NeurocysticercosisPhase 2/3NCT00441285
Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ)
A Phase 2/3 study testing Praziquantel and Albendazole in people with Neurocysticercosis and Epilepsy, run by Universidad Peruana Cayetano Heredia at 5 sites in Peru.
Trial summary
The purpose of this study is to determine if combination drug therapy of praziquantel and albendazole is safe and effective to cure neurocysticercosis. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Neurocysticercosis, Epilepsy
- What is being tested?
- Praziquantel and Albendazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 5 sitesPeru
- Study dates
- Jan 2010to Sep 2013
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female individuals between 16 to 65 years of age, with a diagnosis of Neurocysticercosis and 20 or less viable cysts.
- Patients with a diagnosis of epilepsy secondary to Neurocysticercosis and a history of one or more spontaneous seizures within the previous year but not longer than 10 years.
- Willingness to complete a minimum of two weeks of hospitalization.
- If female of child bearing potential, negative urine pregnancy testing and willingness to use an adequate method of contraception while on study medications and for at least 3 months following Albendazole therapy.
- Normal laboratory values for hematocrit, platelets, white blood cells and glucose and normal or decreased values for Alanine transaminase, Aspartate transaminase and creatinine.
- Negative PPD measurement and if positive ( > 9mm induration in the absence of other findings or immunosuppression ) , negative smears for TB.
- Negative fecal exam for Taenia eggs or Strongyloides larvae.
Who cannot join
- Primary generalized seizures ( e.g., not caused by Neurocysticercosis )
- A history of generalized epileptic status .
- A type of Neurocysticercosis which can expose the patient to increased risk during the study.
- Patients with persistent or progressive symptomatic intracranial hypertension or intracranial hypertension.
- Previous therapy with Albendazole or Praziquantel in the previous year.
- Pulmonary tuberculosis, or symptoms compatible with tuberculosis not otherwise explained.
Show all 15Show fewer
- Active hepatitis
- Systemic disease that may affect short term prognosis.
- Patients in unstable condition ( consistently abnormal vital signs: body temperature, heart rate, respiratory rate, and blood pressure )
- Pregnancy during antiparasitic treatment
- History of hypersensitivity to Albendazole or Praziquantel
- Concurrent treatment with Cimetidine or Theophylline
- Chronic alcohol or drug abuse
- Unwilling or unable to provide a Computed tomography initially or an Magnetic resonance imaging at 6 months ( as patients with ferromagnetic implants ) , Computed tomography at the end of therapy.
- Unwillingness of subject or legal representative to give written informed consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Peru5 sites
Hospital Nacional Edgardo Rebagliati
Lima, Lima Province, Lima 11
Hospital Nacional Cayetano Heredia
Lima, Lima Province, Lima 31
Hospital Nacional Guillermo Almenara
Lima, Lima Province, Lima 5
Instituto Nacional de Ciencias Neurologicas
Lima
Universidad Peruana Cayetano Heredia
Lima
About this study
Official title: Antiparasitic Therapy for Neurocysticercosis: Phase II/III Study on Safety and Efficacy of Combined Treatment With Praziquantel and Albendazole
The purpose of this study is to determine if combination drug therapy of praziquantel and albendazole is safe and effective to cure neurocysticercosis.
Read the detailed description
Neurocysticercosis is the single major cause of acquired or late-onset epilepsy in the world, and a common diagnosis in immigrant populations in the United States and other industrialized countries. An estimated 50 million humans are affected by Neurocysticercosis. The disease occurs when a parasite called Taenia solium, or the pig tapeworm, infects the brain, forming cysts. Neurocysticercosis is generally treated with 1 of 2 drugs, praziquantel or albendazole. However, current treatment with either of these drugs alone is not totally effective.
The goal of this trial is to determine if combination drug therapy of praziquantel and albendazole is safe and more effective to cure Neurocysticercosis than either drug administered alone. This trial will consist of two sub-studies and a parent study.
