NeurocysticercosisPhase 3NCT00290823
Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients
A Phase 3 study testing Albendazole, Dexamethasone and Omeprazole in people with Neurocysticercosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Peru.
Trial summary
The purpose of this study is to determine whether a short course of increased corticosteroid dosing with tapered dosing decreases seizure frequency as compared to standard corticosteroid dosing in patients with neurocysticercosis (NCC). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neurocysticercosis
- What is being tested?
- Albendazole, Dexamethasone and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePeru
- Study dates
- Apr 2006to Mar 2011
- Phase
- Phase 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
- Diagnosed with intraparenchymal NCC with 20 or fewer active cysts, as confirmed by enzyme-linked immunoelectrotransfer blot (EITB)
- Diagnosed with epilepsy secondary to NCC, with history of one or more spontaneous seizures within the 6 months prior to study entry
- Willingness to be hospitalized for a minimum of 2 weeks for this study
- PPD negative OR negative smears for tuberculosis (TB) if PPD positive
- Willing to use acceptable forms of contraception during the study and for at least 1 month after albendazole therapy
Who cannot join
- Primary generalized seizures not caused by NCC
- Subarachnoid or ventricular NCC
- Any vesicular lesion greater than 2 cm in diameter
- Previous therapy with albendazole or praziquantel within 2 years of study entry. Patients who have previously received single-dose albendazole for intestinal parasites are not excluded.
- Intracranial hypertension, as confirmed by CT or MRI
- History of status epilepticus
Show all 21Show fewer
- Focal neurological defects
- Unstable or consistently abnormal vital signs (e.g., body temperature, pulse, respiratory rate, blood pressure)
- Cysts in critical regions, including brainstem or the eyes
- Pulmonary TB
- History of TB in the patient or history of TB in close contact of patient
- Chest x-ray suggestive of past or current TB
- Diabetes
- Systemic conditions (e.g., chronic kidney failure, liver disease, heart failure, steroid-dependent immune diseases) other than NCC that may interfere with the study
- Predicted survival time of less than 1 year
- Inability to undergo CT or MRI
- Hypersensitivity to albendazole, antiepileptic drugs, or contrast
- Hypertension at rest
- Require corticosteroids, received corticosteroids in the 4 weeks prior to study entry, or received corticosteroids for 9 or more days within the 6 months prior to study entry
- Other CNS processes that may interfere with study assessments
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Intraparenchymal Neurocysticercosis: Effect of Increased Dosing of Corticosteroids on Seizure Frequency
The purpose of this study is to determine whether a short course of increased corticosteroid dosing with tapered dosing decreases seizure frequency as compared to standard corticosteroid dosing in patients with neurocysticercosis (NCC).
Read the detailed description
NCC is the most common parasitic infection of the central nervous system (CNS). It is caused by ingestion of eggs from a tapeworm of genus Taenia. Inflammation, seizures, or neurologic problems may occur in a patient with NCC. Corticosteroids are the current standard of care for NCC patients, but corticosteroids have many side effects. Albendazole is used to treat infections caused by worms; however, it is unclear if its use with the corticosteroid dexamethasone will decrease seizure frequency in NCC patients. The purpose of this study is to evaluate the efficacy of reducing seizure frequency with a short course of dexamethasone with tapered dosing when given with albendazole, as compared to standard dexamethasone and albendazole treatment, in NCC patients.
In this open label study, patients will be randomly assigned to one of two arms. Group I will receive 6 mg dexamethasone daily for 10 days only. Group II will receive 6 mg dexamethasone daily for 10 days, then 8 mg dexamethasone daily for 4 weeks with a 2-week taper. Both groups will also receive albendazole and omeprazole (a medicine that helps prevent gastroesophageal disease [GERD], a side effect of corticosteroid use). There will be 13 study visits over a 360-day period. Blood collection will occur at most visits. Group II will also undergo sputum smears and rapid culture testing on Days 14, 28, and 42. Patients will undergo magnetic resonance imaging (MRI) at screening and on Day 180 and computed tomography (CT) scanning on Day 360.
