Neurocysticercosis Clinical Trial
Official title:
A Randomized, Double-Blind Placebo-Controlled Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole
The objectives of the Phase I study are to evaluate the safety and tolerance of increasing single oral doses of oxfendazole in healthy volunteers.The secondary objectives assess the pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. The description of agent used is single oral dose of an aqueous suspension of oxfendazole, a benzimidazole carbamate antiparasitic drug. Each new cohort will be dosed only after the two week safety data for the preceding group have been reviewed. If a clinically significant AE is observed, and if this event is drug-related the safety monitoring committee will be convened to determine whether the study should continue.
This Phase I study is a randomized, double-blind, placebo-controlled evaluation of the safety and pharmacokinetics of escalating single oral doses of oxfendazole (0.5 to 60 mg/kg) in healthy volunteers. Up to 70 healthy males and females (non-chldbearing potential), ages 18-45 volunteers recruited from one site will participate in this study. The study duration is approximately 18 months with subject participation of 2 weeks. The primary objective assess the safety and tolerability of oxfendazole in healthy adults. The secondary objectives assess the pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. Two sentinel subjects will receive the study product (1 drug/1 placebo) in each group and be monitored 48 hours for adverse events prior to completing enrollment of the remaining 8 subjects in the group. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00527579 -
PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [F-18]FB
|
Phase 1 | |
| Completed |
NCT00526916 -
PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [C-11]PBR28
|
Phase 1 | |
| Terminated |
NCT02233855 -
People Presenting With Neurocysticercosis in North America
|
||
| Recruiting |
NCT00001205 -
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
|
||
| Terminated |
NCT02947581 -
Sub Arachnoid Neurocysticercosis Treatment Outcome (SANTO)
|
Phase 3 | |
| Completed |
NCT02243644 -
Effects of 2 Different Duration of Albendazole Therapy in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT
|
Phase 3 | |
| Not yet recruiting |
NCT06376396 -
Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis
|
Phase 4 | |
| Completed |
NCT03874689 -
Investigation of Environmental Factors Associated With Transmission of T. Solium in Endemic Villages of Zambia
|
||
| Completed |
NCT00441285 -
Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ)
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT04706819 -
Parenchymal and Extraparenchymal Neurocysticercosis-A Registry Based Study
|
||
| Completed |
NCT00283699 -
A Pilot Study of Neurocysticercosis Treatment
|
Phase 3 | |
| Terminated |
NCT02945527 -
Treatment of Peri-calcification Edema in Neurocysticercosis (NCC)
|
Phase 2/Phase 3 | |
| Completed |
NCT00290823 -
Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients
|
Phase 3 | |
| Completed |
NCT03834337 -
Treatment of Patients With Active Neurocysticercosis in Eastern Africa
|
||
| Completed |
NCT03851419 -
The Burden of (Neuro)Cysticercosis Among People Living With HIV in Rural Tanzania
|