Treatment of Peri-calcification Edema in Neurocysticercosis (NCC)

Neurocysticercosis Clinical Trial

Official title:

Open Controled Randomized Pilot Study on the Use of Acetazolamide and Dexamethasone for the Acute Phase of Perilesional Edema in Calcified Neurocysticercosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02945527
• Other study ID #: 62352
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: December 4, 2015
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: Universidad Peruana Cayetano Heredia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Three-arm open, randomized comparative study of acetazolamide, dexamethasone, or no additional treatment to evaluate decrease in peri-calcification edema in neurocysticercosis

Description:

This study will evaluate 24 patients with calcified NCC and edema in three treatment arms to compare the reduction in edema volume

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cysticercosis
• Neurocysticercosis

Intervention

Drug:
• Acetazolamide
As described above
• Dexamethasone
As described above

Locations

Country	Name	City	State
Peru	Cysticercosis Unit, Instituto Nacional de Ciencias Neurologicas	Lima

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Peruana Cayetano Heredia

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Volume of Perilesional Edema Between Baseline and Day 4	MRI extension of edema	Baseline to Day 4
Secondary	Decrease in Volume of Perilesional Edema Between Baseline and Day 8	MRI extension of edema	Baseline to Day 8
Secondary	Decrease in Volume of Perilesional Edema Between Baseline and Day 30	MRI extension of edema	Baseline to Day 30