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

NCT06376396 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 101103306
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Neurocysticercosis

Keywords

Neglected Tropical Disease; Epilepsy

Outcome Measures

Primary Outcomes (1)

• Cyst resolution or reduction in both study arms

  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 Outcomes (4)

• Seizures frequency

  6 weeks and 6 months

• Quality of Life questionnaire

  6 weeks, 6 months and 1 year

• Headache

  6 weeks, 6 months and 1 year

• Serological test results correlation with neuroimaging results

  Baseline, 6 weeks, 6 months and 1 year

Study Arms (2)

Albendazole and Praziquantel

EXPERIMENTAL

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

Albendazole

ACTIVE COMPARATOR

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

Interventions

albendazole and praziquantel DRUG

Combination of albendazole plus praziquantel

Also known as: Albendazole, Praziquantel

Albendazole and Praziquantel

Albendazole DRUG

Albendazole alone

Albendazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• R-Evolution Worldwide S.r.l. Impresa Sociale: lead
• Muhimbili University of Health and Allied Sciences: collaborator
• National Institute for Medical Research, Tanzania: collaborator
• Sokoine University of Agriculture: collaborator
• University of Zambia: collaborator
• University Ghent: collaborator

Related Publications (13)

• Adebayo PB, Akinyemi RO, Ogun SA, Ogunniyi A. Seizure severity and health-related quality of life of adult Nigerian patients with epilepsy. Acta Neurol Scand. 2014 Feb;129(2):102-8. doi: 10.1111/ane.12146. Epub 2013 May 18.

  PMID: 23682560 BACKGROUND

• Azimi A, Fattahi R, Asadi-Lari M. Knowledge translation status and barriers. J Med Libr Assoc. 2015 Apr;103(2):96-9. doi: 10.3163/1536-5050.103.2.008. No abstract available.

  PMID: 25918490 BACKGROUND

• Fogang YF, Savadogo AA, Camara M, Toffa DH, Basse A, Sow AD, Ndiaye MM. Managing neurocysticercosis: challenges and solutions. Int J Gen Med. 2015 Oct 16;8:333-44. doi: 10.2147/IJGM.S73249. eCollection 2015.

  PMID: 26527895 BACKGROUND

• Garcia HH, Nash TE, Del Brutto OH. Clinical symptoms, diagnosis, and treatment of neurocysticercosis. Lancet Neurol. 2014 Dec;13(12):1202-15. doi: 10.1016/S1474-4422(14)70094-8. Epub 2014 Nov 10.

  PMID: 25453460 BACKGROUND

• Kinyanjui DW, Kathuku DM, Mburu JM. Quality of life among patients living with epilepsy attending the neurology clinic at Kenyatta National Hospital, Nairobi, Kenya: a comparative study. Health Qual Life Outcomes. 2013 Jun 18;11:98. doi: 10.1186/1477-7525-11-98.

  PMID: 23777194 BACKGROUND

• Makasi CE, Kilale AM, Ngowi BJ, Lema Y, Katiti V, Mahande MJ, Msoka EF, Stelzle D, Winkler AS, Mmbaga BT. Knowledge and misconceptions about epilepsy among people with epilepsy and their caregivers attending mental health clinics: A qualitative study in Taenia solium endemic pig-keeping communities in Tanzania. Epilepsia Open. 2023 Jun;8(2):487-496. doi: 10.1002/epi4.12720. Epub 2023 Mar 20.

  PMID: 36896648 BACKGROUND

• Nau AL, Mwape KE, Wiefek J, Schmidt K, Abatih E, Dorny P, Praet N, Chiluba C, Schmidt H, Phiri IK, Winkler AS, Gabriel S, Blocher J. Cognitive impairment and quality of life of people with epilepsy and neurocysticercosis in Zambia. Epilepsy Behav. 2018 Mar;80:354-359. doi: 10.1016/j.yebeh.2017.10.042. Epub 2017 Dec 6.

