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

Neurocysticercosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02243644
• Other study ID #: IESC/T-320/02.08.2013
• 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

• Cysticercosis
• Neurocysticercosis

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