Study Stopped
Low recruitment
Treatment of Peri-calcification Edema in Neurocysticercosis (NCC)
Open Controled Randomized Pilot Study on the Use of Acetazolamide and Dexamethasone for the Acute Phase of Perilesional Edema in Calcified Neurocysticercosis
1 other identifier
interventional
4
1 country
1
Brief Summary
Three-arm open, randomized comparative study of acetazolamide, dexamethasone, or no additional treatment to evaluate decrease in peri-calcification edema in neurocysticercosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2015
Typical duration for phase_2
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
December 4, 2015
CompletedFirst Submitted
Initial submission to the registry
May 10, 2016
CompletedFirst Posted
Study publicly available on registry
October 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedApril 1, 2025
March 1, 2025
3 years
May 10, 2016
March 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Decrease in Volume of Perilesional Edema Between Baseline and Day 4
MRI extension of edema
Baseline to Day 4
Secondary Outcomes (2)
Decrease in Volume of Perilesional Edema Between Baseline and Day 8
Baseline to Day 8
Decrease in Volume of Perilesional Edema Between Baseline and Day 30
Baseline to Day 30
Study Arms (3)
Acetazolamide
ACTIVE COMPARATOR750 mg acetazolamide p.o. divided in three dily doses, for 10 days
Dexamethasone
ACTIVE COMPARATOR8 mg p.o. divided in three daily daily doses, for 2 days followed by gradual tapering
No additional anti-edema treatment
NO INTERVENTIONNo additional treatment
Interventions
Eligibility Criteria
You may qualify if:
- Calcified NCC
- Perilesional edema on CT or MRI
- Normal lab values
You may not qualify if:
- Viable neurocysticercosis
- Status epilepticus
- Symptomatic intracranial hypertension
- Tuberculosis
- More than 7 days after seizure
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cysticercosis Unit, Instituto Nacional de Ciencias Neurologicas
Lima, Lima 1, Peru
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hector H. Garcia, MD, PhD
Universidad Peruana Cayetano Heredia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2016
First Posted
October 26, 2016
Study Start
December 4, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
April 1, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share
As a concrete product, the clinical trial should provide base data to implement an affordable therapy for edema-related seizures. The data produced was going to be published in a peer reviewed journal; nevertheless, the study was prematurely terminated due to low recruitment.