In the first substudy which was performed and completed as the initial part and guide to the design of the parent study, a series of 32 patients with viable cystic intraparenchymal Neurocysticercosis were treated with either albendazole ( 15 mg / kg /d ) + praziquantel ( 50 mg / kg/ d ) or albendazole+Placebo in a double blind randomized study. Half of patients in each group had their seizure disorder treated with phenytoin and the other half with carbamazepine (not assigned by the study). The study was designed and powered for pharmacokinetic evaluation and exploratory safety so comparative cysticidal efficacy has not yet been analyzed. There were no safety concerns. Pharmacokinetics of ABZ and PZQ were obtained and described.
In the parent study, a total of 240 participants ( including the 32 participants from the first substudy ) will be randomly chosen to receive albendazole + praziquantel, albendazole + placebo or albendazole at an increased dose + placebo for 10 days. These groups will also receive other standard medications to manage the disease including appropriate anti-epileptic drug therapy. Participants will stay in the hospital for at least 2 weeks after treatment begins, which includes 5 days after the end of anti-parasitic treatment. After discharge from the hospital, follow-up visits will be on days 21 and 30 after treatment begins, then monthly until day 90, and finally every 3 months until completing 18 months. Brain images will be taken at 6 and 12 months after treatment begins. For participants, duration of the trial is 1 year and a half.
- Conditions
- Neurocysticercosis, Epilepsy
- Being tested
- Praziquantel, Albendazole, ABZ Placebo, PZQ Placebo
- Keywords
- neurocysticercosis, NCC, praziquantel, PZQ, albendazole, ABZ, parasite, pig tapeworm, Taenia solium, epilepsy, late-onset epilepsy, acquired epilepsy
- Medical subject headings
- Neurocysticercosis, Epilepsy, Taeniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PraziquantelDrug
Also called PZQ
- Praziquantel 50 mg / kg / d (up to 3600 mg / d ) for 10 days.
AlbendazoleDrug
Also called ABZ
- Albendazole 15 mg / kg / d ( up to 800 mg /d ) in Arm I for 10 days.
- Albendazole at an increased dose, 22.5 mg / kg / d (up to 1200 mg / d ), in Arm II for 10 days.
ABZ PlaceboDrug
Also called Placebo of Albendazole
- Placebo (of Albendazole ) 7.5 mg / kg / d in Arm I and II for 10 days.
PZQ PlaceboDrug
Also called Placebo of PZQ
- Placebo (of Praziquantel) 50 mg / kg / d in Arm II and III for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| I. ABZ + ABZ Placebo + PZQ | Active comparator | Albendazole 15 mg / kg / d (until 800 mg / d) + Placebo of Albendazole ( 7.5 mg / Kg / d )+ Praziquantel 50 mg / kg / d (until 3600 mg / d) Receives: Drug: Praziquantel; Drug: Albendazole; Drug: ABZ Placebo |
| II.- ABZ + ABZ Placebo + PZQ Placebo | Active comparator | Albendazole 15 mg / kg / d ( until 800 mg / d ) + Placebo of Albendazole ( 7.5 mg / Kg / d ) + Placebo of Praziquantel ( 50 mg / kg / d ) Receives: Drug: Albendazole; Drug: ABZ Placebo; Drug: PZQ Placebo |
| III .- Albendazole + PZQ Placebo | Active comparator | Albendazole 22.5 mg / kg / d (until 1200 mg / d) + Placebo of Praziquantel ( 50 mg / kg / d )
This arm was not used in the first substudy ( initial part and guide to the design of the parent study ) however it will be used henceforward. Receives: Drug: Albendazole; Drug: PZQ Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1
- To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose on Treatment day 1
PK Substudy - Area Under the Curve of Albendazole in Treatment Days 10 and 11
- To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).
Measured: 0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on Treatment days 10-11
PK Substudy - Maximum Concentration of Albendazole
Highest serum level of Albendazole measured from all level assessments in the curve.
