A Phase 2/3 interventional study of Praziquantel and Albendazole in Neurocysticercosis and Epilepsy, sponsored by Universidad Peruana Cayetano Heredia. Completed at 5 sites in Peru. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-06-11.
Sponsored by Universidad Peruana Cayetano Heredia · Phase 2/3, Interventional, and Treatment
The purpose of this study is to determine if combination drug therapy of praziquantel and albendazole is safe and effective to cure neurocysticercosis.
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.
21 studies on the registry are indexed under Neurocysticercosis; 5 are open to participants now.
This study's enrollment of 156 is above the median of 107 across 13 interventional studies indexed under Neurocysticercosis.
Browse Neurocysticercosis studies →Universidad Peruana Cayetano Heredia is the lead sponsor of 49 studies on the registry; 5 are open to participants now.
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For parent study:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Drug: Praziquantel · Drug: Albendazole · Drug: ABZ Placebo
Albendazole 15 mg / kg / d ( until 800 mg / d ) + Placebo of Albendazole ( 7.5 mg / Kg / d ) + Placebo of Praziquantel ( 50 mg / kg / d )
Drug: Albendazole · Drug: ABZ Placebo · Drug: PZQ Placebo
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.
Drug: Albendazole · Drug: PZQ Placebo
- Praziquantel 50 mg / kg / d (up to 3600 mg / d ) for 10 days.
Also known as: PZQ
* 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.
Also known as: ABZ
- Placebo (of Albendazole ) 7.5 mg / kg / d in Arm I and II for 10 days.
Also known as: Placebo of Albendazole
- Placebo (of Praziquantel) 50 mg / kg / d in Arm II and III for 10 days.
Also known as: Placebo of PZQ
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).
Time frame: 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).
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 - Maximum Concentration of Albendazole
Highest serum level of Albendazole measured from all level assessments in the curve.
Time frame: 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
Time frame: Day 180
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
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
- 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
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
- Describe if some Serious Adverse Event was associated to combined Albendazole plus Praziquantel therapy.
Time frame: 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
Time frame: Day 180
Phase III Trial - Seizure Frequency
Seizure frequency by treatment group
Time frame: Day 1 - 540
This protocol (2 groups, n=180) was modified by the DSMB to add a pharmacokinetics / safety substudy (two groups, n=32). After the substudy results were available, we were approved to proceed with a modified study design (3 groups, n=240). This second study was terminated after enroling patient 124 because of early efficacy (total n= 132+24, 156)
| Milestone | PK Substudy ABZ+PZQ | PK Substudy ABZ+Placebo | Phase III Trial - ABZ+PZQ | Phase III Trial - Increased ABZ | Phase III Trial - Standard ABZ |
|---|---|---|---|---|---|
| Started | 16 | 16 | 41 | 40 | 43 |
| Completed | 16 | 16 | 41 | 40 | 43 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
- 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).
| ng*h/mL | Albendazole + Praziquantel | Albendazole + Placebo |
|---|---|---|
| PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1 | 1412.2 ± 58124.7 | 1111 ± 32257.1 |
- 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).
| ng*h/ml | Albendazole + Praziquantel | Albendazole + Placebo |
|---|---|---|
| PK Substudy - Area Under the Curve of Albendazole in Treatment Days 10 and 11 | 4925.3 (3548.6 to 6302) | 2969.6 (2543.8 to 3395.4) |
- 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
| ng*h / mL | Albendazole + Praziquantel |
|---|---|
| Carbamazepine (n=8) | 548.3 ± 320.9 |
| Phenytoin (n=8) | 923.7 ± 424.7 |
- 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
| ng*h/ml | Carbamazepine | Phenytoin |
|---|---|---|
| PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Days 10 and 11 | 240.2 (151.7 to 328.7) | 550.1 (83.3 to 1183.4) |
Highest serum level of Albendazole measured from all level assessments in the curve.
| ng/mL | Albendazole + Praziquantel | Albendazole + Placebo |
|---|---|---|
| PK Substudy - Maximum Concentration of Albendazole | 1293.9 ± 3471.6 | 2232.8 ± 6500.7 |
- Describe if some Serious Adverse Event was associated to combined Albendazole plus Praziquantel therapy.
| Events | Albendazole + Praziquantel | Albendazole + Placebo |
|---|---|---|
| PK Substudy - Safety of Combined Albendazole Plus Praziquantel Therapy | 0 | 0 |
Proportion of Viable Brain Parasites which Are not Alive Anymore at 6 Months MRI
No measurements were reported for this outcome.
