Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 9, 2006 | ||||||||
| Last Updated Date | September 25, 2008 | ||||||||
| Start Date ICMJE | July 2007 | ||||||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Cumulative frequency of partial, generalized, and total seizures [ Time Frame: Through Day 42 ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Cumulative frequency of partial, generalized, and total seizures from Days 11 to 42 | ||||||||
| Change History | Complete list of historical versions of study NCT00290823 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Cumulative frequency of generalized seizures [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Cumulative frequency of generalized seizures | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients | ||||||||
| Official Title ICMJE | Treatment of Intraparenchymal Neurocysticercosis: Effect of Increased Dosing of Corticosteroids on Seizure Frequency | ||||||||
| Brief Summary | 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). |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Neurocysticercosis | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 110 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Not Provided | ||||||||
| Location Countries ICMJE | Peru | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00290823 | ||||||||
| Other Study ID Numbers ICMJE | 05IN214, 05-I-N214 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Theodore E. Nash, MD, Gastrointestinal Parasites Section, Laboratory of Parasitic Diseases, NIAID | ||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | September 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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