Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Epilepsy Cysticercosis |
Drug: albendazole Drug: dexamethasone Drug: phenytoin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment |
| Estimated Enrollment: | 120 |
| Study Start Date: | May 2000 |
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| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004403 History of Changes |
| Other Study ID Numbers: | 199/13286, JHUSHPH-FDR001107 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by FDA Office of Orphan Products Development:
|
cysticercosis epilepsy immunologic disorders and infectious disorders neurologic and psychiatric disorders |
parasitic infection rare disease seizures |
Additional relevant MeSH terms:
|
Cysticercosis Taeniasis Neurocysticercosis Epilepsy Cestode Infections Helminthiasis Parasitic Diseases Central Nervous System Helminthiasis Central Nervous System Parasitic Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Brain Diseases Albendazole Phenytoin |
Dexamethasone Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Anticestodal Agents Antiplatyhelmintic Agents Anthelmintics Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on May 23, 2013