Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441285
Status:
COMPLETED
Last Update Posted:
2015-06-11
First Post:
2007-02-27
Brief Title:
Neurocysticercosis Combined Treatment With Praziquantel PZQ and Albendazole ABZ
Sponsor:
Universidad Peruana Cayetano Heredia
Organization:
Universidad Peruana Cayetano Heredia
Study Overview
Official Title:
Antiparasitic Therapy for Neurocysticercosis Phase IIIII Study on Safety and Efficacy of Combined Treatment With Praziquantel and Albendazole
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if combination drug therapy of praziquantel and albendazole is safe and effective to cure neurocysticercosis
Detailed Description:
Neurocysticercosis is the single major cause of acquired or late-onset epilepsy in the world and a common diagnosis in immigrant populations in the United States and other industrialized countries An estimated 50 million humans are affected by Neurocysticercosis The disease occurs when a parasite called Taenia solium or the pig tapeworm infects the brain forming cysts Neurocysticercosis is generally treated with 1 of 2 drugs praziquantel or albendazole However current treatment with either of these drugs alone is not totally effective
The goal of this trial is to determine if combination drug therapy of praziquantel and albendazole is safe and more effective to cure Neurocysticercosis than either drug administered alone This trial will consist of two sub-studies and a parent study
In the first substudy which was performed and completed as the initial part and guide to the design of the parent study a series of 32 patients with viable cystic intraparenchymal Neurocysticercosis were treated with either albendazole 15 mg kg d praziquantel 50 mg kg d or albendazolePlacebo in a double blind randomized study Half of patients in each group had their seizure disorder treated with phenytoin and the other half with carbamazepine not assigned by the study The study was designed and powered for pharmacokinetic evaluation and exploratory safety so comparative cysticidal efficacy has not yet been analyzed There were no safety concerns Pharmacokinetics of ABZ and PZQ were obtained and described
In the parent study a total of 240 participants including the 32 participants from the first substudy will be randomly chosen to receive albendazole praziquantel albendazole placebo or albendazole at an increased dose placebo for 10 days These groups will also receive other standard medications to manage the disease including appropriate anti-epileptic drug therapy Participants will stay in the hospital for at least 2 weeks after treatment begins which includes 5 days after the end of anti-parasitic treatment After discharge from the hospital follow-up visits will be on days 21 and 30 after treatment begins then monthly until day 90 and finally every 3 months until completing 18 months Brain images will be taken at 6 and 12 months after treatment begins For participants duration of the trial is 1 year and a half
The goal of this trial is to determine if combination drug therapy of praziquantel and albendazole is safe and more effective to cure Neurocysticercosis than either drug administered alone This trial will consist of two sub-studies and a parent study
In the first substudy which was performed and completed as the initial part and guide to the design of the parent study a series of 32 patients with viable cystic intraparenchymal Neurocysticercosis were treated with either albendazole 15 mg kg d praziquantel 50 mg kg d or albendazolePlacebo in a double blind randomized study Half of patients in each group had their seizure disorder treated with phenytoin and the other half with carbamazepine not assigned by the study The study was designed and powered for pharmacokinetic evaluation and exploratory safety so comparative cysticidal efficacy has not yet been analyzed There were no safety concerns Pharmacokinetics of ABZ and PZQ were obtained and described
In the parent study a total of 240 participants including the 32 participants from the first substudy will be randomly chosen to receive albendazole praziquantel albendazole placebo or albendazole at an increased dose placebo for 10 days These groups will also receive other standard medications to manage the disease including appropriate anti-epileptic drug therapy Participants will stay in the hospital for at least 2 weeks after treatment begins which includes 5 days after the end of anti-parasitic treatment After discharge from the hospital follow-up visits will be on days 21 and 30 after treatment begins then monthly until day 90 and finally every 3 months until completing 18 months Brain images will be taken at 6 and 12 months after treatment begins For participants duration of the trial is 1 year and a half
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NS054805 | NIH | None | httpsreporternihgovquickSearchR01NS054805 |