NeurocysticercosisPhase 2/3NCT02945527
Treatment of Peri-calcification Edema in Neurocysticercosis (NCC)
A Phase 2/3 study testing Acetazolamide and Dexamethasone in people with Neurocysticercosis, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
Trial summary
Three-arm open, randomized comparative study of acetazolamide, dexamethasone, or no additional treatment to evaluate decrease in peri-calcification edema in neurocysticercosis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neurocysticercosis
- What is being tested?
- Acetazolamide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 sitePeru
- Study dates
- 4 Dec 2015to Dec 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Calcified NCC
- Perilesional edema on CT or MRI
- Normal lab values
Who cannot join
- Viable neurocysticercosis
- Status epilepticus
- Symptomatic intracranial hypertension
- Tuberculosis
- More than 7 days after seizure
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Peru1 site
Cysticercosis Unit, Instituto Nacional de Ciencias Neurologicas
Lima, Lima 1
About this study
Official title: 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
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
- Conditions
- Neurocysticercosis
- Being tested
- Acetazolamide, Dexamethasone
- Medical subject headings
- Neurocysticercosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
As described above
DexamethasoneDrug
As described above
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide | Active comparator | 750 mg acetazolamide p.o. divided in three dily doses, for 10 days Receives: Drug: Acetazolamide |
| Dexamethasone | Active comparator | 8 mg p.o. divided in three daily daily doses, for 2 days followed by gradual tapering Receives: Drug: Dexamethasone |
| No additional anti-edema treatment | No intervention | No additional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Volume of Perilesional Edema Between Baseline and Day 4
MRI extension of edema
Measured: Baseline to Day 4
Secondary outcomes (2)
Decrease in Volume of Perilesional Edema Between Baseline and Day 8
MRI extension of edema
Measured: Baseline to Day 8
Decrease in Volume of Perilesional Edema Between Baseline and Day 30
MRI extension of edema
Measured: Baseline to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start4 Dec 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurocysticercosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hector H. Garcia, MD, PhD, Study chair, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945527
- Sponsor's protocol ID
- 62352
- Status last verified
- Mar 2025
- First submitted
- 10 May 2016
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Controled Randomized Pilot Study on the Use of Acetazolamide and Dexamethasone for the Acute Phase of Perilesional Edema in Calcified Neurocysticercosis
- ClinicalTrials.gov ID
- NCT02945527
- Acronym / sponsor ID
- 62352
- Conditions
- Neurocysticercosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Active comparator | Drug: Acetazolamide750 mg acetazolamide p.o. divided in three dily doses, for 10 days |
| Dexamethasone | Active comparator | Drug: Dexamethasone8 mg p.o. divided in three daily daily doses, for 2 days followed by gradual tapering |
| No additional anti-edema treatment | No intervention | –No additional treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Calcified NCC
- Perilesional edema on CT or MRI
- Normal lab values
Key exclusion criteria (6 listed)
- Viable neurocysticercosis
- Status epilepticus
- Symptomatic intracranial hypertension
- Tuberculosis
- More than 7 days after seizure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetazolamideAs described above | Drug | Acetazolamide |
| DexamethasoneAs described above | Drug | Dexamethasone |
Primary outcome
Decrease in Volume of Perilesional Edema Between Baseline and Day 4
Time frame: Baseline to Day 4
MRI extension of edema
2 secondary outcomes
Decrease in Volume of Perilesional Edema Between Baseline and Day 8
Time frame: Baseline to Day 8
Decrease in Volume of Perilesional Edema Between Baseline and Day 30
Time frame: Baseline to Day 30
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: 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.
Related trials for Neurocysticercosis
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
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Oxfendazole in Mild Parenchymal Brain Cysticercosis
Brain Cysticercosis
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The Impact of Medical TV Drama in Improving Literacy on Neurocysticercosis
Neurocysticercosis, Health Literacy
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Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hector H. Garcia, MD, PhD study chair
Universidad Peruana Cayetano Heredia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acetazolamide and Dexamethasone in people with Neurocysticercosis, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Volume of Perilesional Edema Between Baseline and Day 4 (time frame: Baseline to Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.