Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients
Recruitment status was Recruiting
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Purpose
The purpose of this study is to determine whether a short course of increased corticosteroid dosing with tapered dosing decreases seizure frequency as compared to standard corticosteroid dosing in patients with neurocysticercosis (NCC).
| Condition | Intervention | Phase |
|---|---|---|
|
Neurocysticercosis |
Drug: Albendazole Drug: Dexamethasone Drug: Omeprazole |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Intraparenchymal Neurocysticercosis: Effect of Increased Dosing of Corticosteroids on Seizure Frequency |
- Cumulative frequency of partial, generalized, and total seizures [ Time Frame: Through Day 42 ] [ Designated as safety issue: Yes ]
- Cumulative frequency of generalized seizures [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 110 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive 6 mg dexamethasone daily for 10 days Participants will also receive albendazole and omeprazole.
|
Drug: Albendazole
400 mg tablet taken orally twice daily
Drug: Dexamethasone
6mg or 8mg taken daily
Drug: Omeprazole
20 mg tablet taken orally daily
|
|
Experimental: 2
Participants will receive 6 mg dexamethasone daily for 10 days, then 8 mg dexamethasone daily for 4 weeks with a 2-week taper. Participants will also receive albendazole and omeprazole.
|
Drug: Albendazole
400 mg tablet taken orally twice daily
Drug: Dexamethasone
6mg or 8mg taken daily
Drug: Omeprazole
20 mg tablet taken orally daily
|
Detailed Description:
NCC is the most common parasitic infection of the central nervous system (CNS). It is caused by ingestion of eggs from a tapeworm of genus Taenia. Inflammation, seizures, or neurologic problems may occur in a patient with NCC. Corticosteroids are the current standard of care for NCC patients, but corticosteroids have many side effects. Albendazole is used to treat infections caused by worms; however, it is unclear if its use with the corticosteroid dexamethasone will decrease seizure frequency in NCC patients. The purpose of this study is to evaluate the efficacy of reducing seizure frequency with a short course of dexamethasone with tapered dosing when given with albendazole, as compared to standard dexamethasone and albendazole treatment, in NCC patients.
In this open label study, patients will be randomly assigned to one of two arms. Group I will receive 6 mg dexamethasone daily for 10 days only. Group II will receive 6 mg dexamethasone daily for 10 days, then 8 mg dexamethasone daily for 4 weeks with a 2-week taper. Both groups will also receive albendazole and omeprazole (a medicine that helps prevent gastroesophageal disease [GERD], a side effect of corticosteroid use). There will be 13 study visits over a 360-day period. Blood collection will occur at most visits. Group II will also undergo sputum smears and rapid culture testing on Days 14, 28, and 42. Patients will undergo magnetic resonance imaging (MRI) at screening and on Day 180 and computed tomography (CT) scanning on Day 360.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with intraparenchymal NCC with 20 or fewer active cysts, as confirmed by enzyme-linked immunoelectrotransfer blot (EITB)
- Diagnosed with epilepsy secondary to NCC, with history of one or more spontaneous seizures within the 6 months prior to study entry
- Willingness to be hospitalized for a minimum of 2 weeks for this study
- PPD negative OR negative smears for tuberculosis (TB) if PPD positive
- Willing to use acceptable forms of contraception during the study and for at least 1 month after albendazole therapy
Exclusion Criteria:
- Primary generalized seizures not caused by NCC
- Subarachnoid or ventricular NCC
- Any vesicular lesion greater than 2 cm in diameter
- Previous therapy with albendazole or praziquantel within 2 years of study entry. Patients who have previously received single-dose albendazole for intestinal parasites are not excluded.
- Intracranial hypertension, as confirmed by CT or MRI
- History of status epilepticus
- Focal neurological defects
- Unstable or consistently abnormal vital signs (e.g., body temperature, pulse, respiratory rate, blood pressure)
- Cysts in critical regions, including brainstem or the eyes
- Pulmonary TB
- History of TB in the patient or history of TB in close contact of patient
- Chest x-ray suggestive of past or current TB
- Diabetes
- Systemic conditions (e.g., chronic kidney failure, liver disease, heart failure, steroid-dependent immune diseases) other than NCC that may interfere with the study
- Predicted survival time of less than 1 year
- Inability to undergo CT or MRI
- Hypersensitivity to albendazole, antiepileptic drugs, or contrast
- Hypertension at rest
- Require corticosteroids, received corticosteroids in the 4 weeks prior to study entry, or received corticosteroids for 9 or more days within the 6 months prior to study entry
- Other CNS processes that may interfere with study assessments
- Pregnancy or breastfeeding
Contacts and Locations| Peru | |
| Instituto Especializado en Ciencias Neurologicas | Recruiting |
| Lima, Peru | |
| Contact: Hector H. Garcia, MD, PhD +511 3287360 hgarcia@jhsph.edu | |
| Principal Investigator: Theodore E. Nash, MD | |
| Principal Investigator: Hector H. Garcia, MD, PhD | |
| Principal Investigator: | Theodore E. Nash, MD | Gastrointestinal Parasites Section, Laboratory of Parasitic Diseases, NIAID |
| Study Director: | Hector H. Garcia, MD, PhD | Department of Microbiology, Universidad Peruana Cayetano Heredia |
More Information
Publications:
| Responsible Party: | Theodore E. Nash, MD, Gastrointestinal Parasites Section, Laboratory of Parasitic Diseases, NIAID |
| ClinicalTrials.gov Identifier: | NCT00290823 History of Changes |
| Obsolete Identifiers: | NCT00344396 |
| Other Study ID Numbers: | 05IN214, 05-I-N214 |
| Study First Received: | February 9, 2006 |
| Last Updated: | September 25, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Taenia Seizures Tapeworm Parasite |
Additional relevant MeSH terms:
|
Seizures Neurocysticercosis Cysticercosis Taeniasis Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Central Nervous System Helminthiasis Central Nervous System Parasitic Infections Parasitic Diseases Cestode Infections Helminthiasis |
Central Nervous System Infections Albendazole Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Omeprazole BB 1101 Anticestodal Agents Antiplatyhelmintic Agents Anthelmintics Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents |
ClinicalTrials.gov processed this record on May 23, 2013