Back to resultsTreatment of Peri-calcification Edema in Neurocysticercosis (NCC)
Primary Purpose
Neurocysticercosis
Status
Terminated
Phase
Phase 2
Locations
Peru
Study Type
Interventional
Intervention
Acetazolamide
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Neurocysticercosis
Eligibility Criteria
Inclusion Criteria:
- Calcified NCC
- Perilesional edema on CT or MRI
- Normal lab values
Exclusion Criteria:
- Viable neurocysticercosis
- Status epilepticus
- Symptomatic intracranial hypertension
- Tuberculosis
- More than 7 days after seizure
- Pregnancy
Sites / Locations
- Cysticercosis Unit, Instituto Nacional de Ciencias Neurologicas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Acetazolamide
Dexamethasone
No additional anti-edema treatment
Arm Description
750 mg acetazolamide p.o. divided in three dily doses, for 10 days
8 mg p.o. divided in three daily daily doses, for 2 days followed by gradual tapering
No additional treatment
Outcomes
Primary Outcome Measures
Decrease in Volume of Perilesional Edema Between Baseline and Day 4
MRI extension of edema
Secondary Outcome Measures
Decrease in Volume of Perilesional Edema Between Baseline and Day 8
MRI extension of edema
Decrease in Volume of Perilesional Edema Between Baseline and Day 30
MRI extension of edema
Full Information
NCT ID
NCT02945527
First Posted
May 10, 2016
Last Updated
June 20, 2022
Sponsor
Universidad Peruana Cayetano Heredia
1. Study Identification
Unique Protocol Identification Number
NCT02945527
Brief Title
Treatment of Peri-calcification Edema in Neurocysticercosis (NCC)
Official Title
Open Controled Randomized Pilot Study on the Use of Acetazolamide and Dexamethasone for the Acute Phase of Perilesional Edema in Calcified Neurocysticercosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
December 4, 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Peruana Cayetano Heredia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Three-arm open, randomized comparative study of acetazolamide, dexamethasone, or no additional treatment to evaluate decrease in peri-calcification edema in neurocysticercosis
Detailed Description
This study will evaluate 24 patients with calcified NCC and edema in three treatment arms to compare the reduction in edema volume
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurocysticercosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acetazolamide
Arm Type
Active Comparator
Arm Description
750 mg acetazolamide p.o. divided in three dily doses, for 10 days
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
8 mg p.o. divided in three daily daily doses, for 2 days followed by gradual tapering
Arm Title
No additional anti-edema treatment
Arm Type
No Intervention
Arm Description
No additional treatment
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Intervention Description
As described above
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
As described above
Primary Outcome Measure Information:
Title
Decrease in Volume of Perilesional Edema Between Baseline and Day 4
Description
MRI extension of edema
Time Frame
Baseline to Day 4
Secondary Outcome Measure Information:
Title
Decrease in Volume of Perilesional Edema Between Baseline and Day 8
Description
MRI extension of edema
Time Frame
Baseline to Day 8
Title
Decrease in Volume of Perilesional Edema Between Baseline and Day 30
Description
MRI extension of edema
Time Frame
Baseline to Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Calcified NCC
Perilesional edema on CT or MRI
Normal lab values
Exclusion Criteria:
Viable neurocysticercosis
Status epilepticus
Symptomatic intracranial hypertension
Tuberculosis
More than 7 days after seizure
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hector H. Garcia, MD, PhD
Organizational Affiliation
Universidad Peruana Cayetano Heredia
Official's Role
Study Chair
Facility Information:
Facility Name
Cysticercosis Unit, Instituto Nacional de Ciencias Neurologicas
City
Lima
ZIP/Postal Code
Lima 1
Country
Peru
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
As a concrete product, the clinical trial should provide base data to implement an affordable therapy for edema-related seizures. The data produced will be published in a peer reviewed journal.
Learn more about this trial
Treatment of Peri-calcification Edema in Neurocysticercosis (NCC)
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