EpilepsyNCT00004403
Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis
A study testing albendazole, dexamethasone and phenytoin in people with Epilepsy and Cysticercosis, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Epilepsy, Cysticercosis
- What is being tested?
- albendazole, dexamethasone and phenytoin
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Mar 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
About this study
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
- Conditions
- Epilepsy, Cysticercosis
- Being tested
- albendazole, dexamethasone, phenytoin
- Keywords
- cysticercosis, epilepsy, immunologic disorders and infectious disorders, neurologic and psychiatric disorders, parasitic infection, rare disease, seizures
- Medical subject headings
- Epilepsy, Cysticercosis, Immune System Diseases, Communicable Diseases, Neurologic Manifestations, Mental Disorders, Parasitic Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albendazoleDrug
dexamethasoneDrug
phenytoinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startMay 2000
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Investigators
- Robert H. Gilman, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004403
- Sponsor's protocol ID
- 199/13286
- Other IDs
- JHUSHPH-FDR001107
- Status last verified
- Jan 2001
- First submitted
- 18 Oct 1999
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis
- ClinicalTrials.gov ID
- NCT00004403
- Acronym / sponsor ID
- 199/13286
- Conditions
- Epilepsy, Cysticercosis
- Keywords
- cysticercosis, epilepsy, immunologic disorders and infectious disorders, neurologic and psychiatric disorders, parasitic infection, rare disease, seizures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- May 2000
- Study completion
- Mar 2002
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| albendazole | Drug | – |
| dexamethasone | Drug | – |
| phenytoin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H. Gilman study chair
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing albendazole, dexamethasone and phenytoin in people with Epilepsy and Cysticercosis, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.