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Treatment of Peri-calcification Edema in Neurocysticercosis (NCC)

Phase 2
Terminated
Conditions
Neurocysticercosis
Interventions
Registration Number
NCT02945527
Lead Sponsor
Universidad Peruana Cayetano Heredia
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

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
4
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
DexamethasoneDexamethasone8 mg p.o. divided in three daily daily doses, for 2 days followed by gradual tapering
AcetazolamideAcetazolamide750 mg acetazolamide p.o. divided in three dily doses, for 10 days
Primary Outcome Measures
NameTimeMethod
Decrease in Volume of Perilesional Edema Between Baseline and Day 4Baseline to Day 4

MRI extension of edema

Secondary Outcome Measures
NameTimeMethod
Decrease in Volume of Perilesional Edema Between Baseline and Day 8Baseline to Day 8

MRI extension of edema

Decrease in Volume of Perilesional Edema Between Baseline and Day 30Baseline to Day 30

MRI extension of edema

Trial Locations

Locations (1)

Cysticercosis Unit, Instituto Nacional de Ciencias Neurologicas

🇵🇪

Lima, Peru

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