Neurocysticercosis Clinical Trial
Official title:
A Clinical Trial to Study the Effects of Two Different Duration of Same Drug Albendazole in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT Scan Head at the End of 6 Months
Comparing the effect of two different duration of same drug albendazole in patients with Neurocysticercosis less than or equal to 5 lesions on CT head at the end of 6 months.
Status | Completed |
Enrollment | 97 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Age 2-18 years. - Number of parenchymal lesions: upto 5* - Stages of cysticerci at which albendazole treatment is effective - Vesicular stage - Colloid vesicular stage - Granular nodular stage Exclusion Criteria: - Cysticercotic encephalitis - Calcified cyst - Hydrocephalus - Intraventricular cyst - Subarachnoid cyst - Ophthalmic Cysticercosis - No of cysts >5 - Known allergy to benzimidazole class of compound which includes anaphylaxis, hypotension, severe skin reactions . - Features of raised ICT (papilloedema, hyperventilation, hypertension, tonic posturing, B/L 6th nerve palsy, features of midline shift on CT/MRI) - Critically sick (respiratory failure, cardiovascular instability) - Already received albendazole or praziquantel or steroid therapy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | sheffali Gulati | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of cyst resolved/ calcified completely after therapy. Resolution or calcification of cyst assessed on CT head at the end of 6 months after starting albendazole | A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load < 5 | 1 year | No |
Secondary | Frequency of seizure occurrence | A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load < 5 | 1 year | No |
Secondary | Frequency of occurrence of other symptoms attributable to Neurocysticercosis | A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load < 5 | 1 year | No |
Secondary | Frequency of occurrence of side effects of albendazole | A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load < 5 | 1 year | Yes |
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