Effects of 2 Different Duration of Albendazole Therapy in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT
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
1 other identifier
interventional
97
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 5, 2014
CompletedFirst Posted
Study publicly available on registry
September 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedJanuary 1, 2016
December 1, 2015
1.6 years
May 5, 2014
December 31, 2015
Conditions
Keywords
Outcome Measures
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
1 year
Secondary Outcomes (3)
Frequency of seizure occurrence
1 year
Frequency of occurrence of other symptoms attributable to Neurocysticercosis
1 year
Frequency of occurrence of side effects of albendazole
1 year
Study Arms (2)
Group A
ACTIVE COMPARATOR7 days of albendazole 15 mg/kg/day
Group B
ACTIVE COMPARATOR28 days of albendazole 15 mg/kg/day
Interventions
group A will receive 7 days of oral albendazole 15 mg/kg/day
group B will receive 28 days of oral albendazole 15 mg/kg/day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
sheffali Gulati
New Delhi, National Capital Territory of Delhi, 110029, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheffali Gulati, MD
AIIMS, New Delhi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Additional professor, dept of Pediatrics
Study Record Dates
First Submitted
May 5, 2014
First Posted
September 18, 2014
Study Start
March 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
January 1, 2016
Record last verified: 2015-12