Measured: Treatment day 1 and Treatment days 10-11
Phase III Trial - Proportion of Patients Without Remaining Live Cysts
Proportion of patients whose 6 month MR does not show viable parasites anymore
Measured: Day 180
Secondary outcomes (5)
PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Day 1
- To evaluate the kinetic disposition of Praziquantel by antiepileptic drug after the last praziquantel dose, we calculated the Area Under the Curve of Praziquantel with Carbamazepine or Phenytoin
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose in treatment day 1
PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Days 10 and 11
- To evaluate the kinetic disposition of Praziquantel by antiepileptic drug after the last praziquantel dose, we calculated the Area Under the Curve of Praziquantel with Carbamazepine or Phenytoin
Measured: 0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on treatment days 10-11
PK Substudy - Safety of Combined Albendazole Plus Praziquantel Therapy
- Describe if some Serious Adverse Event was associated to combined Albendazole plus Praziquantel therapy.
Measured: 90 days post tx
Phase III Trial - Proportion of Cysts Which Resolved
Proportion of Viable Brain Parasites which Are not Alive Anymore at 6 Months MRI
Measured: Day 180
Phase III Trial - Seizure Frequency
Seizure frequency by treatment group
Measured: Day 1 - 540
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2007 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 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, Principal investigator, Universidad Peruana Cayetano HerediaE. Javier Pretell, MD, Principal investigator, Hospital AlbertoJavier A. Bustos, MD, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441285
- Sponsor's protocol ID
- R01NS054805
- Other IDs
- R01NS054805
- Status last verified
- May 2015
- First submitted
- 27 Feb 2007
- Last updated
- 11 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Garcia HH, Lescano AG, Lanchote VL, Pretell EJ, Gonzales I, Bustos JA, Takayanagui OM, Bonato PS, Horton J, Saavedra H, Gonzalez AE, Gilman RH; Cysticercosis Working Group in Peru. Pharmacokinetics of combined treatment with praziquantel and albendazole in neurocysticercosis. Br J Clin Pharmacol. 2011 Jul;72(1):77-84. doi: 10.1111/j.1365-2125.2011.03945.x.
PubMed 21332573Garcia HH, Gonzales I, Lescano AG, Bustos JA, Zimic M, Escalante D, Saavedra H, Gavidia M, Rodriguez L, Najar E, Umeres H, Pretell EJ; Cysticercosis Working Group in Peru. Efficacy of combined antiparasitic therapy with praziquantel and albendazole for neurocysticercosis: a double-blind, randomised controlled trial. Lancet Infect Dis. 2014 Aug;14(8):687-695. doi: 10.1016/S1473-3099(14)70779-0. Epub 2014 Jul 3.
PubMed 24999157Garcia HH, Lescano AG, Gonzales I, Bustos JA, Pretell EJ, Horton J, Saavedra H, Gonzalez AE, Gilman RH; Cysticercosis Working Group in Peru. Cysticidal Efficacy of Combined Treatment With Praziquantel and Albendazole for Parenchymal Brain Cysticercosis. Clin Infect Dis. 2016 Jun 1;62(11):1375-9. doi: 10.1093/cid/ciw134. Epub 2016 Mar 16.
PubMed 26984901
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiparasitic Therapy for Neurocysticercosis: Phase II/III Study on Safety and Efficacy of Combined Treatment With Praziquantel and Albendazole
- ClinicalTrials.gov ID
- NCT00441285
- Acronym / sponsor ID
- R01NS054805
- Conditions
- Neurocysticercosis, Epilepsy
- Keywords
- neurocysticercosis, NCC, praziquantel, PZQ, albendazole, ABZ, parasite, pig tapeworm
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 Feb 2007 (estimated)
- Results
- Posted 7 Aug 2013
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 if combination drug therapy of praziquantel and albendazole is safe and effective to cure neurocysticercosis.
Detailed description
Neurocysticercosis is the single major cause of acquired or late-onset epilepsy in the world, and a common diagnosis in immigrant populations in the United States and other industrialized countries. An estimated 50 million humans are affected by Neurocysticercosis. The disease occurs when a parasite called Taenia solium, or the pig tapeworm, infects the brain, forming cysts. Neurocysticercosis is generally treated with 1 of 2 drugs, praziquantel or albendazole. However, current treatment with either of these drugs alone is not totally effective.
