Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT02218203
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2014-08-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006930', 'term': 'Hyperalgesia'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003915', 'term': 'Dextromethorphan'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'paintrials@partners.org', 'phone': '617-525-7246', 'title': 'Christine N. Sang, MD, MPH', 'organization': "Translational Pain Research, Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Dextromethorphan/0mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 4, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Dextromethorphan/1mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 3, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Dextromethorphan/2mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 5, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo Dextromethorphan/4mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 10, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Low Dose Dextromethorphan/0mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 5, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Low Dose Dextromethorphan/1mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 7, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Low Dose Dextromethorphan/2mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 8, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Low Dose Dextromethorphan/4mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 15, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 3, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 6, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 6, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 15, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'High Dose Dextromethorphan/0mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 3, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'High Dose Dextromethorphan/1mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 3, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG014', 'title': 'High Dose Dextromethorphan/2mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 6, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG015', 'title': 'High Dose Dextromethorphan/4mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 17, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sedation Complex', 'notes': 'Dizziness, blurry vision, interference with ability to drive/alertness, etc.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 16, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 36, 'numAffected': 14}, {'groupId': 'EG008', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 24, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG010', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 24, 'numEvents': 28, 'numAffected': 14}, {'groupId': 'EG012', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 24, 'numEvents': 14, 'numAffected': 6}, {'groupId': 'EG015', 'numAtRisk': 24, 'numEvents': 38, 'numAffected': 16}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}, {'term': 'Euphoria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Parathesias', 'notes': 'Numbness, tingling, burning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG012', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cramping/Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Peak Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dextromethorphan/ 0mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 0mg/kg Lidocaine.'}, {'id': 'OG001', 'title': 'Dextromethorphan/1mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 1mg/kg Lidocaine.'}, {'id': 'OG002', 'title': 'Dextromethorphan/2mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 2mg/kg Lidocaine.'}, {'id': 'OG003', 'title': 'Dextromethorphan/4mg/kg Lidocaine Combination', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 4mg/kg Lidocaine.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.0049', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '0.0176', 'groupId': 'OG001'}, {'value': '-11.2', 'spread': '0.0015', 'groupId': 'OG002'}, {'value': '-19.2', 'spread': '0.0226', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0322', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Lidocaine dose*dextromethorphan dose', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0042', 'ciLowerLimit': '0.0004', 'ciUpperLimit': '0.0081', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0020', 'estimateComment': 'The estimated value is an estimated interaction term, and not a P-value.', 'groupDescription': 'We performed a lidocaine dose response clinical trial nested within a dextromethorphan clinical trial to evaluate a potential interaction between lidocaine dose and dextromethorphan dose (pain intensity; Gracely scale).', 'statisticalMethod': "Pearson's Chi-squared test", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'We report the interaction between the lidocaine dose response and dextromethorphan dose response. The type of statistical test was a linear regression model with Chi-square test.'