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

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

Study Overview

• Status: Terminated
• Conditions: Neurocysticercosis
• Intervention / Treatment: Drug: Acetazolamide; Drug: Dexamethasone

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Peru
  • Lima, Peru, Lima 1
    • Cysticercosis Unit, Instituto Nacional de Ciencias Neurologicas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acetazolamide; 750 mg acetazolamide p.o. divided in three dily doses, for 10 days	Drug: Acetazolamide; As described above
Active Comparator: Dexamethasone; 8 mg p.o. divided in three daily daily doses, for 2 days followed by gradual tapering	Drug: Dexamethasone; As described above
No Intervention: No additional anti-edema treatment; No additional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in Volume of Perilesional Edema Between Baseline and Day 4	MRI extension of edema	Baseline to Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in Volume of Perilesional Edema Between Baseline and Day 8	MRI extension of edema	Baseline to Day 8
Decrease in Volume of Perilesional Edema Between Baseline and Day 30	MRI extension of edema	Baseline to Day 30

Collaborators and Investigators

• Sponsor: Universidad Peruana Cayetano Heredia
• Investigators: Study Chair: Hector H. Garcia, MD, PhD, Universidad Peruana Cayetano Heredia

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Parasitic Diseases; Helminthiasis; Cestode Infections; Central Nervous System Helminthiasis; Central Nervous System Parasitic Infections; Cysticercosis; Taeniasis; Neurocysticercosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Carbonic Anhydrase Inhibitors; Natriuretic Agents; Diuretics; Anticonvulsants; Dexamethasone; Acetazolamide
• Other Study ID Numbers: 62352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.