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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS041503 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
This trial has several objectives:
Primary Objective To determine which combination (dose-ratio) of dextromethorphan and lidocaine provides the best balance of pain reduction and toxicity.
Secondary 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo- 0mg/kg Lido | Placebo Comparator | Placebo in combination with 0mg/kg LBM lidocaine |
|
| Placebo - 1mg/kg Lido | Experimental | Placebo in combination with 1mg/kg LBM lidocaine |
|
| Placebo - 2mg/kg Lido | Experimental | Placebo in combination with 2mg/kg LBM lidocaine |
|
| Placebo - 4mg/kg Lido | Experimental | Placebo in combination with 4mg/kg LBM lidocaine |
|
| Low Dose Dex - 0mg/kg Lido | Experimental | Low dose dextromethorphan in combination with 0mg/kg LBM lidocaine |
|
| Low Dose Dex - 1mg/kg Lido |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextromethorphan | Drug | Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Peak Pain Intensity | 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. | 30 minutes post-infusion (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine N. Sang, MD, MPH | Translational Pain Research, Brigham and Women's Hospital (Disclosure: Patent) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Translational Pain Research, Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| Label | URL |
|---|---|
| Translational Pain Research, Brigham and Women's Hospital | View source |
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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.
Recruitment began in March 2003. Subjects were recruited nationally from referring physicians, through advertisements, and through an existing database held by the PI.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dextromethorphan/Lidocaine Combination Clinical Trial | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Low dose dextromethorphan in combination with 1mg/kg LBM lidocaine |
|
| Low Dose Dex - 2mg/kg Lido | Experimental | Low dose dextromethorphan in combination with 2mg/kg LBM lidocaine |
|
| Low Dose Dex - 4mg/kg Lido | Experimental | Low dose dextromethorphan in combination with 4mg/kg LBM lidocaine |
|
| Medium Dose Dex - 0mg/kg Lido | Experimental | Medium dose dextromethorphan in combination with 0mg/kg LBM lidocaine |
|
| Medium Dose Dex - 1mg/kg Lido | Experimental | Medium dose dextromethorphan in combination with 1mg/kg LBM lidocaine |
|
| Medium Dose Dex - 2mg/kg Lido | Experimental | Medium dose dextromethorphan in combination with 2mg/kg LBM lidocaine |
|
| Medium Dose Dex - 4mg/kg Lido | Experimental | Medium dose dextromethorphan in combination with 4mg/kg LBM lidocaine |
|
| High Dose Dex - 0mg/kg Lido | Experimental | High dose dextromethorphan in combination with 0mg/kg LBM lidocaine |
|
| High Dose Dex - 1mg/kg Lido | Experimental | High dose dextromethorphan in combination with 1mg/kg LBM lidocaine |
|
| High Dose Dex - 2mg/kg Lido | Experimental | High dose dextromethorphan in combination with 2mg/kg LBM lidocaine |
|
| High Dose Dex - 4mg/kg Lido | Experimental | High dose dextromethorphan in combination with 4mg/kg LBM lidocaine |
|
| Lidocaine | Drug | 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) |
|
| Placebo (Dextromethorphan) | Drug | 0mg Dextromethorphan |
|
| Placebo (Lidocaine) | Drug | 0mg/kg LBM Lidocaine |
|
| Placebo Dex v. 0mg/km LBM Lidocaine |
|
| Placebo Dex v. 1mg/km LBM Lidocaine |
|
| Placebo Dex v. 2mg/km LBM Lidocaine |
|
| Placebo Dex v. 4mg/km LBM Lidocaine |
|
| Low Dose Dex v. 0mg/km LBM Lidocaine |
|
| Low Dose Dex v. 1mg/km LBM Lidocaine |
|
| Low Dose Dex v. 2mg/km LBM Lidocaine |
|
| Low Dose Dex v. 4mg/km LBM Lidocaine |
|
| Medium Dose Dex v. 0mg/km LBM Lidocaine |
|
| Medium Dose Dex v. 1mg/km LBM Lidocaine |
|
| Medium Dose Dex v. 2mg/km LBM Lidocaine |
|
| Medium Dose Dex v. 4mg/km LBM Lidocaine |
|