The goal of this trial is to determine if combination drug therapy of praziquantel and albendazole is safe and more effective to cure Neurocysticercosis than either drug administered alone. This trial will consist of two sub-studies and a parent study.
In the first substudy which was performed and completed as the initial part and guide to the design of the parent study, a series of 32 patients with viable cystic intraparenchymal Neurocysticercosis were treated with either albendazole ( 15 mg / kg /d ) + praziquantel ( 50 mg / kg/ d ) or albendazole+Placebo in a double blind randomized study. Half of patients in each group had their seizure disorder treated with phenytoin and the other half with carbamazepine (not assigned by the study). The study was designed and powered for pharmacokinetic evaluation and exploratory safety so comparative cysticidal efficacy has not yet been analyzed. There were no safety concerns. Pharmacokinetics of ABZ and PZQ were obtained and described.
In the parent study, a total of 240 participants ( including the 32 participants from the first substudy ) will be randomly chosen to receive albendazole + praziquantel, albendazole + placebo or albendazole at an increased dose + placebo for 10 days. These groups will also receive other standard medications to manage the disease including appropriate anti-epileptic drug therapy. Participants will stay in the hospital for at least 2 weeks after treatment begins, which includes 5 days after the end of anti-parasitic treatment. After discharge from the hospital, follow-up visits will be on days 21 and 30 after treatment begins, then monthly until day 90, and finally every 3 months until completing 18 months. Brain images will be taken at 6 and 12 months after treatment begins. For participants, duration of the trial is 1 year and a half.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I. ABZ + ABZ Placebo + PZQ | Active comparator | Drug: Praziquantel, Drug: Albendazole, Drug: ABZ PlaceboAlbendazole 15 mg / kg / d (until 800 mg / d) + Placebo of Albendazole ( 7.5 mg / Kg / d )+ Praziquantel 50 mg / kg / d (until 3600 mg / d) |
| II.- ABZ + ABZ Placebo + PZQ Placebo | Active comparator | Drug: Albendazole, Drug: ABZ Placebo, Drug: PZQ PlaceboAlbendazole 15 mg / kg / d ( until 800 mg / d ) + Placebo of Albendazole ( 7.5 mg / Kg / d ) + Placebo of Praziquantel ( 50 mg / kg / d ) |
| III .- Albendazole + PZQ Placebo | Active comparator | Drug: Albendazole, Drug: PZQ PlaceboAlbendazole 22.5 mg / kg / d (until 1200 mg / d) + Placebo of Praziquantel ( 50 mg / kg / d ) This arm was not used in the first substudy ( initial part and guide to the design of the parent study ) however it will be used henceforward. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female individuals between 16 to 65 years of age, with a diagnosis of Neurocysticercosis and 20 or less viable cysts.
- Patients with a diagnosis of epilepsy secondary to Neurocysticercosis and a history of one or more spontaneous seizures within the previous year but not longer than 10 years.
- Willingness to complete a minimum of two weeks of hospitalization.
- If female of child bearing potential, negative urine pregnancy testing and willingness to use an adequate method of contraception while on study medications and for at least 3 months following Albendazole therapy.
- Normal laboratory values for hematocrit, platelets, white blood cells and glucose and normal or decreased values for Alanine transaminase, Aspartate transaminase and creatinine.
Key exclusion criteria (15 listed)
- Primary generalized seizures ( e.g., not caused by Neurocysticercosis )
- A history of generalized epileptic status .
- A type of Neurocysticercosis which can expose the patient to increased risk during the study.
- Patients with persistent or progressive symptomatic intracranial hypertension or intracranial hypertension.
- Previous therapy with Albendazole or Praziquantel in the previous year.
