Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-02-26 @ 7:24 PM
Study NCT ID:
NCT03244735
Status:
COMPLETED
Last Update Posted:
2017-08-14
First Post:
2017-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: a Prospective Case Series
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076107', 'term': 'Diet, High-Protein Low-Carbohydrate'}], 'ancestors': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000073600', 'term': 'Diet, High-Protein'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Case series'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-10', 'studyFirstSubmitDate': '2017-08-05', 'studyFirstSubmitQcDate': '2017-08-05', 'lastUpdatePostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attack frequency', 'timeFrame': '3 months', 'description': 'Reduction of at least 50% of number of attacks per month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketogenic Diet'], 'conditions': ['Chronic Cluster Headache']}, 'referencesModule': {'references': [{'pmid': '28132289', 'type': 'BACKGROUND', 'citation': 'Di Lorenzo C, Coppola G, Sirianni G, Rossi P, Pierelli F. O045. Cluster headache improvement during Ketogenic Diet. J Headache Pain. 2015 Dec;16(Suppl 1):A99. doi: 10.1186/1129-2377-16-S1-A99. No abstract available.'}, {'pmid': '29483892', 'type': 'DERIVED', 'citation': 'Di Lorenzo C, Coppola G, Di Lenola D, Evangelista M, Sirianni G, Rossi P, Di Lorenzo G, Serrao M, Pierelli F. Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: An Open-Label, Single-Arm, Clinical Trial. Front Neurol. 2018 Feb 12;9:64. doi: 10.3389/fneur.2018.00064. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Atkins diet is a nutritional regimen characterized by ad libitum protein and fat intake, but carbohydrate restriction. It is followed by millions of people around the word as a life-style, but in the last years was proposed as a treatment for the epilepsy, by its capacity to induce the state of ketosis.\n\nSince Authors observed that ketosis could be also useful in migraine, and migraine shares some pathophysiological features with cluster headache, The aim of the study is to test the efficacy of Atkins diet in Cluster Headache by an open label one harm observational study.', 'detailedDescription': 'The Atkins diet is a ketogenic high-fat, low-carbohydrate diet for long adopted as lifestyle by people that dislike have an high carbohydrate intake. This nutritional life style seems to account for more energy in the daily activity and an easy weight control. In the last years, researchers showed that a modified Atkins diet (MAD) can be useful to treat drug resistant epilepsy, maybe by the induction of ketogenesis.\n\nKetogenesis, ketone-body formation, is a physiologic phenomenon also observed in patients following low-carbohydrate high fat diets. Different Authors evidenced a protective effect of ketone bodies also on migraine that shares some pathophysiological features with cluster headache (CH).\n\nCH is the worst form of headache, also called as "suicide headache"; in particular its unremitting form, called Chronic CH (CCH) is regarded as a clinical challenge for neurologist, if refractory to pharmacological treatments. So far, no data are available about a beneficial effect of ketogenesis in CH. However, the beta hydroxybutyrate (BHB) has a chemical formula similar to gamma hydroxybutyrate (GHB) that has shown to be effective in CH. Moreover, ketosis has also a beneficial effect on hypothalamic dysfunctions that are shared by some form of epilepsy and CH.\n\nAim of this study is verify in an open label observational study if a MAD can be useful in the treatment of CCH. In case of positive outcome, the results could be used as preliminary data to design a double blind versus placebo study, to asses definitively if ketogenesis is really able to prevent/avoid headache attacks in CH.\n\nMethods: By the Italian branch of the Organization for the Understanding of Cluster Headache (OUCH), there will be recruited CCH volunteers that accept to modify their diet according to Atkins Diet for at least three months.\n\nHeadache attack frequency will be collected on specific headache-calendars and a comparison between the pre-diet phase and the during-the-diet- phase will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of CCH (less than 30 consecutive days of attacks remission in the last year)\n* kept a headache diary for at least 1 month\n* CH onset before the age of 50\n\nExclusion Criteria:\n\n* over consumption of acute pain-killers (triptan, analgesic, or ergotamine)\n* pregnancy or lactation\n* type I diabetes\n* serious organic or psychiatric disorders that the investigators judged as having the potential to influence the trial evaluation.'}, 'identificationModule': {'nctId': 'NCT03244735', 'acronym': 'CCHD', 'briefTitle': 'Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: a Prospective Case Series', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache. A Prospective Case Series', 'orgStudyIdInfo': {'id': 'CCHDiet'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified Atkins Diet (MAD)', 'description': 'CCH patients that follows at least 3 months of MAD', 'interventionNames': ['Other: Atkins diet']}], 'interventions': [{'name': 'Atkins diet', 'type': 'OTHER', 'description': 'A nutritional regimen characterized by high fat low carbohydrate intake.', 'armGroupLabels': ['Modified Atkins Diet (MAD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Rome', 'country': 'Italy', 'facility': 'Policlinico Umberto I', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Francesco Pierelli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sapienza Univeristy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not share data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Fellow', 'investigatorFullName': 'Cherubino DI LORENZO', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}