
United States (10) · France (2) · Thailand (2) · Taiwan (1)
Subsai Kongsaengdao, M.D. (2) · Cassandra Key, MD (1) · Christophe Guitton, MD (1) · George A Saviolakis, M.D., Ph.D. (1) · Huey-Wen Liang, MD PHD (1) · James B Caress, MD (1) · Jason S Richardson, Ph.D. (1) · Stephen Arnon, M.D., M.P.H. (1) · Stephen S. Arnon (1) · Stephen S. Arnon, M.D. (1)
PMID 17051488, PMID 24007658, PMID 29475762, PMID 31209461, PMID 33875433