- Conditions
- Neurocysticercosis
- Being tested
- Albendazole, Dexamethasone, Omeprazole
- Keywords
- Taenia, Seizures, Tapeworm, Parasite
- Medical subject headings
- Neurocysticercosis, Seizures, Cestode Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
400 mg tablet taken orally twice daily
DexamethasoneDrug
6mg or 8mg taken daily
OmeprazoleDrug
20 mg tablet taken orally daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive 6 mg dexamethasone daily for 10 days Participants will also receive albendazole and omeprazole. Receives: Drug: Albendazole; Drug: Dexamethasone; Drug: Omeprazole |
| 2 | Experimental | Participants will receive 6 mg dexamethasone daily for 10 days, then 8 mg dexamethasone daily for 4 weeks with a 2-week taper. Participants will also receive albendazole and omeprazole. Receives: Drug: Albendazole; Drug: Dexamethasone; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative frequency of partial, generalized, and total seizures
Measured: Through Day 42
Secondary outcomes (1)
Cumulative frequency of generalized seizures
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startApr 2006
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NeurocysticercosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Theodore E. Nash, MD, Principal investigator, Gastrointestinal Parasites Section, Laboratory of Parasitic Diseases, NIAIDHector H. Garcia, MD, PhD, Study director, Department of Microbiology, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290823
- Sponsor's protocol ID
- 05IN214
- Other IDs
- 05-I-N214
- Status last verified
- Feb 2017
- First submitted
- 9 Feb 2006
- Last updated
- 3 Feb 2017
- Results posted
- No
Publications
Del Brutto OH. Neurocysticercosis. Semin Neurol. 2005 Sep;25(3):243-51. doi: 10.1055/s-2005-917661.
PubMed 16170737Garcia HH, Gilman R, Martinez M, Tsang VC, Pilcher JB, Herrera G, Diaz F, Alvarado M, Miranda E. Cysticercosis as a major cause of epilepsy in Peru. The Cysticercosis Working Group in Peru (CWG). Lancet. 1993 Jan 23;341(8839):197-200. doi: 10.1016/0140-6736(93)90064-n.
PubMed 8093496Medina MT, Rosas E, Rubio-Donnadieu F, Sotelo J. Neurocysticercosis as the main cause of late-onset epilepsy in Mexico. Arch Intern Med. 1990 Feb;150(2):325-7.
PubMed 2302008
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Intraparenchymal Neurocysticercosis: Effect of Increased Dosing of Corticosteroids on Seizure Frequency
- ClinicalTrials.gov ID
- NCT00290823
- Acronym / sponsor ID
- 05IN214
- Conditions
- Neurocysticercosis
- Keywords
- Taenia, Seizures, Tapeworm, Parasite
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Apr 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 Feb 2006 (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.
The purpose of this study is to determine whether a short course of increased corticosteroid dosing with tapered dosing decreases seizure frequency as compared to standard corticosteroid dosing in patients with neurocysticercosis (NCC).
Detailed description
NCC is the most common parasitic infection of the central nervous system (CNS). It is caused by ingestion of eggs from a tapeworm of genus Taenia. Inflammation, seizures, or neurologic problems may occur in a patient with NCC. Corticosteroids are the current standard of care for NCC patients, but corticosteroids have many side effects. Albendazole is used to treat infections caused by worms; however, it is unclear if its use with the corticosteroid dexamethasone will decrease seizure frequency in NCC patients. The purpose of this study is to evaluate the efficacy of reducing seizure frequency with a short course of dexamethasone with tapered dosing when given with albendazole, as compared to standard dexamethasone and albendazole treatment, in NCC patients.
