Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-03-08 @ 11:01 PM
Study NCT ID:
NCT06540651
Status:
RECRUITING
Last Update Posted:
2025-03-17
First Post:
2024-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Light Therapy in Treatment of Chronic Cluster Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003027', 'term': 'Cluster Headache'}], 'ancestors': [{'id': 'D051303', 'term': 'Trigeminal Autonomic Cephalalgias'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-05-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2024-08-02', 'studyFirstSubmitQcDate': '2024-08-02', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The median weekly number of cluster headache attacks', 'timeFrame': 'At day 28', 'description': 'The difference in the median weekly number of cluster headache attacks between the month prior to randomization and the month of the double-blind period, between the two arms.'}], 'secondaryOutcomes': [{'measure': 'Incidence and nature of adverse reactions', 'timeFrame': 'Daily', 'description': 'Headache, eye fatigue, dry eyes, nausea'}, {'measure': 'Intensity of cluster headache', 'timeFrame': 'Daily', 'description': 'mild, moderate, severe, very severe'}, {'measure': 'Use of acute treatments', 'timeFrame': 'Daily', 'description': 'sumatriptan and oxygen therapy'}, {'measure': "Patient's Global Impression of Change (PGIC) score", 'timeFrame': 'At day 28', 'description': 'From better outcome, score 1 (Highly improved) to worse outcome, score 7 (Highly aggravated)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cluster Headache']}, 'descriptionModule': {'briefSummary': 'Cluster headache is a primary headache. The chronic form of the disease is often difficult to treat. It is now considered a chronobiological disease. This chronobiological character is based on clinical, biological and radiological arguments.\n\nThis study focuses on the use of light therapy in cluster headache. Light therapy has already been used in the treatment of other chronobiological diseases, such as seasonal depression, but also recently in the therapy of other primary headaches (such as migraine). Its aim is to re-adjust chronobiological rhythms, and it therefore seems worth testing in the chronic form of cluster headache.\n\nLight therapy is delivered to the patient using a consumer electronics device.The main objective is to evaluate the prophylactic efficacy of light therapy in patients with chronic cluster headache.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, of 18 years years old or more;\n* Diagnosis of chronic cluster headache according to ICHD-3 criteria;\n* Number of seizures during baseline equal to at least 24;\n* Stability of prophylactic treatment for at least 1 month and commitment not to change it for the duration of the study;\n* Patient affiliated to the French social security system.\n* Patient who understands and speaks French correctly;\n* Patient who has given free and informed written consent.\n\nExclusion Criteria:\n\n* Contraindication to the use of light therapy: use of a photosensitizing treatment;\n* Ophthalmological history: cataract, macular degeneration, glaucoma, retinitis pigmentosa;\n* Patients who work at night;\n* Other neurological, psychiatric or developmental pathologies considered incompatible with the study;\n* Background treatment of cluster headache with melatonin;\n* Persons protected by articles L1121-5, L1121-6 and L1121-8 of the French Public Health Code (pregnant or breast-feeding women, persons deprived of their liberty by judicial decision, socially vulnerable persons, adults incapable or unable to express their consent).'}, 'identificationModule': {'nctId': 'NCT06540651', 'acronym': 'LUMIAVFc', 'briefTitle': 'Efficacy of Light Therapy in Treatment of Chronic Cluster Headache', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Proof-of-concept Study on the Efficacy of Light Therapy in the Prophylactic Treatment of Chronic Cluster Headache', 'orgStudyIdInfo': {'id': 'RCAPHM23_0463'}, 'secondaryIdInfos': [{'id': '2024-A01453-44', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group (group 1)', 'description': 'Luminette® with active light emission in the 400 \\< X \\< 750 nm spectrum', 'interventionNames': ['Other: use of Luminettes ® with active light emission']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group (group 2)', 'description': 'Luminette ® with modified spectral parameters for wavelengths covered, with light emission in a spectrum of 560 \\< X \\< 650 nm assumed to have no therapeutic effect (placebo effect)', 'interventionNames': ['Other: use of Luminettes ® with a light emission presumed to have no therapeutic effect']}], 'interventions': [{'name': 'use of Luminettes ® with active light emission', 'type': 'OTHER', 'description': 'Spectrum of 400 \\< X \\< 750 nm assumed active', 'armGroupLabels': ['Experimental group (group 1)']}, {'name': 'use of Luminettes ® with a light emission presumed to have no therapeutic effect', 'type': 'OTHER', 'description': 'Modification of spectrum parameters for wavelengths covered, with light emission in a spectrum of 560 \\< X \\< 650 nm assumed to have no therapeutic effect', 'armGroupLabels': ['Control group (group 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13005', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne Donnet', 'role': 'CONTACT', 'email': 'anne.donnet@ap-hm.fr', 'phone': '+33491384345'}], 'facility': 'Hopital La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '06000', 'city': 'Nice', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Michel LANTERI-MINET', 'role': 'CONTACT'}], 'facility': 'Hôpital de Cimiez', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Anne DONNET', 'role': 'CONTACT', 'email': 'anne.donnet@ap-hm.fr', 'phone': '+33491384345'}, {'name': 'Sophie Tardoski', 'role': 'CONTACT', 'email': 'sophie.tardoski@ap-hm.fr', 'phone': '0491381594 Ext. 33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}