Onchocerciasis, OcularPhase 2EOLoaNCT04049630
Clinical Trial Evaluating the Safety and Efficacy of Levamisole in Loa Loa Microfilaremic Patients
A Phase 2 study testing LEV 1 mg/kg, LEV 1,5 mg/kg and LEV 2,5 mg/kg in people with Onchocerciasis, Ocular and Loiasis, run by Programme National de Lutte contre l'Onchocercose, Republic of the Congo at 1 site in Republic of the Congo.
Trial summary
This study aims at evaluating the safety and efficacy of levamisole in patients with loiasis infection. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Onchocerciasis, Ocular, Loiasis
- What is being tested?
- LEV 1 mg/kg, LEV 1,5 mg/kg and LEV 2,5 mg/kg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 1 siteRepublic of the Congo
- Study dates
- 16 Jan 2021to 15 Jul 2021
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written consent written, signed (or with thumbprint) and dated
- Aged 18 to 65 inclusive
- Individual microfilarial density ≥ 1mf/mL
- Body weight ≥ 40 kg in women and ≥ 45 kg in men; and less than 85 kg
- In good health condition, as determined by the medical questionnaire and the general clinical examination: absence of acute or chronic infection
Who cannot join
- Participation in any study other than purely observational, in the 4 weeks preceding this study (determined by the theoretical date of administration of LEV or placebo).
- Any vaccination in the 4 weeks preceding this study.
- Acute infection requiring a treatment in the 10 days preceding this study, determined by the anamnesis during the medical interview (example: pulmonary infection, ENT, digestive, cutaneous, with implementation of an antibiotic treatment or not)
- Warfarin treatment
- Treatment with clozapine, phenythiazines, sulfasalazine, carbamazepine, synthetic antithyroid, ticlopidine, cimetidine, and gold salts: whether it is a long-term treatment, or a treatment given in a single dose 10 days before the start of treatment for the clinical trial (precaution of use compared to the risk of agranulocytosis of immuno-allergic or toxic origin)
- Known immunosuppressive pathology
Show all 15Show fewer
- Past or current history of neurological (including epilepsy) or neuropsychiatric disease
- History of agranulocytosis
- Consumption of alcohol, taking cocaine or other drugs of abuse in the 72 hours preceding the administration of the treatment of the test determined by the anamnesis during the medical interview
- Any condition, in the opinion of the investigator, which exposes the subject to an undue risk
- Known intolerance to levamisole
- Subjects who gave blood in the 8 weeks before entry into the study, with a standard volume (> 500 mL)
- During the clinical examination: symptoms, physical signs or biological constants suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, cutaneous, immunodeficiency, psychiatric disorders and other abnormalities likely to interfere with the interpretation results of the test. The doctor may then give a favorable or unfavorable opinion for the inclusion of the participant
- Taking IVM and / or LEV during the last six months; and / or mebendazole or albendazole in the last month
- Pregnant and lactating women (based on self-declaration)
Trial locations and contacts
1 site in 1 country.
Republic of the Congo1 site
Secteur opérationnelle de la Santé, Ministère de la Santé et de la Population
Sibiti
About this study
Official title: Randomized Clinical Trial, Double-blind, Dose-escalating of Drug Intensities, Evaluating the Safety and Efficacy of Levamisole in Loa Loa Microfilaremic Patients
This study aims at evaluating the safety and efficacy of levamisole in patients with loiasis infection.
Read the detailed description
This clinical trial will be conducted in Republic of Congo. This is a pragmatic and adaptative randomized, double-blind clinical trial. Levamisole will be tested at 1 and 1,5 mg/kg, and compared to placebo (36:36:36); or 2,5 mg/kg compared to placebo (36:36) in case of adaptation of the dose for cohorts II and III.
We will perform three cohorts of patients according to the microfilarial density : 1-1,999 mf/ml, 1-14,999 mf/ml, and all microfilaremic individuals; in order to respect the safety potentially related to loiasis.
