Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis
Information source: FDA Office of Orphan Products Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy; Cysticercosis
Intervention: albendazole (Drug); dexamethasone (Drug); phenytoin (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: FDA Office of Orphan Products Development Official(s) and/or principal investigator(s):
Robert H. Gilman, Study Chair, Affiliation: Johns Hopkins University
Summary
OBJECTIVES: I. Determine the effect of antiparasitic treatment with albendazole on the
severity and duration of epilepsy due to neurocysticercosis.
II. Determine the effect of a short course of albendazole on Taenia solium cysts present in
the brain.
III. Determine the natural regression of cerebral T. solium cysts in patients given placebo
and their response to treatment at the end of the study.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Detailed description:
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to
receive either albendazole and dexamethasone or placebo.
Patients receive phenytoin daily starting on day 1 and continuing until seizure free for 1
year. Albendazole and dexamethasone or placebo only is administered orally once daily on
days 5-15.
Patients are asked to maintain a diary. Patients are followed on day 15 and 30, then every 3
months for 3 years.
Eligibility
Minimum age: 16 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
PROTOCOL ENTRY CRITERIA:
- -Disease Characteristics--
- Presence of Taenia solium infection as demonstrated by serology and head CT Head CT
showing no more than 20 cysts
- At least 2 spontaneous seizures within the last 6 months excluding: Absence seizures
Rolandic seizures Bilateral spike wave patterns compatible with genetic epilepsy
- -Prior/Concurrent Therapy--
- No prior therapy for cysticercosis
- -Patient Characteristics--
- Age: 16 to 65
- Performance status: Not specified
- Hematopoietic: Not specified
- Hepatic: Not specified
- Renal: Not specified
- Neurologic: No focal deficits No motor deficits No cranial nerve lesions History of
epilepsy of less than 5 years in duration No head CT evidence of the following:
Arteriovenous malformations Trauma Cerebral infarcts or hemorrhages No other focal
disease not attributable to cysticercosis No moderate or severe intracranial
hypertension No status epilepticus
- Other: No unstable condition due to systemic disease or cysticercosis Not pregnant
Locations and Contacts
Additional Information
Starting date: May 2000
Last updated: June 23, 2005
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