Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT06203002
Status:
COMPLETED
Last Update Posted:
2025-10-10
First Post:
2023-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 'ACTUAL', 'count': 496}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'dispFirstSubmitDate': '2025-08-28', 'completionDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2023-11-30', 'studyFirstSubmitQcDate': '2024-01-02', 'dispFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)', 'timeFrame': 'Baseline, Week 8', 'description': 'ADPS is based on the 11-point numerical rating scale (NRS) \\[0 (no pain) to 10 (worst imaginable pain)\\].'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline to Week 8 in Burning Pain', 'timeFrame': 'Baseline, Week 8', 'description': 'Burning pain is based on the 11-point NRS (0 \\[no burning\\] to 10 \\[worst burning imaginable\\]).'}, {'measure': 'Change from Baseline to Week 8 in Pain Interference on Sleep', 'timeFrame': 'Baseline, Week 8', 'description': 'Pain interference on sleep is based on the 11-point NRS (0 \\[does not interfere\\] to 10 \\[completely interferes\\]).'}, {'measure': 'Patient Global Impression of Change (PGIC) Score at Week 8', 'timeFrame': 'Week 8', 'description': "The PGIC is a 7-point rating scale that assesses a participant's belief about the overall improvement experienced by the participant where 1=very much improved and 7=very much worse."}, {'measure': 'Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score', 'timeFrame': 'Baseline, Week 8', 'description': 'NPSI total score is based on 5 subscales evaluating different symptoms of neuropathic pain, each evaluated on a scale of 0 (no pain) to 10 (worst pain). The total score ranges from 0 to 100. A higher score indicates a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Peripheral Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant has given written informed consent to participate in the study in accordance with local regulations\n2. Adult male and female participants ≥18 years of age at the Screening Visit\n3. Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m\\^2) at Screening\n4. Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening\n5. Pain from DPNP present for at least 6 months prior to Screening\n6. At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%.\n7. Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening\n8. Willing to adhere to the prohibitions and restrictions specified in the protocol.\n\nExclusion Criteria:\n\n1. Presence of other painful conditions that may confound assessment or self-evaluation of DPNP\n2. History of neurolytic or neurosurgical therapy for DPNP\n3. Use of opioid medications for management of DPNP within the 2 months prior to the Screening Visit.\n4. Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathic pain within 3 months prior to Screening\n5. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to Screening'}, 'identificationModule': {'nctId': 'NCT06203002', 'acronym': 'PROGRESS', 'briefTitle': 'A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lexicon Pharmaceuticals'}, 'officialTitle': 'A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study in PatientS With Diabetic Peripheral Neuropathic Pain (PROGRESS)', 'orgStudyIdInfo': {'id': 'LX9211.1-204-DPN'}, 'secondaryIdInfos': [{'id': 'LX9211.204-DPN', 'type': 'OTHER', 'domain': 'Lexicon Pharmaceuticals, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LX9211 Low Dose', 'description': 'LX9211 low dose, orally, once daily during a blinded treatment period.', 'interventionNames': ['Drug: LX9211 (blinded)']}, {'type': 'EXPERIMENTAL', 'label': 'LX9211 High Dose', 'description': 'LX9211 high dose, orally, once daily during a blinded treatment period.', 'interventionNames': ['Drug: LX9211 (blinded)']}, {'type': 'EXPERIMENTAL', 'label': 'LX9211 High Dose Followed by Low Dose', 'description': 'LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.', 'interventionNames': ['Drug: LX9211 (blinded)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'LX9211 Placebo', 'description': 'LX9211 matching placebo, orally, once daily during a blinded treatment period.', 'interventionNames': ['Drug: Placebo (blinded)']}], 'interventions': [{'name': 'Placebo (blinded)', 'type': 'DRUG', 'description': 'LX9211 matching placebo tablets', 'armGroupLabels': ['LX9211 Placebo']}, {'name': 'LX9211 (blinded)', 'type': 'DRUG', 'description': 'LX9211 (blinded) tablets', 'armGroupLabels': ['LX9211 High Dose', 'LX9211 High Dose Followed by Low Dose', 'LX9211 Low Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 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