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 |
|---|---|---|
| PraziquantelAlso: PZQ- Praziquantel 50 mg / kg / d (up to 3600 mg / d ) for 10 days. | Drug | I. ABZ + ABZ Placebo + PZQ |
| AlbendazoleAlso: ABZ* Albendazole 15 mg / kg / d ( up to 800 mg /d ) in Arm I for 10 days. * Albendazole at an increased dose, 22.5 mg / kg / d (up to 1200 mg / d ), in Arm II for 10 days. | Drug | I. ABZ + ABZ Placebo + PZQ, II.- ABZ + ABZ Placebo + PZQ Placebo, III .- Albendazole + PZQ Placebo |
| ABZ PlaceboAlso: Placebo of Albendazole- Placebo (of Albendazole ) 7.5 mg / kg / d in Arm I and II for 10 days. | Drug | I. ABZ + ABZ Placebo + PZQ, II.- ABZ + ABZ Placebo + PZQ Placebo |
| PZQ PlaceboAlso: Placebo of PZQ- Placebo (of Praziquantel) 50 mg / kg / d in Arm II and III for 10 days. | Drug | II.- ABZ + ABZ Placebo + PZQ Placebo, III .- Albendazole + PZQ Placebo |
Primary outcome
PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose on Treatment day 1
- To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).
PK Substudy - Area Under the Curve of Albendazole in Treatment Days 10 and 11
Time frame: 0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on Treatment days 10-11
- To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).
PK Substudy - Maximum Concentration of Albendazole
Time frame: Treatment day 1 and Treatment days 10-11
Highest serum level of Albendazole measured from all level assessments in the curve.
Phase III Trial - Proportion of Patients Without Remaining Live Cysts
Time frame: Day 180
Proportion of patients whose 6 month MR does not show viable parasites anymore
5 secondary outcomes
PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Day 1
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose in treatment day 1
PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Days 10 and 11
Time frame: 0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on treatment days 10-11
PK Substudy - Safety of Combined Albendazole Plus Praziquantel Therapy
Time frame: 90 days post tx
Phase III Trial - Proportion of Cysts Which Resolved
Time frame: Day 180
Phase III Trial - Seizure Frequency
Time frame: Day 1 - 540
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21332573Garcia HH, Lescano AG, Lanchote VL, Pretell EJ, Gonzales I, Bustos JA, Takayanagui OM, Bonato PS, Horton J, Saavedra H, Gonzalez AE, Gilman RH; Cysticercosis Working Group in Peru. Pharmacokinetics of combined treatment with praziquantel and albendazole in neurocysticercosis. Br J Clin Pharmacol. 2011 Jul;72(1):77-84. doi: 10.1111/j.1365-2125.2011.03945.x.
- Results publication: PubMed 24999157Garcia HH, Gonzales I, Lescano AG, Bustos JA, Zimic M, Escalante D, Saavedra H, Gavidia M, Rodriguez L, Najar E, Umeres H, Pretell EJ; Cysticercosis Working Group in Peru. Efficacy of combined antiparasitic therapy with praziquantel and albendazole for neurocysticercosis: a double-blind, randomised controlled trial. Lancet Infect Dis. 2014 Aug;14(8):687-695. doi: 10.1016/S1473-3099(14)70779-0. Epub 2014 Jul 3.
- Derived from this study: PubMed 26984901Garcia HH, Lescano AG, Gonzales I, Bustos JA, Pretell EJ, Horton J, Saavedra H, Gonzalez AE, Gilman RH; Cysticercosis Working Group in Peru. Cysticidal Efficacy of Combined Treatment With Praziquantel and Albendazole for Parenchymal Brain Cysticercosis. Clin Infect Dis. 2016 Jun 1;62(11):1375-9. doi: 10.1093/cid/ciw134. Epub 2016 Mar 16.
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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 principal investigator
Universidad Peruana Cayetano Heredia
E. Javier Pretell, MD principal investigator
Hospital Alberto
Javier A. Bustos, MD principal investigator
Universidad Peruana Cayetano Heredia
5 sites 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 Praziquantel and Albendazole in people with Neurocysticercosis and Epilepsy, run by Universidad Peruana Cayetano Heredia at 5 sites 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 7 inclusion and 15 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 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 7 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1 (time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose on Treatment day 1). The study lists 4 primary outcomes in all. 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 NCT00441285, 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 11 Jun 2015.