Proportion of patients whose 6 month MR does not show viable parasites anymore
| participants | Phase III Trial - ABZ+PZQ | Phase III Trial - Increased ABZ | Phase III Trial - Standard ABZ |
|---|---|---|---|
| Phase III Trial - Proportion of Patients Without Remaining Live Cysts | 25 | 19 | 15 |
Seizure frequency by treatment group
No measurements were reported for this outcome.
Collected over Number of Serious Adverse Events along the entire follow up (Days 1 - 540). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Albendazole + Praziquantel | — | 2/16 (12.5%) | 15/16 (93.8%) |
| Albendazole + Placebo | — | 2/16 (12.5%) | 12/16 (75%) |
| Event | Albendazole + Praziquantel | Albendazole + Placebo |
|---|---|---|
| Prolonged hospitalizationNervous system disorders | 2/16 | 2/16 |
| Event | Albendazole + Praziquantel | Albendazole + Placebo |
|---|---|---|
| Increased ALTGastrointestinal disorders | 8/16 | 10/16 |
| Increased ASTGastrointestinal disorders | 3/16 | 7/16 |
| HeadacheNervous system disorders | 4/16 | 5/16 |
| HypoesthesiaNervous system disorders | 0/16 | 3/16 |
| Abdominal painGastrointestinal disorders | 2/16 | 2/16 |
| AcneSkin and subcutaneous tissue disorders | 2/16 | 0/16 |
| Decreased White blood cellsBlood and lymphatic system disorders | 2/16 | 1/16 |
| DizzinessNervous system disorders | 0/16 | 2/16 |
| NauseaGastrointestinal disorders | 1/16 | 2/16 |
| Abdominal distensionGastrointestinal disorders | 1/16 | 0/16 |
The population involves 32 patients in the Phase II substudy and 124 patients in the Phase III main study
| Age, Categorical(Participants) | Albendazole + Praziquantel | Albendazole + Placebo | Phase III Trial ABZ+PZQ | Phase III Trial Increased ABZ | Phase III Trial Standard ABZ | Total |
|---|---|---|---|---|---|---|
| <=18 years | 2 | 2 | 0 | 2 | 2 | 8 |
| Between 18 and 65 years | 14 | 14 | 39 | 38 | 41 | 146 |
| >=65 years | 0 | 0 | 2 | 0 | 0 | 2 |
| Age, Continuous(years) | Albendazole + Praziquantel | Albendazole + Placebo | Phase III Trial ABZ+PZQ | Phase III Trial Increased ABZ | Phase III Trial Standard ABZ | Total |
|---|---|---|---|---|---|---|
| Mean | 29.3 ± 9.7 | 27.5 ± 11 | 34 ± 14 | 34 ± 12 | 35 ± 13 | 28 ± 10.2 |
| Sex: Female, Male(Participants) | Albendazole + Praziquantel | Albendazole + Placebo | Phase III Trial ABZ+PZQ | Phase III Trial Increased ABZ | Phase III Trial Standard ABZ | Total |
|---|---|---|---|---|---|---|
| Female | 5 | 6 | 15 | 19 | 14 | 59 |
| Male | 11 | 10 | 26 | 21 | 29 | 97 |
| Region of Enrollment(participants) | Albendazole + Praziquantel | Albendazole + Placebo | Phase III Trial ABZ+PZQ | Phase III Trial Increased ABZ | Phase III Trial Standard ABZ | Total |
|---|---|---|---|---|---|---|
| Peru | 16 | 16 | 41 | 40 | 43 | 156 |
The record gives a start of Jan 2010, a primary completion of Dec 2012 and a completion of Sep 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2013, 8 months after primary completion.
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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Praziquantel
Universidad Peruana Cayetano Heredia