LoiasisPhase 2/3STOP-FiLARNCT06252961
A 3- to 5-day Clinical Trial of Levamisole in Loiasis Infected Subjects
A Phase 2/3 study testing Levamisole 3 days and Levamisole 5 days in people with Loiasis, run by Programme National de Lutte contre l'Onchocercose, Republic of the Congo at 2 sites in Republic of the Congo.
Trial summary
The aim of the study is to evaluate the safety and efficacy of a 3- and 5-day course of levamisole (2.5 mg/kg) in management of loiasis microfilaremia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Loiasis
- What is being tested?
- Levamisole 3 days and Levamisole 5 days
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 2 sitesRepublic of the Congo
- Study dates
- 21 Jun 2024to 1 Feb 2026
- Phase
- Phase 2/3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent informed, written, signed and dated
- Women or men aged 18 to 65 years inclusive
- Carrier of L. loa microfilaremia
- Body weight ≥ 40 kg in women and ≥ 45 kg in men; and less than 90 kg
- In good health, as determined by medical questionnaire and general clinical examination
- Absence of acute or chronic infection :
Who cannot join
- Participation in any study other than a purely observational study, within the 4 weeks preceding this study (determined by the theoretical date of the first administration of levamisole or placebo)
- Any vaccination within 4 weeks previous to this study
- Infection requiring treatment in the 10 days previous to this study, as determined by the anamnesis during the medical interview (e.g. pulmonary infection , digestive or skin infection; with or without antibiotic treatment)
- Treatment with clozapine, phenothiazines, sulfasalazine, carbamazepine, synthetic antithyroid drugs, ticlopidine, cimetidine, and gold salts: whether it was long-term treatment, or treatment given as a single dose 10 days before the start of treatment for the clinical trial (precaution with regard to the risk of agranulocytosis of immuno-allergic or toxic origin)
- Known immunosuppressive pathology (by self-report)
- Past or present history of neurological (including epilepsy) or neuropsychiatric disease
Show all 14Show fewer
- History of agranulocytosis
- Use of cocaine or other drugs of abuse in the 72 hours preceding administration of the trial treatment, as determined by history during the medical interview
- Any condition, in the opinion of the investigator, that exposes the subject to undue risk
- Known intolerance to levamisole
- Subjects who donated blood in the previous 8 weeks to study entry, with a standard volume (> 500 mL)
- On clinical examination: symptoms, physical signs or laboratory findings suggestive of systemic disorders, including disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other abnormalities that could interfere with the interpretation of trial results. The physician may then give a favorable or unfavorable opinion on the participant's inclusion.
- Ivermectin and/or levamisole taken in the last six months; and/or mebendazole or albendazole taken in the last month
- Pregnant and/or breast-feeding women
Trial locations and contacts
2 sites in 1 country.
Bachiratou SAHM contact
Republic of the Congo2 sites, 2 recruiting
- Recruiting
Supervisor
Sibiti, Komono
Marlhand HEMILEMBOLO, +242 69781411
- Recruiting
General Supervisor
Sibiti, Mokassi
François MISSAMOU, +242 66680563
About this study
Official title: Randomized, Double-blind Trial Evaluating the Safety and Efficacy of a 3- or 5- Day Course of Levamisole 2.5 mg/kg in Subjects With Loa Loa Microfilaremia
The aim of the study is to evaluate the safety and efficacy of a 3- and 5-day course of levamisole (2.5 mg/kg) in management of loiasis microfilaremia.
Read the detailed description
Onchocerciasis and loiasis are parasitic diseases caused by Onchocerca volvulus and Loa loa, respectively.
Onchocerciasis is endemic in 31 African countries, parts of South America, and Yemen, affecting around 37 million people, while loiasis is present in Central Africa, infecting approximately 15 million individuals. Both diseases are associated with severe complications and increased mortality.
African countries have implemented mass drug administration (MDA) programs using ivermectin to combat onchocerciasis. However, co-endemic loiasis poses challenges due to the risk of severe adverse events. Current strategies involve alternative treatments and chemoprophylaxis to accelerate onchocerciasis elimination. The project aims to evaluate the use of levamisole as an alternative treatment.
This project will assess the safety and efficacy of administering levamisole for 3 and 5 days to reduce Loa microfilarial density. Previous research demonstrated the safety of a single dose of levamisole but indicated the need for longer treatment regimens to achieve a significant reduction in Loa microfilarial density. The project aims to test whether 3- and 5-day levamisole regimens induce an acceptable safety profile and a stronger reduction in Loa microfilarial density.
