ClinicalTrials.gg
CompletedNCT00004403Updated Mar 25, 2015

Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis

An interventional study of albendazole and dexamethasone in Epilepsy and Cysticercosis, sponsored by Johns Hopkins University. Completed. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-03-25.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Epilepsy by Johns Hopkins University — 2 open to participants now, 3 under way, none of them phase 3. Epilepsy · Johns Hopkins University.

Enrollment
Largest of 12
120 · median 26
Started
2000
the only one that year
No phase
6 of 16
1 open now
Registered
1st of 16
by date

Among the 16 studies in Epilepsy by Johns Hopkins University, this one has the largest enrollment of the 12 interventional ones that give a count, is the only one that started in 2000, is one of 6 with no phase, and was the 1st registered.

Epilepsy

1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.

This study's enrollment of 120 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Open to participants now

2 of the 16 studies in Epilepsy by Johns Hopkins University are open now, in 1 country. Each count lists the studies.

All 2 open studies →

Where they have run

Who these studies take

Of the 285 Epilepsy studies recruiting now, 113 (40%) set no upper age limit and 149 (52%) stop at 75 or younger; 139 take children under 18; 56 take healthy volunteers.

This study: 16 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →
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02

Study 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.

Read the 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.

Completion date provided represents the completion date of the grant per OOPD records

03

Conditions studied

  • Epilepsy
  • Cysticercosis

Keywords

  • cysticercosis
  • epilepsy
  • immunologic disorders and infectious disorders
  • neurologic and psychiatric disorders
  • parasitic infection
  • rare disease
  • seizures
04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Masking
Double
Enrollment
120 participants

Interventions

06

Study locations

No study locations are listed for this record.

07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2000 and a completion of Mar 2002. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 1999
First posted
Oct 19, 1999
Start
May 2000
Completion
Mar 2002
Last update
Mar 25, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Mar 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00004403
First posted
Oct 19, 1999
Start date
May 2000
Completion
Mar 2002
Last update
Mar 25, 2015

Study contacts

Robert H. Gilman
study chair · Johns Hopkins University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2001. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Albendazole

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