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TerminatedNCT02945527Updated Apr 1, 2025

Treatment of Peri-calcification Edema in Neurocysticercosis (NCC)

A Phase 2/3 interventional study of Acetazolamide and Dexamethasone in Neurocysticercosis, sponsored by Universidad Peruana Cayetano Heredia. Terminated at 1 site in Peru. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Universidad Peruana Cayetano Heredia · Phase 2/3, Interventional, and Treatment

Why this study was terminated
Low recruitment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Dec 2015, registered May 2016).
Phase
Phase 2/3
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Neurocysticercosis

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03

In context

Neurocysticercosis

21 studies on the registry are indexed under Neurocysticercosis; 5 are open to participants now.

This study's enrollment of 4 is below the median of 107 across 13 interventional studies indexed under Neurocysticercosis.

Browse Neurocysticercosis studies →

Lead sponsor

Universidad Peruana Cayetano Heredia is the lead sponsor of 49 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Calcified NCC
  • Perilesional edema on CT or MRI
  • Normal lab values

Exclusion criteria

Exclusion Criteria:

  • Viable neurocysticercosis
  • Status epilepticus
  • Symptomatic intracranial hypertension
  • Tuberculosis
  • More than 7 days after seizure
  • Pregnancy
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
4 participants (actual)

Study arms

  • Active comparator
    Acetazolamide

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

    Drug: Acetazolamide

  • Active comparator
    Dexamethasone

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

    Drug: Dexamethasone

  • No intervention
    No additional anti-edema treatment

    No additional treatment

Interventions

06

What researchers measure

Primary outcomes

  1. Decrease in Volume of Perilesional Edema Between Baseline and Day 4

    MRI extension of edema

    Time frame: Baseline to Day 4

Secondary outcomes

  1. Decrease in Volume of Perilesional Edema Between Baseline and Day 8

    MRI extension of edema

    Time frame: Baseline to Day 8

  2. Decrease in Volume of Perilesional Edema Between Baseline and Day 30

    MRI extension of edema

    Time frame: Baseline to Day 30

07

Study locations

1 site
  • Cysticercosis Unit, Instituto Nacional de Ciencias Neurologicas
    Lima, Lima 1, Peru
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2015 to primary completion in Dec 2018, 36 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2016
First posted
Oct 26, 2016
StartActual
Dec 4, 2015
Primary completionActual
Dec 2018
CompletionActual
Dec 2018
Last update
Apr 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02945527
Lead sponsor
Universidad Peruana Cayetano Heredia
Responsible party
Sponsor
First posted
Oct 26, 2016
Start date
Dec 4, 2015
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Apr 1, 2025

Study contacts

Hector H. Garcia, MD, PhD
study chair · Universidad Peruana Cayetano Heredia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Acetazolamide · Dexamethasone

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