NCT02243644 - Effects of 2 Different Duration of Albendazole Therapy in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT | Crick

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

97

Conditions

Neurocysticercosis

Interventions

7 days of albendazole 15 mg/kg/dayDRUG

group A will receive 7 days of oral albendazole 15 mg/kg/day

28 days of albendazole 15 mg/kg/dayDRUG

group B will receive 28 days of oral albendazole 15 mg/kg/day

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

sheffali Gulati

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 1 year