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NCT Number: NCT03834337

Treatment of Patients With Active Neurocysticercosis in Eastern Africa

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.

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Key information

Conditions

Neurocysticercosis Central Nervous System Diseases Central Nervous System Helminthiasis Central Nervous System Infections Central Nervous System Parasitic Infections Cestode Infections Cysticercosis Helminthiasis Infections Nervous System Diseases Parasitic Diseases Taeniasis

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Medical Research

Dar es Salaam, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Resolution of lesions

    Time frame: Change in number of active cysts from before treatment to six months after treatment termination

    The number of active cysts identified by CT scan after treatment

  2. Symptom/sign frequency

    Time frame: Change of symptom/sign frequency from before treatment to six months after treatment termination

    The percentage of participants who exhibit a neurological symptom/sign of NCC: chronic/severe progressive headache or epileptic seizures.

Secondary outcomes

  1. Health-related Quality of Life (all patients): WHOQOL-Bref questionnaire

    Time frame: Change in quality of life from before treatment to six months after treatment termination

    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.

  2. Health-related Quality of Life (epileptic patients)

    Time frame: Change in quality of life from before treatment to six months after treatment termination

    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.

  3. Change in presence of T.solium-specific antigen

    Time frame: Change in presence of T.solium-specific antigen from before treatment to six months after treatment termination

    Change in presence of T.solium-specific antigen in the blood of patients with active neurocysticercosis

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • National Institute for Medical Research, Tanzania
  • Sokoine University of Agriculture
  • University of Zambia

Registry information

Official study 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.

Acronym: TOPANA

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 7, 2019
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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