Effects of 2 Different Duration of Albendazole Therapy in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT

Study Overview
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Brief Summary
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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.

Detailed Description
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The trial will be comparing the effectiveness of short and long duration of albendazole ie 7 and 28 days therapy in patients with parenchymal neurocysticercosis in terms of complete resolution or calcification of cyst on CT head at the end of 6 months after starting albendazole

Official Title
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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

Conditions
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Neurocysticercosis

Intervention / Treatment
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* Drug: 7 days of albendazole 15 mg/kg/day
* Drug: 28 days of albendazole 15 mg/kg/day


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>7 days of albendazole 15 mg/kg/day | Drug: 7 days of albendazole 15 mg/kg/day<br>* group A will receive 7 days of oral albendazole 15 mg/kg/day<br>* Other names: Bandy;|
| Active Comparator: Group B<br>28 days of albendazole 15 mg/kg/day | Drug: 28 days of albendazole 15 mg/kg/day<br>* group B will receive 28 days of oral albendazole 15 mg/kg/day<br>* Other names: Bandy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parenchymal neurocysticercosis upto five lesions