Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-03-01 @ 12:51 PM
Study NCT ID:
NCT06324760
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2024-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alpha-lipoic Acid Combined With B Vitamins Shows Promise for Treating Restless Legs Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012148', 'term': 'Restless Legs Syndrome'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014803', 'term': 'Vitamin B Complex'}], 'ancestors': [{'id': 'D014815', 'term': 'Vitamins'}, {'id': 'D018977', 'term': 'Micronutrients'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS)', 'timeFrame': '6 months', 'description': 'This scale contains 10 items, rated from 0 to 4, according to the severity reported by the patient (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.). The cumulative scores are categorized as mild (1-10), moderate (11-20), severe (21-30), and very severe (31-40).'}], 'secondaryOutcomes': [{'measure': 'Anthropometric parameters of the patients.', 'timeFrame': '6 Months', 'description': 'Weight (kg).'}, {'measure': "Patients' body measurements", 'timeFrame': '6 Months', 'description': 'Body mass index (BMI) (kg/m²).'}, {'measure': 'Measurements of patient anatomy', 'timeFrame': '6 Months', 'description': 'Total fat mass (kg).'}, {'measure': "Patients' body characteristics.", 'timeFrame': '6 Months', 'description': 'Visceral fat mass (kg).'}, {'measure': 'Measurements of patient anatomy.', 'timeFrame': '6 Months', 'description': 'Muscle mass (kg).'}]}, 'conditionsModule': {'keywords': ['RLS'], 'conditions': ['Restless Legs Syndrome']}, 'descriptionModule': {'briefSummary': "Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues.", 'detailedDescription': 'Restless legs syndrome, also known as Willis-Ekbom disease, is a neurological disorder characterised by uncomfortable sensations in the legs and an urge to move them. In Spain, its prevalence range is estimated to be between 11.6% - 19.5% in adults, but it is difficult to know due to underdiagnosis. Alpha-lipoic acid (ALA) and B vitamins have emerged as potential treatments due to their roles in reducing oxidative stress and associated vitamin deficiencies. The Tiobec® 400 (T400) supplement combines ALA, B vitamins, E, and C, and its efficacy and safety in alleviating RLS symptoms, along with its impact on anthropometric measures, are under investigation. This study aims to explore therapeutic options for managing RLS, with promising results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The data will be collected from patients who meet the selection criteria.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be a minimum of 18 years of age.\n* They must have a primary diagnosis of RLS without prior therapeutic interventions for the ailment.\n* They need to provide explicit consent via an informed consent document.\n\nExclusion Criteria:\n\n* Patients diagnosed with pathologies other than RLS that affect sleep quality.\n* Those with persistent renal diseases or any other chronic, severe medical condition.'}, 'identificationModule': {'nctId': 'NCT06324760', 'briefTitle': 'Alpha-lipoic Acid Combined With B Vitamins Shows Promise for Treating Restless Legs Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Uriach Consumer Healthcare'}, 'officialTitle': 'Usefulness of Alpha-lipoic Acid Combined With B Vitamins for the Treatment of Restless Legs Syndrome', 'orgStudyIdInfo': {'id': 'LIPOICSPI2018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Alpha-lipoic acid combined with B vitamins', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The investigational product utilized in this research, Tiobec® 400 is a dietary supplement enriched with ALA, B vitamins, and vitamins E and C. T400 is designed to mitigate oxidative stress and support the optimal functioning of the nervous system'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08017', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Medical Center Teknon', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Javier Albares, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Medico Teknon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uriach Consumer Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}