Treatment of Patients With Active Neurocysticercosis in Eastern Africa

Neurocysticercosis Clinical Trial

— TOPANA  

Official title:

Characteristics of Patients With Symptomatic Active Neurocysticercosis and Effect of Treatment on Symptoms, Lesions and Quality of Life in Resource-poor Rural Areas of Eastern Africa - TOPANA, a Multi-centre Prospective Cohort Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03834337
• Other study ID #: TOPANA
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: November 2023
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This multi-centre prospective cohort study of symptomatic patients with active neurocysticercosis (NCC) aims to identify factors related to treatment success of anthelmintic therapy. Neurological symptom/sign and cyst resolution, quality of life, accuracy and performance of serological T. solium diagnostics and NCC-specific immunological parameter will be followed up at multiple time points in the study. The final assessment will be done six months after the end of anthelmintic treatment. This study aims to guide treatment of NCC in sub-Saharan Africa by identifying factors that are associated with treatment outcomes. The factors that cause some people to fail complete resolution of all cysts and/or symptoms/signs are unknown.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• All patients will be included who
• Meet the definitions of active NCC
• Have epilepsy, epileptic seizures or chronic/severe progressive headaches
• Are physically and mentally fit enough for treatment
• Are willing to be hospitalized and to receive the standard treatment for NCC
• Are willing to participate a follow-up for six months
• Are willing and able to consent to this study, with consent recorded on a signed consent form

Exclusion Criteria:

• Potential participants who will not meet the above inclusion criteria will be excluded.
• Women who are pregnant will not be included, but re-evaluated for inclusion into the study after they have given birth.
• Potential participants who are currently taking or have taken albendazole, praziquantel, or a corticosteroid within the past 12 months will be excluded.
• People with uncontrolled hypertension and/or diabetes will be excluded from the study but will be re-evaluated for inclusion once their hypertension and/or diabetes have been treated.
• People with chronic consuming illness such as cancer and those with mental handicap severe enough to not allow them to follow the study instructions or reliably take their medication will be excluded.
• Children aged <10 years.

Related Conditions & MeSH terms

• Cysticercosis
• Neurocysticercosis

Locations

Country	Name	City	State
Tanzania	National Institute of Medical Research	Dar Es Salaam

Sponsors (4)

Lead Sponsor	Collaborator
Technical University of Munich	National Institute for Medical Research, Tanzania, Sokoine University of Agriculture, University of Zambia

Country where clinical trial is conducted

Tanzania, 

References & Publications (1)

Stelzle D, Makasi C, Schmidt V, Trevisan C, Van Damme I, Ruether C, Dorny P, Magnussen P, Zulu G, Mwape KE, Bottieau E, Prazeres da Costa C, Prodjinotho UF, Carabin H, Jackson E, Fleury A, Gabriel S, Ngowi BJ, Winkler AS. Efficacy and safety of antiparasi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of lesions	The number of active cysts identified by CT scan after treatment	Change in number of active cysts from before treatment to six months after treatment termination
Primary	Symptom/sign frequency	The percentage of participants who exhibit a neurological symptom/sign of NCC: chronic/severe progressive headache or epileptic seizures.	Change of symptom/sign frequency from before treatment to six months after treatment termination
Secondary	Health-related Quality of Life (all patients): WHOQOL-Bref questionnaire	The change in participants' self-reported quality of life from before to after treatment, as measured by the WHOQOL-Bref questionnaire (in all participants) [World Health Organization Quality of Life questionnaire; consisting of 26 items].; Quality of life is assessed by four domains - physical health, psychological, social relationships and environment. In each domain a score of 0 to 100 can be achieved. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). Domains are not summarised to an overall score.	Change in quality of life from before treatment to six months after treatment termination
Secondary	Health-related Quality of Life (epileptic patients)	The change in participants' self-reported quality of life from before to after treatment, as measured by the QOLIE-31 questionnaire [Quality of life in epilepsy - 31 items].; The score consists of 7 domains which all are range from 0 to 100%. Those domains are: seizure worry, overall quality of life, emotional well-being, energy/fatigue, cognitive, medication effects, social function. The seven domains are then summarized to an overall score by applying weights to each category. The overall score ranges from 0 to 100% with 100% being best possible quality of life.	Change in quality of life from before treatment to six months after treatment termination
Secondary	Change in presence of T.solium-specific antigen	Change in presence of T.solium-specific antigen in the blood of patients with active neurocysticercosis	Change in presence of T.solium-specific antigen from before treatment to six months after treatment termination

External Links

•   Efficacy and safety of antiparasitic therapy for neurocysticercosis in rural Tanzania: a prospective cohort study