- Conditions
- Loiasis
- Being tested
- Levamisole 3 days, Levamisole 5 days, Placebo
- Keywords
- Onchocerciasis, Filariasis, Levamisole
- Medical subject headings
- Loiasis, Onchocerciasis, Filariasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levamisole 3 daysDrug
Levamisole for 3 days (2,5 mg/kg) then placebo for 2 days
Levamisole 5 daysDrug
Levamisole for 5 days (2,5 mg/kg)
PlaceboDrug
Placebo for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Levamisole 3 days | Experimental | Participants randomized in this arm will receive 3 days of levamisole 2.5mg/kg, followed by 2 days of placebo Receives: Drug: Levamisole 3 days |
| Levamisole 5 days | Experimental | Participants randomized in this arm will receive a 5-day course of levamisole 2.5mg/kg Receives: Drug: Levamisole 5 days |
| Placebo | Placebo comparator | Participants randomized in this arm will receive 5 days of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of multiple doses of levamisole 2.5 mg/kg in individuals with Loa loa microfilaremia
The proportions of adverse reactions and severe adverse reactions between the three arms of study will be compared, as well as between each interventional arm versus placebo, using appropriate comparative tests A multivariate analysis may be envisaged to assess the influence of age, gender and the presence or absence of M. perstans on the proportion of AEs
Measured: During the treatment (5 days) and 2 weeks after
Secondary outcomes (1)
Efficacy of multiple doses of levamisole 2.5 mg/kg on Loa loa microfilaremia
Microfilaremia reduction rates will be compared between arms at Day 3, Day 5, Day 7, Day 15 and Day 30. The proportions of subjects who had reduced their microfiflaremia by at least 80% at D3, D5, D7, D15 and D30 will be compared Finally, a multivariate analysis could be carried out to assess the influence of age, gender and the presence or absence of M. perstans on the reduction of the microfilaremia.
Measured: From Day 3 after the first dose to Day 30 after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start21 Jun 2024
- Primary completion18 Sep 2024 (estimated)
- Study completion1 Feb 2026 (estimated)
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 LoiasisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 3-group, randomized, double-blind, parallel clinical trial: * Levamisole 2.5 mg for 3 days (followed by 2 days placebo), * Levamisole 2.5 mg for 5 days, * Placebo for 5 days.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Programme National de Lutte contre l'Onchocercose, Republic of the Congo
- Sponsor type
- Other government
- Collaborators
- Institut de Recherche pour le Developpement
- Responsible party
- Sponsor
- Investigators
- Jéremy CAMPILLO, PharmD PhD, Study director, Institut de Recherche pour le Développement (IRD)François MISSAMOU, MD, Principal investigator, Programme National de Lutte contre l'Onchocercose (PNLO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252961
- Sponsor's protocol ID
- Protocole128
- Acronym
- STOP-FiLAR
- Status last verified
- Sep 2024
- First submitted
- 22 Jan 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chesnais CB, Hemilembolo MC, Sahm BA, Toutin F, Djeutassong E, Nga-Elomo N, Cuer B, Ntsiba-N'Goulou MA, Pakat M, Pion SDS, Missamou F, Boussinesq M, Campillo JT. Safety and efficacy of 3- and 5-day regimens of levamisole in loiasis: a randomized, placebo-controlled, double-blind clinical trial. Nat Commun. 2025 Jul 4;16(1):6191. doi: 10.1038/s41467-025-61479-6.
PubMed 40615414
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Trial Evaluating the Safety and Efficacy of a 3- or 5- Day Course of Levamisole 2.5 mg/kg in Subjects With Loa Loa Microfilaremia
- ClinicalTrials.gov ID
- NCT06252961
- Acronym / sponsor ID
- STOP-FiLAR / Protocole128
- Conditions
- Loiasis
- Keywords
- Onchocerciasis, Filariasis, Levamisole
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Programme National de Lutte contre l'Onchocercose, Republic of the CongoOther government
- Collaborators
- Institut de Recherche pour le Developpement
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 18 Sep 2024 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 12 Feb 2024 (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.
The aim of the study is to evaluate the safety and efficacy of a 3- and 5-day course of levamisole (2.5 mg/kg) in management of loiasis microfilaremia.
Detailed description
Onchocerciasis and loiasis are parasitic diseases caused by Onchocerca volvulus and Loa loa, respectively.
Onchocerciasis is endemic in 31 African countries, parts of South America, and Yemen, affecting around 37 million people, while loiasis is present in Central Africa, infecting approximately 15 million individuals. Both diseases are associated with severe complications and increased mortality.
African countries have implemented mass drug administration (MDA) programs using ivermectin to combat onchocerciasis. However, co-endemic loiasis poses challenges due to the risk of severe adverse events. Current strategies involve alternative treatments and chemoprophylaxis to accelerate onchocerciasis elimination. The project aims to evaluate the use of levamisole as an alternative treatment.
