Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis (NeuroSolve)

April 19, 2024 updated by: Dario Scaramuzzi, R-Evolution Worldwide S.r.l. Impresa Sociale

Assessment of Combined Antiparasitic Drugs Praziquantel and Albendazole Versus Albendazole Alone in the Treatment of Active Parenchymal Neurocysticercosis in Tanzania and Zambia

The goal of this clinical trial is to compare the combination albendazole and praziquantel versus albendazole alone in patients affected by neurocysticercosis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, two arms, parallel-groups, open-label clinical trial to assess if the combination of antiparasitic praziquantel and albendazole is better than albendazole alone in the treatment of active parenchymal neurocysticercosis in Tanzania and Zambia.

Background and Study Rationale: between the forms of human cysticercosis caused by Taenia solium, neurocysticercosis is a major contributor to the burden of seizure disorders and epilepsy in most of the world, while it has relatively poor clinical evidence on treatment options, requiring further data, mainly from additional randomized controlled trials. In particular albendazole and praziquantel are the two parasiticides recommended for use in treating active neurocysticercosis (NCC). Specifically, albendazole is recommended for use in patients with a single cyst while both albendazole and praziquantel (combination therapy) are recommended for patients with multiple cysts. However, not all patients with single cysts respond to albendazole monotherapy. Combination therapy may be effective in patients with single cysts as it has already been shown effective for multiple cysts.

Most studies of treatment success for NCC have been conducted in Latin America and India. In India, the studies were performed primarily on singular cystic lesions. Despite Sub-Saharan Africa (SSA) being recognized as endemic for this parasite, no study evaluating the success of standard treatment in humans has been conducted in this region. Additionally, it is difficult to extrapolate information from other regions other than SSA due to possible differences in genetic, clinical, and environmental factors.

Primary Objective:

The primary objective of this study is to determine if the anthelmintics combination of praziquantel and albendazole is better than albendazole alone in the treatment of the active parenchymal neurocysticercosis based on cyst resolution.

Secondary Objectives:

  1. To determine if the combination of antiparasitic praziquantel and albendazole is better than albendazole alone in the treatment of active parenchymal neurocysticercosis based on seizures reduction
  2. To estimate the change in quality of life of patients with active symptomatic NCC before and after treatment with combined antiparasitic treatment and mono…
  3. To assess the role of serology in diagnosis, management and follow up of participants treated for neurocysticercosis.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Living in the study area for a continuous period of 3 years
  • Adult aged 18 years and above
  • Are willing and able to consent to this study
  • Meet the definitions of active symptomatic NCC
  • Have late onset of epilepsy or history of seizures, epileptic seizures
  • Subjects willing to undergo diagnostic procedures
  • Subjects medically stable enough for trial medication to be initiated
  • Subjects willing to be hospitalized for 11-20 days to receive treatment for NCC
  • Subjects willing to be followed up for one year following receipt of study medication

Exclusion Criteria:

  • Women pregnant or breastfeeding
  • Symptomatic NCC with cysts in extra-parenchymal location (sub-arachnoid and/or ventricles)
  • Have uncontrolled hypertension and/or diabetes
  • Have chronic consuming illness such as cancer or mental handicap to not allow them to follow the study instructions
  • Have severe immunodeficiency eg. HIV/AIDS or Autoimmune diseases
  • Already known allergies to albendazole or praziquantel
  • Subject taking part in another clinical/pharmacological study in the 30 days preceding enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Albendazole and Praziquantel
This arm includes combined albendazole with praziquantel, given to approximately 150 participants. Subjects will also receive dexamethasone as an adjunct treatment. An appropriate dose will be calculated per participant's body weight and administered to each participant daily for 10 days. Participants will be monitored for 30 minutes following oral medication, and a repeat dose will be administered if a participant vomits within this observation period. Additional doses (the whole cycle) will be supplied for participants failed to clear NCC in six months.
Drug: albendazole and praziquantel
Combination of albendazole plus praziquantel
Other Names:
  • Albendazole
  • Praziquantel
Active Comparator: Albendazole
This arm includes albendazole monotherapy, given to approximately 150 participants. Subjects will also receive dexamethasone as an adjunct treatment. An appropriate dose will be calculated per participant's body weight and administered to each participant daily for 10 days. Participants will be monitored for 30 minutes following oral medication, and a repeat dose will be administered if a participant vomits within this observation period. Additional doses (the whole cycle) will be supplied for participants failed to clear NCC in six months.
Drug: Albendazole
Albendazole alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cyst resolution or reduction in both study arms
Time Frame: 6 weeks and 6 months
The primary objective of this study is to determine if the anthelmintic combination of praziquantel and albendazole is better than albendazole alone in the treatment of active parenchymal cysticercosis, based on cyst resolution. The cysts resolution is defined by at least 70% resolution at brain imaging (CT scan / MRI) between the baseline imagines and those at 6-week to 6-month following treatment.
6 weeks and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizures frequency
Time Frame: 6 weeks and 6 months
Reduction of seizures frequency at 6-weeks to 6-months following treatment
6 weeks and 6 months
Quality of Life questionnaire
Time Frame: 6 weeks, 6 months and 1 year
The improvement in Quality of life (QoL) at 6-weeks, 6-months and 12-months following treatment.
6 weeks, 6 months and 1 year
Headache
Time Frame: 6 weeks, 6 months and 1 year
The headache severity and frequency will be assessed by in-depth neurological examination, including patient-reported outcome measures (e.g. VAS - Visual Analog Scale), at the following defined time point: baseline, 6 weeks, 6 months and 1 year
6 weeks, 6 months and 1 year
Serological test results correlation with neuroimaging results
Time Frame: Baseline, 6 weeks, 6 months and 1 year
To assess the role of serology in diagnosis, management and follow up of participants treated for neurocysticercosis, antigen and antibody detecting tests results will be done and the results will be compared with neuroimaging (CT/MRI), at baseline, 6-week, 6-month and 1 year following treatment.
Baseline, 6 weeks, 6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R-Evolution Worldwide S.r.l. Impresa Sociale

Collaborators

University Ghent
National Institute for Medical Research, Tanzania
University of Zambia
Muhimbili University of Health and Allied Sciences
Sokoine University of Agriculture

Investigators

  • Principal Investigator: Kabemba E. Mwape, Prof., University of Zambia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 25, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101103306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share the de-identified data on efficacy and safety during publication of the study results.

IPD Sharing Time Frame

Within 12 months after study completion.

IPD Sharing Access Criteria

Open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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