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

A

All India Institute Of Medical Science (AIIMS)

Status and phase

Completed
Phase 3

Conditions

Neurocysticercosis

Treatments

Drug: 28 days of albendazole 15 mg/kg/day
Drug: 7 days of albendazole 15 mg/kg/day

Study type

Interventional

Funder types

Other

Identifiers

NCT02243644
IESC/T-320/02.08.2013

Details and patient eligibility

About

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.

Full 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

Enrollment

97 patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

97 participants in 2 patient groups

Group A
Active Comparator group
Description:
7 days of albendazole 15 mg/kg/day
Treatment:
Drug: 7 days of albendazole 15 mg/kg/day
Group B
Active Comparator group
Description:
28 days of albendazole 15 mg/kg/day
Treatment:
Drug: 28 days of albendazole 15 mg/kg/day

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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