Phase 3
Completed N=156
Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ)
Neurocysticercosis · Epilepsy
Source: ClinicalTrials.gov NCT00441285 ↗
Enrolled (actual)
156
Serious AEs
12.5%
Results posted
Aug 2013
Primary outcomePrimary: PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1 — 1412.2; 1111 ng*h/mL
Summary
The purpose of this study is to determine if combination drug therapy of praziquantel and albendazole is safe and effective to cure neurocysticercosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1 |
1412.2; 1111 | — |
| PRIMARY PK Substudy - Area Under the Curve of Albendazole in Treatment Days 10 and 11 |
4925.3; 2969.6 | — |
| PRIMARY PK Substudy - Maximum Concentration of Albendazole |
1293.9; 2232.8 | — |
| PRIMARY Phase III Trial - Proportion of Patients Without Remaining Live Cysts |
25; 19; 15 | — |
| SECONDARY PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Day 1 |
548.3; 923.7 | — |
| SECONDARY PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Days 10 and 11 |
240.2; 550.1 | — |
| SECONDARY PK Substudy - Safety of Combined Albendazole Plus Praziquantel Therapy |
0; 0 | — |
| SECONDARY Phase III Trial - Proportion of Cysts Which Resolved |
— | — |
| SECONDARY Phase III Trial - Seizure Frequency |
— | — |
Eligibility Criteria
For parent study:
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT00441285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.