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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02243644
Other study ID # IESC/T-320/02.08.2013
Secondary ID
Status Completed
Phase Phase 3
First received May 5, 2014
Last updated December 31, 2015
Start date March 2014
Est. completion date October 2015

Study information

Verified date December 2015
Source All India Institute of Medical Sciences, New Delhi
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Health
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 18 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
7 days of albendazole 15 mg/kg/day
group A will receive 7 days of oral albendazole 15 mg/kg/day
28 days of albendazole 15 mg/kg/day
group B will receive 28 days of oral albendazole 15 mg/kg/day

Locations

Country Name City State
India sheffali Gulati New Delhi Delhi

Sponsors (1)

Lead Sponsor Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 year No
Secondary 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 1 year No
Secondary 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 1 year No
Secondary 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 1 year Yes
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Completed NCT02234570 - Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole Phase 1
Terminated NCT02947581 - Sub Arachnoid Neurocysticercosis Treatment Outcome (SANTO) Phase 3
Not yet recruiting NCT06376396 - Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis Phase 4
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