In this open label study, patients will be randomly assigned to one of two arms. Group I will receive 6 mg dexamethasone daily for 10 days only. Group II will receive 6 mg dexamethasone daily for 10 days, then 8 mg dexamethasone daily for 4 weeks with a 2-week taper. Both groups will also receive albendazole and omeprazole (a medicine that helps prevent gastroesophageal disease [GERD], a side effect of corticosteroid use). There will be 13 study visits over a 360-day period. Blood collection will occur at most visits. Group II will also undergo sputum smears and rapid culture testing on Days 14, 28, and 42. Patients will undergo magnetic resonance imaging (MRI) at screening and on Day 180 and computed tomography (CT) scanning on Day 360.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Albendazole, Drug: Dexamethasone, Drug: OmeprazoleParticipants will receive 6 mg dexamethasone daily for 10 days Participants will also receive albendazole and omeprazole. |
| 2 | Experimental | Drug: Albendazole, Drug: Dexamethasone, Drug: OmeprazoleParticipants will receive 6 mg dexamethasone daily for 10 days, then 8 mg dexamethasone daily for 4 weeks with a 2-week taper. Participants will also receive albendazole and omeprazole. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with intraparenchymal NCC with 20 or fewer active cysts, as confirmed by enzyme-linked immunoelectrotransfer blot (EITB)
- Diagnosed with epilepsy secondary to NCC, with history of one or more spontaneous seizures within the 6 months prior to study entry
- Willingness to be hospitalized for a minimum of 2 weeks for this study
- PPD negative OR negative smears for tuberculosis (TB) if PPD positive
- Willing to use acceptable forms of contraception during the study and for at least 1 month after albendazole therapy
Key exclusion criteria (21 listed)
- Primary generalized seizures not caused by NCC
- Subarachnoid or ventricular NCC
- Any vesicular lesion greater than 2 cm in diameter
- Previous therapy with albendazole or praziquantel within 2 years of study entry. Patients who have previously received single-dose albendazole for intestinal parasites are not excluded.
- Intracranial hypertension, as confirmed by CT or MRI
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 |
|---|---|---|
| Albendazole400 mg tablet taken orally twice daily | Drug | 1, 2 |
| Dexamethasone6mg or 8mg taken daily | Drug | 1, 2 |
| Omeprazole20 mg tablet taken orally daily | Drug | 1, 2 |
Primary outcome
Cumulative frequency of partial, generalized, and total seizures
Time frame: Through Day 42
1 secondary outcome
Cumulative frequency of generalized seizures
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Background: PubMed 16170737Del Brutto OH. Neurocysticercosis. Semin Neurol. 2005 Sep;25(3):243-51. doi: 10.1055/s-2005-917661.
- Background: PubMed 8093496Garcia HH, Gilman R, Martinez M, Tsang VC, Pilcher JB, Herrera G, Diaz F, Alvarado M, Miranda E. Cysticercosis as a major cause of epilepsy in Peru. The Cysticercosis Working Group in Peru (CWG). Lancet. 1993 Jan 23;341(8839):197-200. doi: 10.1016/0140-6736(93)90064-n.
- Background: PubMed 2302008Medina MT, Rosas E, Rubio-Donnadieu F, Sotelo J. Neurocysticercosis as the main cause of late-onset epilepsy in Mexico. Arch Intern Med. 1990 Feb;150(2):325-7.
Related trials for Neurocysticercosis
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis
Not yet recruitingPhase 2/3
Oxfendazole in Mild Parenchymal Brain Cysticercosis
Brain Cysticercosis
Not yet recruiting
The Impact of Medical TV Drama in Improving Literacy on Neurocysticercosis
Neurocysticercosis, Health Literacy
Not yet recruitingPhase 4
Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis
Neurocysticercosis
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.
Theodore E. Nash, MD principal investigator
Gastrointestinal Parasites Section, Laboratory of Parasitic Diseases, NIAID
Hector H. Garcia, MD, PhD study director
Department of Microbiology, 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 3 study testing Albendazole, Dexamethasone and Omeprazole in people with Neurocysticercosis, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 5 inclusion and 21 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: finished, as of the sponsor's last update on 3 Feb 2017. 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 phase mean?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumulative frequency of partial, generalized, and total seizures (time frame: Through Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00290823, which also lists 3 linked publications.
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 3 Feb 2017.