The first cohort was to evaluate the most appropriate dose of levamisole, with a possibility to increase (to 2.5 mg/kg) the dose of levamisole for the cohorts II and III in case of lack of efficacy and in case of good safety profil.
- Conditions
- Onchocerciasis, Ocular, Loiasis
- Being tested
- LEV 1 mg/kg, LEV 1,5 mg/kg, LEV 2,5 mg/kg, Placebo
- Medical subject headings
- Onchocerciasis, Ocular, Loiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEV 1 mg/kgDrug
A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.
LEV 1,5 mg/kgDrug
A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.
LEV 2,5 mg/kgDrug
A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.
PlaceboDrug
5 tablets of placebo will be administrated to the participants.
| Study group | Role | What they receive |
|---|---|---|
| LEV 1 mg/kg | Experimental | Tablets of LEV at 1 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant. Receives: Drug: LEV 1 mg/kg; Drug: Placebo |
| LEV 1,5 mg/kg | Experimental | Tablet of LEV at 1,5 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant. Receives: Drug: LEV 1,5 mg/kg; Drug: Placebo |
| LEV 2,5 mg/kg | Experimental | Tablet of LEV at 2,5 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant. Receives: Drug: LEV 2,5 mg/kg; Drug: Placebo |
| Placebo | Placebo comparator | Tablets of placebo will be administrated to the participant in single dose only one time. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of levamisole
Absence of severe adverse events during the first week
Measured: 1 week
Incidence of adverse events with levamisole
Proportion of adverse events during the first week
Measured: 1 week
Secondary outcomes (2)
Efficacy of levamisole
Proportion of reduction of the microfilarial density of Loa loa at Day 2, Day 7, and Month 1
Measured: Day 2, Day 7, and Month 1
Proportion of individuals without microfilariae of Loa loa
Proportion of individuals with a diminution of 40% and 80% and more of the microfilarial density at Day 7 and Month 1
Measured: Day 7 and 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start16 Jan 2021
- Primary completion24 Apr 2021
- Study completion15 Jul 2021
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 Onchocerciasis, OcularStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Programme National de Lutte contre l'Onchocercose, Republic of the Congo
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049630
- Sponsor's protocol ID
- EOLoa/LEV
- Acronym
- EOLoa
- Status last verified
- Sep 2021
- First submitted
- 26 Jul 2019
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Campillo JT, Bikita P, Hemilembolo M, Louya F, Missamou F, Pion SDS, Boussinesq M, Chesnais C. Safety and Efficacy of Levamisole in Loiasis: A Randomized, Placebo-controlled, Double-blind Clinical Trial. Clin Infect Dis. 2022 Aug 24;75(1):19-27. doi: 10.1093/cid/ciab906.
PubMed 34651190
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial, Double-blind, Dose-escalating of Drug Intensities, Evaluating the Safety and Efficacy of Levamisole in Loa Loa Microfilaremic Patients
- ClinicalTrials.gov ID
- NCT04049630
- Acronym / sponsor ID
- EOLoa / EOLoa/LEV
- Conditions
- Onchocerciasis, Ocular, Loiasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Programme National de Lutte contre l'Onchocercose, Republic of the CongoOther government
- Study start
- 16 Jan 2021 (actual)
- Primary completion
- 24 Apr 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 8 Aug 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 study aims at evaluating the safety and efficacy of levamisole in patients with loiasis infection.
Detailed description
This clinical trial will be conducted in Republic of Congo. This is a pragmatic and adaptative randomized, double-blind clinical trial. Levamisole will be tested at 1 and 1,5 mg/kg, and compared to placebo (36:36:36); or 2,5 mg/kg compared to placebo (36:36) in case of adaptation of the dose for cohorts II and III.
We will perform three cohorts of patients according to the microfilarial density : 1-1,999 mf/ml, 1-14,999 mf/ml, and all microfilaremic individuals; in order to respect the safety potentially related to loiasis.
