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

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.

Study Overview

• Status: Completed
• Conditions: Neurocysticercosis
• Intervention / Treatment: Drug: 7 days of albendazole 15 mg/kg/day; Drug: 28 days of albendazole 15 mg/kg/day

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 Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110029
      • sheffali Gulati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; 7 days of albendazole 15 mg/kg/day	Drug: 7 days of albendazole 15 mg/kg/day; group A will receive 7 days of oral albendazole 15 mg/kg/day; Other Names: Zentel; Bandy
Active Comparator: Group B; 28 days of albendazole 15 mg/kg/day	Drug: 28 days of albendazole 15 mg/kg/day; group B will receive 28 days of oral albendazole 15 mg/kg/day; Other Names: Zentel; Bandy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi
• Investigators: Principal Investigator: Sheffali Gulati, MD, AIIMS, New Delhi

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 5, 2014
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (Estimate): September 18, 2014

Study Record Updates

• Last Update Posted (Estimate): January 1, 2016
• Last Update Submitted That Met QC Criteria: December 31, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: parenchymal neurocysticercosis upto five lesions
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Parasitic Diseases; Helminthiasis; Cestode Infections; Central Nervous System Helminthiasis; Central Nervous System Parasitic Infections; Cysticercosis; Taeniasis; Neurocysticercosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antiprotozoal Agents; Antiparasitic Agents; Anthelmintics; Antiplatyhelmintic Agents; Anticestodal Agents; Albendazole
• Other Study ID Numbers: IESC/T-320/02.08.2013