Back to resultsEffects of 2 Different Duration of Albendazole Therapy in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT
Primary Purpose
Neurocysticercosis
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
7 days of albendazole 15 mg/kg/day
28 days of albendazole 15 mg/kg/day
Sponsored by
About this trial
This is an interventional treatment trial for Neurocysticercosis focused on measuring parenchymal neurocysticercosis upto five lesions
Eligibility Criteria
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
Sites / Locations
- sheffali Gulati
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
7 days of albendazole 15 mg/kg/day
28 days of albendazole 15 mg/kg/day
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT02243644
First Posted
May 5, 2014
Last Updated
December 31, 2015
Sponsor
All India Institute of Medical Sciences, New Delhi
1. Study Identification
Unique Protocol Identification Number
NCT02243644
Brief Title
Effects of 2 Different Duration of Albendazole Therapy in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurocysticercosis
Keywords
parenchymal neurocysticercosis upto five lesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
7 days of albendazole 15 mg/kg/day
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
28 days of albendazole 15 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
7 days of albendazole 15 mg/kg/day
Other Intervention Name(s)
Zentel, Bandy
Intervention Description
group A will receive 7 days of oral albendazole 15 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
28 days of albendazole 15 mg/kg/day
Other Intervention Name(s)
Zentel, Bandy
Intervention Description
group B will receive 28 days of oral albendazole 15 mg/kg/day
Primary Outcome Measure Information:
Title
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
Description
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 Outcome Measure Information:
Title
Frequency of seizure occurrence
Description
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
Title
Frequency of occurrence of other symptoms attributable to Neurocysticercosis
Description
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
Title
Frequency of occurrence of side effects of albendazole
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheffali Gulati, MD
Organizational Affiliation
AIIMS, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
sheffali Gulati
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
12. IPD Sharing Statement
Learn more about this trial
Effects of 2 Different Duration of Albendazole Therapy in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT
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