| High Dose Dex v. 0mg/km LBM Lidocaine |
|
| High Dose Dex v. 1mg/km LBM Lidocaine |
|
| High Dose Dex v. 2mg/km LBM Lidocaine |
|
| High Dose Dex v. 4mg/km LBM Lidocaine |
|
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dextromethorphan/Lidocaine Combination Clinical Trial | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Peak Pain Intensity | 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. | 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. | Posted | Mean | Standard Error | percentage change from baseline | 30 minutes post-infusion (Cmax) |
|
|
|
|
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)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Dextromethorphan/0mg/kg Lidocaine Combination | 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. | 0 | 24 | 0 | 0 | 4 | 24 |
| EG001 | Placebo Dextromethorphan/1mg/kg Lidocaine Combination | 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. | 0 | 24 | 0 | 24 | 3 | 24 |
| EG002 | Placebo Dextromethorphan/2mg/kg Lidocaine Combination | 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. | 0 | 24 | 0 | 24 | 5 | 24 |
| EG003 | Placebo Dextromethorphan/4mg/kg Lidocaine Combination | 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. | 0 | 24 | 0 | 24 | 10 | 24 |
| EG004 | Low Dose Dextromethorphan/0mg/kg Lidocaine Combination | 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. | 0 | 26 | 0 | 26 | 5 | 26 |
| EG005 | Low Dose Dextromethorphan/1mg/kg Lidocaine Combination | 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. | 0 | 26 | 0 | 26 | 7 | 26 |
| EG006 | Low Dose Dextromethorphan/2mg/kg Lidocaine Combination | 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. | 0 | 26 | 0 | 26 | 8 | 26 |
| EG007 | Low Dose Dextromethorphan/4mg/kg Lidocaine Combination | 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. | 0 | 26 | 0 | 26 | 15 | 26 |
| EG008 | Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination | 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. | 0 | 24 | 0 | 24 | 3 | 24 |
| EG009 | Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination | 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. | 0 | 24 | 0 | 24 | 6 | 24 |
| EG010 | Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination | 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. | 0 | 24 | 0 | 24 | 6 | 24 |
| EG011 | Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination | 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. | 0 | 24 | 0 | 24 | 15 | 24 |
| EG012 | High Dose Dextromethorphan/0mg/kg Lidocaine Combination | 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. | 0 | 24 | 0 | 24 | 3 | 24 |
| EG013 | High Dose Dextromethorphan/1mg/kg Lidocaine Combination | 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. | 0 | 24 | 0 | 24 | 3 | 24 |
| EG014 | High Dose Dextromethorphan/2mg/kg Lidocaine Combination | 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. | 0 | 24 | 0 | 24 | 6 | 24 |
| EG015 | High Dose Dextromethorphan/4mg/kg Lidocaine Combination | 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. | 0 | 24 | 0 | 24 | 17 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation Complex | Nervous system disorders | Dizziness, blurry vision, interference with ability to drive/alertness, etc. |
| ||
| Dry mouth | Nervous system disorders |
| |||
| Euphoria | Nervous system disorders |
| |||
| Parathesias | Nervous system disorders | Numbness, tingling, burning |
| ||
| Cramping/Spasms | Musculoskeletal and connective tissue disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine N. Sang, MD, MPH | Translational Pain Research, Brigham and Women's Hospital | 617-525-7246 | paintrials@partners.org |
| ID | Term |
|---|---|
| D006930 | Hyperalgesia |
| D013119 | Spinal Cord Injuries |
| D059350 | Chronic Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D003915 | Dextromethorphan |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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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.