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

Phase 3

Completed

• Conditions: Neurocysticercosis
• Interventions: Drug: 28 days of albendazole 15 mg/kg/day; Drug: 7 days of albendazole 15 mg/kg/day

• Registration Number: NCT02243644
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

Brief Summary

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

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-18
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-31
• Last Update Posted: 2016-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	28 days of albendazole 15 mg/kg/day	28 days of albendazole 15 mg/kg/day
Group A	7 days of albendazole 15 mg/kg/day	7 days of albendazole 15 mg/kg/day

Primary Outcome Measures

Name	Time	Method
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	1 year	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

Secondary Outcome Measures

Name	Time	Method
Frequency of seizure occurrence	1 year	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
Frequency of occurrence of other symptoms attributable to Neurocysticercosis	1 year	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
Frequency of occurrence of side effects of albendazole	1 year	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

Trial Locations

Locations (1)

sheffali Gulati; 🇮🇳 New Delhi, Delhi, India