Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis

NCT00004403 | Completed

• 2 other identifiers: 199/13286JHUSHPH-FDR001107
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Epilepsy; Cysticercosis

Keywords

cysticercosis; epilepsy; immunologic disorders and infectious disorders; neurologic and psychiatric disorders; parasitic infection; rare disease; seizures

Interventions

albendazole DRUG

dexamethasone DRUG

phenytoin DRUG

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Epilepsy; Cysticercosis; Immune System Diseases; Communicable Diseases; Neurologic Manifestations; Mental Disorders; Parasitic Diseases; Rare Diseases; Seizures

Interventions

Albendazole; Dexamethasone; Phenytoin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Taeniasis; Cestode Infections; Helminthiasis; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Robert H. Gilman

  Johns Hopkins University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: May 1, 2000
• Study Completion: March 1, 2002
• Last Updated: March 25, 2015

Record last verified: 2001-01