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CompletedNCT02243644Updated Jan 1, 2016

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

A Phase 3 interventional study of 7 days of albendazole 15 mg/kg/day and 28 days of albendazole 15 mg/kg/day in Neurocysticercosis, sponsored by All India Institute of Medical Sciences, New Delhi. Completed at 1 site in India. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-01-01.

Sponsored by All India Institute of Medical Sciences, New Delhi · Phase 3, Interventional, and Treatment

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Phase
Phase 3
Study type
Interventional
Enrollment
97
Allocation
Randomized
Ages
2 Years to 18 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Neurocysticercosis

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Keywords

  • parenchymal neurocysticercosis upto five lesions
03

In context

Neurocysticercosis

21 studies on the registry are indexed under Neurocysticercosis; 5 are open to participants now.

This study's enrollment of 97 is close to the median of 107 across 13 interventional studies indexed under Neurocysticercosis.

Browse Neurocysticercosis studies →

Lead sponsor

All India Institute of Medical Sciences, New Delhi is the lead sponsor of 143 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 therapy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
97 participants (actual)

Study arms

  • Active comparator
    Group A

    7 days of albendazole 15 mg/kg/day

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

  • Active comparator
    Group B

    28 days of albendazole 15 mg/kg/day

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

Interventions

  • Drug7 days of albendazole 15 mg/kg/day

    Drug page: Albendazole

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

    Also known as: Zentel, Bandy

  • Drug28 days of albendazole 15 mg/kg/day

    Drug page: Albendazole

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

    Also known as: Zentel, Bandy

06

What researchers measure

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

    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

    Time frame: 1 year

Secondary outcomes

  1. 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

    Time frame: 1 year

  2. 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

    Time frame: 1 year

  3. 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

    Time frame: 1 year

07

Study locations

1 site
  • sheffali Gulati
    New Delhi, Delhi 110029, India
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2014, a primary completion of Oct 2015 and a completion of Oct 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 5, 2014
First posted
Sep 18, 2014
Start
Mar 2014
Primary completionActual
Oct 2015
CompletionActual
Oct 2015
Last update
Jan 1, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02243644
Responsible party
Sheffali Gulati (Additional professor, dept of Pediatrics, All India Institute of Medical Sciences, New Delhi) — Principal investigator
First posted
Sep 18, 2014
Start date
Mar 2014
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Jan 1, 2016

Study contacts

Sheffali Gulati, MD
principal investigator · AIIMS, New Delhi

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Albendazole

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