This project will assess the safety and efficacy of administering levamisole for 3 and 5 days to reduce Loa microfilarial density. Previous research demonstrated the safety of a single dose of levamisole but indicated the need for longer treatment regimens to achieve a significant reduction in Loa microfilarial density. The project aims to test whether 3- and 5-day levamisole regimens induce an acceptable safety profile and a stronger reduction in Loa microfilarial density.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A 3-group, randomized, double-blind, parallel clinical trial: * Levamisole 2.5 mg for 3 days (followed by 2 days placebo), * Levamisole 2.5 mg for 5 days, * Placebo for 5 days.
| Arm | Type | Receives |
|---|---|---|
| Levamisole 3 days | Experimental | Drug: Levamisole 3 daysParticipants randomized in this arm will receive 3 days of levamisole 2.5mg/kg, followed by 2 days of placebo |
| Levamisole 5 days | Experimental | Drug: Levamisole 5 daysParticipants randomized in this arm will receive a 5-day course of levamisole 2.5mg/kg |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomized in this arm will receive 5 days of placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Consent informed, written, signed and dated
- Women or men aged 18 to 65 years inclusive
- Carrier of L. loa microfilaremia
- Body weight ≥ 40 kg in women and ≥ 45 kg in men; and less than 90 kg
- In good health, as determined by medical questionnaire and general clinical examination
Key exclusion criteria (14 listed)
- Participation in any study other than a purely observational study, within the 4 weeks preceding this study (determined by the theoretical date of the first administration of levamisole or placebo)
- Any vaccination within 4 weeks previous to this study
- Infection requiring treatment in the 10 days previous to this study, as determined by the anamnesis during the medical interview (e.g. pulmonary infection , digestive or skin infection; with or without antibiotic treatment)
- Treatment with clozapine, phenothiazines, sulfasalazine, carbamazepine, synthetic antithyroid drugs, ticlopidine, cimetidine, and gold salts: whether it was long-term treatment, or treatment given as a single dose 10 days before the start of treatment for the clinical trial (precaution with regard to the risk of agranulocytosis of immuno-allergic or toxic origin)
- Known immunosuppressive pathology (by self-report)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levamisole 3 daysLevamisole for 3 days (2,5 mg/kg) then placebo for 2 days | Drug | Levamisole 3 days |
| Levamisole 5 daysLevamisole for 5 days (2,5 mg/kg) | Drug | Levamisole 5 days |
| PlaceboPlacebo for 5 days | Drug | Placebo |
Primary outcome
Tolerance of multiple doses of levamisole 2.5 mg/kg in individuals with Loa loa microfilaremia
Time frame: During the treatment (5 days) and 2 weeks after
The proportions of adverse reactions and severe adverse reactions between the three arms of study will be compared, as well as between each interventional arm versus placebo, using appropriate comparative tests A multivariate analysis may be envisaged to assess the influence of age, gender and the presence or absence of M. perstans on the proportion of AEs
1 secondary outcome
Efficacy of multiple doses of levamisole 2.5 mg/kg on Loa loa microfilaremia
Time frame: From Day 3 after the first dose to Day 30 after the first dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Derived from this study: PubMed 40615414Chesnais CB, Hemilembolo MC, Sahm BA, Toutin F, Djeutassong E, Nga-Elomo N, Cuer B, Ntsiba-N'Goulou MA, Pakat M, Pion SDS, Missamou F, Boussinesq M, Campillo JT. Safety and efficacy of 3- and 5-day regimens of levamisole in loiasis: a randomized, placebo-controlled, double-blind clinical trial. Nat Commun. 2025 Jul 4;16(1):6191. doi: 10.1038/s41467-025-61479-6.
- Individual participant dataSharing planned: No
Related trials for Loiasis
Not yet recruitingPhase 3
21-day Double-blind Trial of Albendazole in Adults With Loa Loa Microfilaremia
Loiasis With Positive Blood Microfilaremia, Loiasis
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.
Bachiratou SAHM contact
Jéremy CAMPILLO, PharmD PhD study director
Institut de Recherche pour le Développement (IRD)
François MISSAMOU, MD principal investigator
Programme National de Lutte contre l'Onchocercose (PNLO)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Levamisole 3 days and Levamisole 5 days in people with Loiasis, run by Programme National de Lutte contre l'Onchocercose, Republic of the Congo at 2 sites in Republic of the Congo.
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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Republic of the Congo. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jéremy CAMPILLO, PharmD PhD (+33 4 67 41 61 52, jeremy.campillo@ird.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance of multiple doses of levamisole 2.5 mg/kg in individuals with Loa loa microfilaremia (time frame: During the treatment (5 days) and 2 weeks after). 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 NCT06252961, 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 20 Sep 2024.