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes post-infusion (Cmax)', 'description': 'Primary outcome was percent change from baseline in mean pain intensity at Cmax (transformed Gracely Scale; 0-35). Higher values on the Gracely scale represent greater pain intensity; the greater the percent change from baseline in mean pain intensity, the bigger the reduction in pain intensity.', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Central neuropathic pain following SCI; we present the primary efficacy endpoint (percent change in peak pain intensity) of this nested IV lidocaine dose-response clinical trial independent of the dextromethorphan doses, because the distribution of the dextromethorphan doses is balanced across the lidocaine treatment arms.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dextromethorphan/Lidocaine Combination Clinical Trial', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Placebo Dex v. 0mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Placebo Dex v. 1mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Placebo Dex v. 2mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Placebo Dex v. 4mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Low Dose Dex v. 0mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Low Dose Dex v. 1mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Low Dose Dex v. 2mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Low Dose Dex v. 4mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Medium Dose Dex v. 0mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Medium Dose Dex v. 1mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Medium Dose Dex v. 2mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Medium Dose Dex v. 4mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'High Dose Dex v. 0mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'High Dose Dex v. 1mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'High Dose Dex v. 2mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'High Dose Dex v. 4mg/km LBM Lidocaine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '2 subjects did not complete the placebo, medium dose, and high dose dex/lido combination arms.', 'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment began in March 2003. Subjects were recruited nationally from referring physicians, through advertisements, and through an existing database held by the PI.', 'preAssignmentDetails': 'During the screening visit, P450 2D6 phenotype status was determined for each subject to identify dextromethorphan-metabolizing capacity; those who were P450 2D6 poor-metabolizers were excluded. Following screen, subjects entered a dose escalation study to determine their maximum tolerated dose of dextromethorphan, prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dextromethorphan/Lidocaine Combination Clinical Trial', 'description': 'This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.84', 'spread': '11.32', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2014-08-13', 'resultsFirstSubmitDate': '2017-03-29', 'studyFirstSubmitQcDate': '2014-08-15', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2018-03-21', 'studyFirstPostDateStruct': {'date': '2014-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Peak Pain Intensity', 'timeFrame': '30 minutes post-infusion (Cmax)', 'description': 'Primary outcome was percent change from baseline in mean pain intensity at Cmax (transformed Gracely Scale; 0-35). Higher values on the Gracely scale represent greater pain intensity; the greater the percent change from baseline in mean pain intensity, the bigger the reduction in pain intensity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic pain', 'central neuropathic pain', 'spinal cord injury', 'dextromethorphan', 'lidocaine', 'combination therapy', 'analgesia'], 'conditions': ['Central Neuropathic Pain', 'Allodynia', 'Spinal Cord Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.paintrials.org', 'label': "Translational Pain Research, Brigham and Women's Hospital"}]}, 'descriptionModule': {'briefSummary': 'This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO) dextromethorphan and intravenous (IV) lidocaine in central neuropathic pain following spinal cord injury.', 'detailedDescription': 'This trial has several objectives:\n\nPrimary Objective To determine which combination (dose-ratio) of dextromethorphan and lidocaine provides the best balance of pain reduction and toxicity.\n\nSecondary Objectives include To evaluate the analgesic efficacy of both dextromethorphan and lidocaine in attenuating pain related to central nervous system sensitization, specifically spontaneous pain, mechanical allodynia, and hyperalgesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male or female adults, age 18 to 70 with central neuropathic pain for a minimum of 3 months following SCI as confirmed by neurologic evaluation, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication.\n2. Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions\n3. Serum laboratory examination obtained at study entry:\n4. Normal cognitive function.\n5. Signed informed consent.\n\nExclusion Criteria:\n\n1. Pregnancy or breast-feeding.\n2. Renal or hepatic dysfunction.\n3. Significant cardiac disease (e.g. MI within 1 year).\n4. Signs or symptoms of central neurological disorder, excluding SCI.\n5. Severe psychological disorder requiring treatment.\n6. History of hypersensitivity or intolerance to dextromethorphan or lidocaine.\n7. Participation in a study of an investigational drug or device within 30 days prior to screening for this study.'