Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-01-01 @ 6:44 PM
Study NCT ID:
NCT06252961
Status:
RECRUITING
Last Update Posted:
2024-09-20
First Post:
2024-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 3- to 5-day Clinical Trial of Levamisole in Loiasis Infected Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008118', 'term': 'Loiasis'}, {'id': 'D009855', 'term': 'Onchocerciasis'}, {'id': 'D005368', 'term': 'Filariasis'}], 'ancestors': [{'id': 'D017205', 'term': 'Spirurida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012876', 'term': 'Skin Diseases, Parasitic'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007978', 'term': 'Levamisole'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A 3-group, randomized, double-blind, parallel clinical trial:\n\n* Levamisole 2.5 mg for 3 days (followed by 2 days placebo),\n* Levamisole 2.5 mg for 5 days,\n* Placebo for 5 days.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 99}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-18', 'studyFirstSubmitDate': '2024-01-22', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerance of multiple doses of levamisole 2.5 mg/kg in individuals with Loa loa microfilaremia', 'timeFrame': 'During the treatment (5 days) and 2 weeks after', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Efficacy of multiple doses of levamisole 2.5 mg/kg on Loa loa microfilaremia', 'timeFrame': 'From Day 3 after the first dose to Day 30 after the first dose', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Onchocerciasis', 'Filariasis', 'Levamisole'], 'conditions': ['Loiasis']}, 'referencesModule': {'references': [{'pmid': '40615414', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Onchocerciasis and loiasis are parasitic diseases caused by Onchocerca volvulus and Loa loa, respectively.\n\nOnchocerciasis 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.\n\nAfrican 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Consent informed, written, signed and dated\n* Women or men aged 18 to 65 years inclusive\n* Carrier of L. loa microfilaremia\n* Body weight ≥ 40 kg in women and ≥ 45 kg in men; and less than 90 kg\n* In good health, as determined by medical questionnaire and general clinical examination\n* Absence of acute or chronic infection :\n\nExclusion criteria\n\n* 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)\n* Any vaccination within 4 weeks previous to this study\n* 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)\n* 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)\n* Known immunosuppressive pathology (by self-report)\n* Past or present history of neurological (including epilepsy) or neuropsychiatric disease\n* History of agranulocytosis\n* 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\n* Any condition, in the opinion of the investigator, that exposes the subject to undue risk\n* Known intolerance to levamisole\n* Subjects who donated blood in the previous 8 weeks to study entry, with a standard volume (\\> 500 mL)\n* 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.\n* Ivermectin and/or levamisole taken in the last six months; and/or mebendazole or albendazole taken in the last month\n* Pregnant and/or breast-feeding women"}, 'identificationModule': {'nctId': 'NCT06252961', 'acronym': 'STOP-FiLAR', 'briefTitle': 'A 3- to 5-day Clinical Trial of Levamisole in Loiasis Infected Subjects', 'organization': {'class': 'OTHER_GOV', 'fullName': "Programme National de Lutte contre l'Onchocercose, Republic of the Congo"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Protocole128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levamisole 3 days', 'description': 'Participants randomized in this arm will receive 3 days of levamisole 2.5mg/kg, followed by 2 days of placebo', 'interventionNames': ['Drug: Levamisole 3 days']}, {'type': 'EXPERIMENTAL', 'label': 'Levamisole 5 days', 'description': 'Participants randomized in this arm will receive a 5-day course of levamisole 2.5mg/kg', 'interventionNames': ['Drug: Levamisole 5 days']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants randomized in this arm will receive 5 days of placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Levamisole 3 days', 'type': 'DRUG', 'description': 'Levamisole for 3 days (2,5 mg/kg) then placebo for 2 days', 'armGroupLabels': ['Levamisole 3 days']}, {'name': 'Levamisole 5 days', 'type': 'DRUG', 'description': 'Levamisole for 5 days (2,5 mg/kg)', 'armGroupLabels': ['Levamisole 5 days']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for 5 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sibiti', 'state': 'Komono', 'status': 'RECRUITING', 'country': 'Republic of the Congo', 'contacts': [{'name': 'Marlhand HEMILEMBOLO', 'role': 'CONTACT', 'phone': '+242 69781411'}], 'facility': 'Supervisor', 'geoPoint': {'lat': -3.68192, 'lon': 13.34985}}, {'city': 'Sibiti', 'state': 'Mokassi', 'status': 'RECRUITING', 'country': 'Republic of the Congo', 'contacts': [{'name': 'François MISSAMOU', 'role': 'CONTACT', 'phone': '+242 66680563'}], 'facility': 'General Supervisor', 'geoPoint': {'lat': -3.68192, 'lon': 13.34985}}], 'centralContacts': [{'name': 'Jéremy CAMPILLO, PharmD PhD', 'role': 'CONTACT', 'email': 'jeremy.campillo@ird.fr', 'phone': '+33 4 67 41 61 52'}, {'name': 'Bachiratou SAHM', 'role': 'CONTACT', 'email': 'bachiratou.sahm@ird.fr'}], 'overallOfficials': [{'name': 'Jéremy CAMPILLO, PharmD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut de Recherche pour le Développement (IRD)'}, {'name': 'François MISSAMOU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Programme National de Lutte contre l'Onchocercose (PNLO)"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Programme National de Lutte contre l'Onchocercose, Republic of the Congo", 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Institut de Recherche pour le Developpement', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}