  PMID: 29221763 BACKGROUND

• Nyangi C, Stelzle D, Mkupasi EM, Ngowi HA, Churi AJ, Schmidt V, Mahonge C, Winkler AS. Knowledge, attitudes and practices related to Taenia solium cysticercosis and taeniasis in Tanzania. BMC Infect Dis. 2022 Jun 13;22(1):534. doi: 10.1186/s12879-022-07408-0.

  PMID: 35692033 BACKGROUND

• Owolabi LF, Adamu B, Jibo AM, Owolabi SD, Imam AI, Alhaji ID. Neurocysticercosis in people with epilepsy in Sub-Saharan Africa: A systematic review and meta-analysis of the prevalence and strength of association. Seizure. 2020 Jan 7;76:1-11. doi: 10.1016/j.seizure.2020.01.005. Online ahead of print.

  PMID: 31935478 BACKGROUND

• Stelzle D, Makasi C, Schmidt V, Trevisan C, van Damme I, Welte TM, Ruether C, Fleury A, Dorny P, Magnussen P, Zulu G, Mwape KE, Bottieau E, Gabriel S, Ngowi BJ, Winkler AS; SOLID collaborators. Epidemiological, clinical and radiological characteristics of people with neurocysticercosis in Tanzania-A cross-sectional study. PLoS Negl Trop Dis. 2022 Nov 28;16(11):e0010911. doi: 10.1371/journal.pntd.0010911. eCollection 2022 Nov.

  PMID: 36441777 BACKGROUND

• Torgerson PR, Devleesschauwer B, Praet N, Speybroeck N, Willingham AL, Kasuga F, Rokni MB, Zhou XN, Fevre EM, Sripa B, Gargouri N, Furst T, Budke CM, Carabin H, Kirk MD, Angulo FJ, Havelaar A, de Silva N. World Health Organization Estimates of the Global and Regional Disease Burden of 11 Foodborne Parasitic Diseases, 2010: A Data Synthesis. PLoS Med. 2015 Dec 3;12(12):e1001920. doi: 10.1371/journal.pmed.1001920. eCollection 2015 Dec.

  PMID: 26633705 BACKGROUND

• Trevisan C, Damme IV, Ngowi B, Schmidt V, Stelzle D, Moller KS, Kabululu M, Makasi CE, Magnussen P, Bottieau E, Abatih E, Johansen MV, Ngowi H, Ndawi B, Mwape KE, Zulu G, Dorny P, Winkler AS, Gabriel S, On Behalf Of The Solid Consortium. Trial Design of a Prospective Multicenter Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and Neurocysticercosis in Hospital-Based Settings in Tanzania. Diagnostics (Basel). 2021 Aug 24;11(9):1528. doi: 10.3390/diagnostics11091528.

  PMID: 34573870 BACKGROUND

• Braae UC, Saarnak CF, Mukaratirwa S, Devleesschauwer B, Magnussen P, Johansen MV. Taenia solium taeniosis/cysticercosis and the co-distribution with schistosomiasis in Africa. Parasit Vectors. 2015 Jun 12;8:323. doi: 10.1186/s13071-015-0938-7.

  PMID: 26065414 BACKGROUND

Related Links

• WHO guidelines on management of Taenia solium neurocysticercosis

MeSH Terms

Conditions

Neurocysticercosis; Neglected Diseases; Epilepsy

Interventions

Albendazole; Praziquantel

Condition Hierarchy (Ancestors)

Central Nervous System Helminthiasis; Central Nervous System Parasitic Infections; Central Nervous System Infections; Infections; Parasitic Diseases; Cysticercosis; Taeniasis; Cestode Infections; Helminthiasis; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isoquinolines

Study Officials

• Kabemba E. Mwape, Prof.

  University of Zambia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernard J. Ngowi, Dr

CONTACT

+255 252500082; Ngowi.Bernard@udsm.ac.tz

Helena A. Ngowi, Prof.

CONTACT

+255 232640037; helenangowi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: April 19, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 12 months after study completion.
• Access Criteria: Open access