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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02243644
Enrollment
97
Registered
2014-09-18
Start date
2014-03-31
Completion date
2015-10-31
Last updated
2016-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurocysticercosis

Keywords

parenchymal neurocysticercosis upto five lesions

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

Interventions

DRUG7 days of albendazole 15 mg/kg/day

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

DRUG28 days of albendazole 15 mg/kg/day

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

Sponsors

All India Institute of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 albendazole1 yearA 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

MeasureTime frameDescription
Frequency of seizure occurrence1 yearA 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 Neurocysticercosis1 yearA 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 albendazole1 yearA 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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026