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NCT Number: NCT02243644

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

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.

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Key information

Conditions

Neurocysticercosis Central Nervous System Diseases Central Nervous System Helminthiasis Central Nervous System Infections Central Nervous System Parasitic Infections Cestode Infections Cysticercosis Helminthiasis Infections Nervous System Diseases Parasitic Diseases Taeniasis

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

sheffali Gulati

New Delhi, National Capital Territory of Delhi, 110029, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

7 days of albendazole 15 mg/kg/day

Drug

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

Other names: Zentel, Bandy

28 days of albendazole 15 mg/kg/day

Drug

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

Other names: Zentel, Bandy

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. Frequency of seizure occurrence

    Time frame: 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

  2. Frequency of occurrence of other symptoms attributable to Neurocysticercosis

    Time frame: 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

  3. Frequency of occurrence of side effects of albendazole

    Time frame: 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

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 18, 2014
Registry last updated
Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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