Treatment of Peri-calcification Edema in Neurocysticercosis (NCC)

NCT ID: NCT02945527

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-04

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Neurocysticercosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acetazolamide

750 mg acetazolamide p.o. divided in three dily doses, for 10 days

Group Type ACTIVE_COMPARATOR

Acetazolamide

Intervention Type DRUG

As described above

Dexamethasone

8 mg p.o. divided in three daily daily doses, for 2 days followed by gradual tapering

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

As described above

No additional anti-edema treatment

No additional treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acetazolamide

As described above

Intervention Type DRUG

Dexamethasone

As described above

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hector H. Garcia, MD, PhD

Role: STUDY_CHAIR

Universidad Peruana Cayetano Heredia

Locations

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Cysticercosis Unit, Instituto Nacional de Ciencias Neurologicas

Lima, , Peru

Site Status

Countries

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Peru

Other Identifiers

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62352

Identifier Type: -

Identifier Source: org_study_id

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