Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-28 @ 12:14 AM
Study NCT ID:
NCT06619860
Status:
RECRUITING
Last Update Posted:
2025-10-27
First Post:
2024-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2024-09-27', 'studyFirstSubmitQcDate': '2024-09-27', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12', 'timeFrame': 'From Baseline up to Week 12'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants with Greater than or Equal to (≥) 30 Percent (%) Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12', 'timeFrame': 'From Baseline up to Week 12'}, {'measure': 'Proportion of Participants with ≥50% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12', 'timeFrame': 'From Baseline up to Week 12'}, {'measure': 'Proportion of Participants with ≥70% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12', 'timeFrame': 'From Baseline up to Week 12'}, {'measure': 'Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 up to Week 16'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Peripheral Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety, and tolerability of VX-993 in participants with pain associated with Diabetic Peripheral Neuropathy (DPN)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus type 1 or type 2 with\n\n * Glycosylated hemoglobin A1c (HbA1c) less than or equal to (≤) 9% and\n * Presence of bilateral pain in lower extremities due to DPN (defined as a symmetric, length-dependent sensory or sensorimotor polyneuropathy) for at least 1 year\n\nKey Exclusion Criteria:\n\n* Painful neuropathy other than DPN\n* History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)\n* History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months\n\nOther protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06619860', 'briefTitle': 'Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of Oral VX-993 in Subjects With Pain Associated With Diabetic Peripheral Neuropathy', 'orgStudyIdInfo': {'id': 'VX24-993-103'}, 'secondaryIdInfos': [{'id': '2024-514689-38-01', 'type': 'OTHER', 'domain': 'EU Trial (CTIS) Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VX-993', 'description': 'Participants will be randomized to receive multiple doses of different dose levels of VX-993.', 'interventionNames': ['Drug: VX-993', 'Drug: Placebo (matched to pregabalin)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabalin', 'description': 'Participants will be randomized to receive Pregabalin.', 'interventionNames': ['Drug: Pregabalin', 'Drug: Placebo (matched to VX-993)']}], 'interventions': [{'name': 'VX-993', 'type': 'DRUG', 'description': 'Tablets for oral administration.', 'armGroupLabels': ['VX-993']}, {'name': 'Pregabalin', 'type': 'DRUG', 'description': 'Capsules for oral administration.', 'armGroupLabels': ['Pregabalin']}, {'name': 'Placebo (matched to pregabalin)', 'type': 'DRUG', 'description': 'Placebo matched to pregabalin for oral administration.', 'armGroupLabels': ['VX-993']}, {'name': 'Placebo (matched to VX-993)', 'type': 'DRUG', 'description': 'Placebo matched to VX-993 for oral administration.', 'armGroupLabels': ['Pregabalin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35055', 'city': 'Cullman', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cullman Clinical Trials', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Trovare Clinical Research - Bakersfield CA', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '91942', 'city': 'La Mesa', 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