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CompletedNCT03834337TOPANAUpdated Nov 30, 2023

Treatment of Patients With Active Neurocysticercosis in Eastern Africa

An observational study in Neurocysticercosis, sponsored by Technical University of Munich. Completed at 1 site in Tanzania. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2023-11-30.

Sponsored by Technical University of Munich · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
63
Ages
10 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Neurocysticercosis

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03

In context

Neurocysticercosis

21 studies on the registry are indexed under Neurocysticercosis; 5 are open to participants now.

Browse Neurocysticercosis studies →

Lead sponsor

Technical University of Munich is the lead sponsor of 322 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with active, symptomatic neurocysticercosis in rural areas in Tanzania and Zambia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
63 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. Resolution of lesions

    The number of active cysts identified by CT scan after treatment

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

  2. Symptom/sign frequency

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

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

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

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

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

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Study locations

1 site
  • National Institute of Medical Research
    Dar Es Salaam, Tanzania
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References and documents

Publications

  • 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 antiparasitic therapy for neurocysticercosis in rural Tanzania: a prospective cohort study. Infection. 2023 Aug;51(4):1127-1139. doi: 10.1007/s15010-023-02021-y. Epub 2023 Mar 24. PubMed 36961623 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2019 to primary completion in Jan 2022, 33 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2019
First posted
Feb 7, 2019
StartActual
Apr 1, 2019
Primary completionActual
Jan 31, 2022
CompletionActual
Jan 31, 2022
Last update
Nov 30, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03834337
Collaborators
National Institute for Medical Research, Tanzania, University of Zambia, Sokoine University of Agriculture
Responsible party
Sponsor
First posted
Feb 7, 2019
Start date
Apr 1, 2019
Primary completion
Jan 31, 2022
Completion
Jan 31, 2022
Last update
Nov 30, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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