The first cohort was to evaluate the most appropriate dose of levamisole, with a possibility to increase (to 2.5 mg/kg) the dose of levamisole for the cohorts II and III in case of lack of efficacy and in case of good safety profil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LEV 1 mg/kg | Experimental | Drug: LEV 1 mg/kg, Drug: PlaceboTablets of LEV at 1 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant. |
| LEV 1,5 mg/kg | Experimental | Drug: LEV 1,5 mg/kg, Drug: PlaceboTablet of LEV at 1,5 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant. |
| LEV 2,5 mg/kg | Experimental | Drug: LEV 2,5 mg/kg, Drug: PlaceboTablet of LEV at 2,5 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant. |
| Placebo | Placebo comparator | Drug: PlaceboTablets of placebo will be administrated to the participant in single dose only one time. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written consent written, signed (or with thumbprint) and dated
- Aged 18 to 65 inclusive
- Individual microfilarial density ≥ 1mf/mL
- Body weight ≥ 40 kg in women and ≥ 45 kg in men; and less than 85 kg
- In good health condition, as determined by the medical questionnaire and the general clinical examination: absence of acute or chronic infection
Key exclusion criteria (15 listed)
- Participation in any study other than purely observational, in the 4 weeks preceding this study (determined by the theoretical date of administration of LEV or placebo).
- Any vaccination in the 4 weeks preceding this study.
- Acute infection requiring a treatment in the 10 days preceding this study, determined by the anamnesis during the medical interview (example: pulmonary infection, ENT, digestive, cutaneous, with implementation of an antibiotic treatment or not)
- Warfarin treatment
- Treatment with clozapine, phenythiazines, sulfasalazine, carbamazepine, synthetic antithyroid, ticlopidine, cimetidine, and gold salts: whether it is a long-term treatment, or a treatment given in a single dose 10 days before the start of treatment for the clinical trial (precaution of use compared to the risk of agranulocytosis of immuno-allergic or toxic origin)
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 |
|---|---|---|
| LEV 1 mg/kgA combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets. | Drug | LEV 1 mg/kg |
| LEV 1,5 mg/kgA combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets. | Drug | LEV 1,5 mg/kg |
| LEV 2,5 mg/kgA combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets. | Drug | LEV 2,5 mg/kg |
| Placebo5 tablets of placebo will be administrated to the participants. | Drug | LEV 1 mg/kg, LEV 1,5 mg/kg, LEV 2,5 mg/kg, Placebo |
Primary outcome
Safety and tolerability of levamisole
Time frame: 1 week
Absence of severe adverse events during the first week
Incidence of adverse events with levamisole
Time frame: 1 week
Proportion of adverse events during the first week
2 secondary outcomes
Efficacy of levamisole
Time frame: Day 2, Day 7, and Month 1
Proportion of individuals without microfilariae of Loa loa
Time frame: Day 7 and 1 Month
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 20 Sep 2021.
- Derived from this study: PubMed 34651190Campillo JT, Bikita P, Hemilembolo M, Louya F, Missamou F, Pion SDS, Boussinesq M, Chesnais C. Safety and Efficacy of Levamisole in Loiasis: A Randomized, Placebo-controlled, Double-blind Clinical Trial. Clin Infect Dis. 2022 Aug 24;75(1):19-27. doi: 10.1093/cid/ciab906.
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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?
A Phase 2 study testing LEV 1 mg/kg, LEV 1,5 mg/kg and LEV 2,5 mg/kg in people with Onchocerciasis, Ocular and Loiasis, run by Programme National de Lutte contre l'Onchocercose, Republic of the Congo at 1 site 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 5 inclusion and 15 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 20 Sep 2021. 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 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety and tolerability of levamisole (time frame: 1 week). 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 NCT04049630, 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 2021.