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

NCT ID: NCT02243644

Last Updated: 2016-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-10-31

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

Conditions

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Neurocysticercosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

7 days of albendazole 15 mg/kg/day

Group Type ACTIVE_COMPARATOR

7 days of albendazole 15 mg/kg/day

Intervention Type DRUG

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

Group B

28 days of albendazole 15 mg/kg/day

Group Type ACTIVE_COMPARATOR

28 days of albendazole 15 mg/kg/day

Intervention Type DRUG

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

Interventions

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7 days of albendazole 15 mg/kg/day

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

Intervention Type DRUG

28 days of albendazole 15 mg/kg/day

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

Intervention Type DRUG

Other Intervention Names

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Zentel Bandy Zentel Bandy

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Sheffali Gulati

Additional professor, dept of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheffali Gulati, MD

Role: PRINCIPAL_INVESTIGATOR

AIIMS, New Delhi

Locations

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sheffali Gulati

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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IESC/T-320/02.08.2013

Identifier Type: -

Identifier Source: org_study_id

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