Trial · NCT00441285

Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ)

NCT00441285, Phase 2, Phase 3, Completed, Universidad Peruana Cayetano Heredia; results first posted 2013-08-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ). Trials, record NCT00441285. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00441285

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ)
NCT number: NCT00441285
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 156 participants, actual
Lead sponsor: Universidad Peruana Cayetano Heredia
Conditions: Neurocysticercosis, Epilepsy
Interventions: Praziquantel, Albendazole, ABZ Placebo, PZQ Placebo
First posted: 2007-02-28
Last updated: 2015-06-11
Results first posted: 2013-08-07

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1	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).
Primary	PK Substudy - Area Under the Curve of Albendazole in Treatment Days 10 and 11	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).
Primary	PK Substudy - Maximum Concentration of Albendazole	Treatment day 1 and Treatment days 10-11	Highest serum level of Albendazole measured from all level assessments in the curve.
Primary	Phase III Trial - Proportion of Patients Without Remaining Live Cysts	Day 180	Proportion of patients whose 6 month MR does not show viable parasites anymore
Secondary	PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Day 1	0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose 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
Secondary	PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Days 10 and 11	0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on treatment days 10-11	\- 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
Secondary	PK Substudy - Safety of Combined Albendazole Plus Praziquantel Therapy	90 days post tx	\- Describe if some Serious Adverse Event was associated to combined Albendazole plus Praziquantel therapy.
Secondary	Phase III Trial - Proportion of Cysts Which Resolved	Day 180	Proportion of Viable Brain Parasites which Are not Alive Anymore at 6 Months MRI
Secondary	Phase III Trial - Seizure Frequency	Day 1 - 540	Seizure frequency by treatment group

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1	0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose on Treatment day 1		ng*h/mL	MEAN
PRIMARY	PK Substudy - Area Under the Curve of Albendazole in Treatment Days 10 and 11	0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on Treatment days 10-11		ng*h/ml	MEAN
SECONDARY	PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Day 1	0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose in treatment day 1	Carbamazepine and Phenytoin were not assigned by the study.	ng*h / mL	MEAN
SECONDARY	PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Days 10 and 11	0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on treatment days 10-11		ng*h/ml	MEAN
PRIMARY	PK Substudy - Maximum Concentration of Albendazole	Treatment day 1 and Treatment days 10-11		ng/mL	MEAN
SECONDARY	PK Substudy - Safety of Combined Albendazole Plus Praziquantel Therapy	90 days post tx		Events	NUMBER
SECONDARY	Phase III Trial - Proportion of Cysts Which Resolved	Day 180	Final population numbers for this analysis not yet defined
PRIMARY	Phase III Trial - Proportion of Patients Without Remaining Live Cysts	Day 180	Some patients did not reach the analysis time point.	participants	NUMBER
SECONDARY	Phase III Trial - Seizure Frequency	Day 1 - 540	Final population numbers for this analysis not yet defined

Source ClinicalTrials.gov

Results by group15

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1	Albendazole + Praziquantel		1412.2	95% Confidence Interval 58124.7	ng*h/mL
PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1	Albendazole + Placebo		1111	95% Confidence Interval 32257.1	ng*h/mL
PK Substudy - Area Under the Curve of Albendazole in Treatment Days 10 and 11	Albendazole + Praziquantel		4925.3	95% Confidence Interval 3548.6 to 6302	ng*h/ml
PK Substudy - Area Under the Curve of Albendazole in Treatment Days 10 and 11	Albendazole + Placebo		2969.6	95% Confidence Interval 2543.8 to 3395.4	ng*h/ml
PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Day 1	Albendazole + Praziquantel	Carbamazepine (n=8)	548.3	Standard Deviation 320.9	ng*h / mL
PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Day 1	Albendazole + Praziquantel	Phenytoin (n=8)	923.7	Standard Deviation 424.7	ng*h / mL
PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Days 10 and 11	Carbamazepine		240.2	95% Confidence Interval 151.7 to 328.7	ng*h/ml
PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Days 10 and 11	Phenytoin		550.1	95% Confidence Interval 83.3 to 1183.4	ng*h/ml
PK Substudy - Maximum Concentration of Albendazole	Albendazole + Praziquantel		1293.9	Standard Deviation 3471.6	ng/mL
PK Substudy - Maximum Concentration of Albendazole	Albendazole + Placebo		2232.8	Standard Deviation 6500.7	ng/mL

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PK Substudy ABZ+PZQ	16
Overall Study	STARTED	PK Substudy ABZ+Placebo	16
Overall Study	STARTED	Phase III Trial - ABZ+PZQ	41
Overall Study	STARTED	Phase III Trial - Increased ABZ	40
Overall Study	STARTED	Phase III Trial - Standard ABZ	43
Overall Study	COMPLETED	PK Substudy ABZ+PZQ	16
Overall Study	COMPLETED	PK Substudy ABZ+Placebo	16
Overall Study	COMPLETED	Phase III Trial - ABZ+PZQ	41
Overall Study	COMPLETED	Phase III Trial - Increased ABZ	40
Overall Study	COMPLETED	Phase III Trial - Standard ABZ	43

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Albendazole + Praziquantel	4	16	6
other	Headache	Nervous system disorders	Albendazole + Placebo	5	16	9
other	Abdominal distension	Gastrointestinal disorders	Albendazole + Praziquantel	1	16	1
other	Abdominal distension	Gastrointestinal disorders	Albendazole + Placebo	0	16	0
other	Abdominal pain	Gastrointestinal disorders	Albendazole + Praziquantel	2	16	2
other	Abdominal pain	Gastrointestinal disorders	Albendazole + Placebo	2	16	2
other	Acne	Skin and subcutaneous tissue disorders	Albendazole + Praziquantel	2	16	2
other	Acne	Skin and subcutaneous tissue disorders	Albendazole + Placebo	0	16	0
other	Decreased indirect bilirubin	Gastrointestinal disorders	Albendazole + Praziquantel	1	16	1
other	Decreased indirect bilirubin	Gastrointestinal disorders	Albendazole + Placebo	0	16	0

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Albendazole + Praziquantel
Total, all-cause mortality	Albendazole + Placebo
Total, other adverse events	Albendazole + Praziquantel	15	16
Total, other adverse events	Albendazole + Placebo	12	16
Total, serious adverse events	Albendazole + Praziquantel	2	16
Total, serious adverse events	Albendazole + Placebo	2	16

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21332573	RESULT	PubMed
24999157	RESULT	PubMed
26984901	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01NS054805	Neurocysticercosis: Combined Treatment with Praziquantel and Albendazole	GARCIA, HECTOR HUGO	UNIVERSIDAD PERUANA CAYETANO HEREDIA	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2006 to 2012

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Albendazole + Praziquantel vs Albendazole + Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00441285

GET https://conductscience.org/api/trials/v1/NCT00441285/events?page=2

API reference For AI assistants