}, 'identificationModule': {'nctId': 'NCT02218203', 'briefTitle': 'Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination (Factorial Design) Clinical Trial', 'orgStudyIdInfo': {'id': '2000p001387'}, 'secondaryIdInfos': [{'id': 'R01NS041503', 'link': 'https://reporter.nih.gov/quickSearch/R01NS041503', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo- 0mg/kg Lido', 'description': 'Placebo in combination with 0mg/kg LBM lidocaine', 'interventionNames': ['Drug: Placebo (Dextromethorphan)', 'Drug: Placebo (Lidocaine)']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo - 1mg/kg Lido', 'description': 'Placebo in combination with 1mg/kg LBM lidocaine', 'interventionNames': ['Drug: Lidocaine', 'Drug: Placebo (Dextromethorphan)']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo - 2mg/kg Lido', 'description': 'Placebo in combination with 2mg/kg LBM lidocaine', 'interventionNames': ['Drug: Lidocaine', 'Drug: Placebo (Dextromethorphan)']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo - 4mg/kg Lido', 'description': 'Placebo in combination with 4mg/kg LBM lidocaine', 'interventionNames': ['Drug: Lidocaine', 'Drug: Placebo (Dextromethorphan)']}, {'type': 'EXPERIMENTAL', 'label': 'Low Dose Dex - 0mg/kg Lido', 'description': 'Low dose dextromethorphan in combination with 0mg/kg LBM lidocaine', 'interventionNames': ['Drug: Dextromethorphan', 'Drug: Placebo (Lidocaine)']}, {'type': 'EXPERIMENTAL', 'label': 'Low Dose Dex - 1mg/kg Lido', 'description': 'Low dose dextromethorphan in combination with 1mg/kg LBM lidocaine', 'interventionNames': ['Drug: Dextromethorphan', 'Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Low Dose Dex - 2mg/kg Lido', 'description': 'Low dose dextromethorphan in combination with 2mg/kg LBM lidocaine', 'interventionNames': ['Drug: Dextromethorphan', 'Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Low Dose Dex - 4mg/kg Lido', 'description': 'Low dose dextromethorphan in combination with 4mg/kg LBM lidocaine', 'interventionNames': ['Drug: Dextromethorphan', 'Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Medium Dose Dex - 0mg/kg Lido', 'description': 'Medium dose dextromethorphan in combination with 0mg/kg LBM lidocaine', 'interventionNames': ['Drug: Dextromethorphan', 'Drug: Placebo (Lidocaine)']}, {'type': 'EXPERIMENTAL', 'label': 'Medium Dose Dex - 1mg/kg Lido', 'description': 'Medium dose dextromethorphan in combination with 1mg/kg LBM lidocaine', 'interventionNames': ['Drug: Dextromethorphan', 'Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Medium Dose Dex - 2mg/kg Lido', 'description': 'Medium dose dextromethorphan in combination with 2mg/kg LBM lidocaine', 'interventionNames': ['Drug: Dextromethorphan', 'Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Medium Dose Dex - 4mg/kg Lido', 'description': 'Medium dose dextromethorphan in combination with 4mg/kg LBM lidocaine', 'interventionNames': ['Drug: Dextromethorphan', 'Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose Dex - 0mg/kg Lido', 'description': 'High dose dextromethorphan in combination with 0mg/kg LBM lidocaine', 'interventionNames': ['Drug: Dextromethorphan', 'Drug: Placebo (Lidocaine)']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose Dex - 1mg/kg Lido', 'description': 'High dose dextromethorphan in combination with 1mg/kg LBM lidocaine', 'interventionNames': ['Drug: Dextromethorphan', 'Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose Dex - 2mg/kg Lido', 'description': 'High dose dextromethorphan in combination with 2mg/kg LBM lidocaine', 'interventionNames': ['Drug: Dextromethorphan', 'Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose Dex - 4mg/kg Lido', 'description': 'High dose dextromethorphan in combination with 4mg/kg LBM lidocaine', 'interventionNames': ['Drug: Dextromethorphan', 'Drug: Lidocaine']}], 'interventions': [{'name': 'Dextromethorphan', 'type': 'DRUG', 'description': "Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)", 'armGroupLabels': ['High Dose Dex - 0mg/kg Lido', 'High Dose Dex - 1mg/kg Lido', 'High Dose Dex - 2mg/kg Lido', 'High Dose Dex - 4mg/kg Lido', 'Low Dose Dex - 0mg/kg Lido', 'Low Dose Dex - 1mg/kg Lido', 'Low Dose Dex - 2mg/kg Lido', 'Low Dose Dex - 4mg/kg Lido', 'Medium Dose Dex - 0mg/kg Lido', 'Medium Dose Dex - 1mg/kg Lido', 'Medium Dose Dex - 2mg/kg Lido', 'Medium Dose Dex - 4mg/kg Lido']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': '0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)', 'armGroupLabels': ['High Dose Dex - 1mg/kg Lido', 'High Dose Dex - 2mg/kg Lido', 'High Dose Dex - 4mg/kg Lido', 'Low Dose Dex - 1mg/kg Lido', 'Low Dose Dex - 2mg/kg Lido', 'Low Dose Dex - 4mg/kg Lido', 'Medium Dose Dex - 1mg/kg Lido', 'Medium Dose Dex - 2mg/kg Lido', 'Medium Dose Dex - 4mg/kg Lido', 'Placebo - 1mg/kg Lido', 'Placebo - 2mg/kg Lido', 'Placebo - 4mg/kg Lido']}, {'name': 'Placebo (Dextromethorphan)', 'type': 'DRUG', 'description': '0mg Dextromethorphan', 'armGroupLabels': ['Placebo - 1mg/kg Lido', 'Placebo - 2mg/kg Lido', 'Placebo - 4mg/kg Lido', 'Placebo- 0mg/kg Lido']}, {'name': 'Placebo (Lidocaine)', 'type': 'DRUG', 'description': '0mg/kg LBM Lidocaine', 'armGroupLabels': ['High Dose Dex - 0mg/kg Lido', 'Low Dose Dex - 0mg/kg Lido', 'Medium Dose Dex - 0mg/kg Lido', 'Placebo- 0mg/kg Lido']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Translational Pain Research, Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Christine N. Sang, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Translational Pain Research, Brigham and Women's Hospital (Disclosure: Patent)"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Translational Pain Research', 'investigatorFullName': 'Christine N. Sang, MD, MPH', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}