NeurocysticercosisTOPANANCT03834337
Treatment of Patients With Active Neurocysticercosis in Eastern Africa
An observational study of Neurocysticercosis, run by Technical University of Munich at 1 site in Tanzania.
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Neurocysticercosis
- How many people
- 63 participants
- Where
- 1 siteTanzania
- Study dates
- 1 Apr 2019to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with active, symptomatic neurocysticercosis in rural areas in Tanzania and Zambia
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Neurocysticercosis
- Medical subject headings
- Neurocysticercosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of lesions
The number of active cysts identified by CT scan after treatment
Measured: Change in number of active cysts from before treatment to six months after treatment termination
Symptom/sign frequency
The percentage of participants who exhibit a neurological symptom/sign of NCC: chronic/severe progressive headache or epileptic seizures.
Measured: Change of symptom/sign frequency from before treatment to six months after treatment termination
Secondary outcomes (3)
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.
Measured: Change in quality of life from before treatment to six months after treatment termination
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.
Measured: Change in quality of life from before treatment to six months after treatment termination
Change in presence of T.solium-specific antigen
Change in presence of T.solium-specific antigen in the blood of patients with active neurocysticercosis
Measured: Change in presence of T.solium-specific antigen from before treatment to six months after treatment termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start1 Apr 2019
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeurocysticercosisStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, University of Zambia, Sokoine University of Agriculture
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834337
- Sponsor's protocol ID
- TOPANA
- Acronym
- TOPANA
- Status last verified
- Nov 2023
- First submitted
- 30 Jan 2019
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03834337
- Acronym / sponsor ID
- TOPANA / TOPANA
- Conditions
- Neurocysticercosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, University of Zambia, Sokoine University of Agriculture
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with active, symptomatic neurocysticercosis in rural areas in Tanzania and Zambia
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
3 secondary outcomes
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
Health-related Quality of Life (epileptic patients)
Time frame: Change in quality of life from before treatment to six months after treatment termination
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Results publication: PubMed 36961623Stelzle 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.
- Efficacy and safety of antiparasitic therapy for neurocysticercosis in rural Tanzania: a prospective cohort studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocysticercosis, run by Technical University of Munich at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of lesions (time frame: Change in number of active cysts from before treatment to six months after treatment termination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03834337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.