Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02218203
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
• Enrollment: 26
• Location: 1
• Arms: 16
• Duration (Months): 57
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Central Neuropathic Pain; Allodynia; Spinal Cord Injury	Drug: Dextromethorphan; Drug: Lidocaine; Drug: Placebo (Dextromethorphan); Drug: Placebo (Lidocaine)	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination (Factorial Design) Clinical Trial
• Study Start Date: Apr 1, 2003
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo- 0mg/kg Lido Placebo in combination with 0mg/kg LBM lidocaine	Drug: Placebo (Dextromethorphan); 0mg Dextromethorphan; Drug: Placebo (Lidocaine); 0mg/kg LBM Lidocaine
Experimental: Placebo - 1mg/kg Lido Placebo in combination with 1mg/kg LBM lidocaine	Drug: Lidocaine; 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); Drug: Placebo (Dextromethorphan); 0mg Dextromethorphan
Experimental: Placebo - 2mg/kg Lido Placebo in combination with 2mg/kg LBM lidocaine	Drug: Lidocaine; 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); Drug: Placebo (Dextromethorphan); 0mg Dextromethorphan
Experimental: Placebo - 4mg/kg Lido Placebo in combination with 4mg/kg LBM lidocaine	Drug: Lidocaine; 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); Drug: Placebo (Dextromethorphan); 0mg Dextromethorphan
Experimental: Low Dose Dex - 0mg/kg Lido Low dose dextromethorphan in combination with 0mg/kg LBM lidocaine	Drug: Dextromethorphan; Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD); Drug: Placebo (Lidocaine); 0mg/kg LBM Lidocaine
Experimental: Low Dose Dex - 1mg/kg Lido Low dose dextromethorphan in combination with 1mg/kg LBM lidocaine	Drug: Dextromethorphan; Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD); Drug: Lidocaine; 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)
Experimental: Low Dose Dex - 2mg/kg Lido Low dose dextromethorphan in combination with 2mg/kg LBM lidocaine	Drug: Dextromethorphan; Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD); Drug: Lidocaine; 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)
Experimental: Low Dose Dex - 4mg/kg Lido Low dose dextromethorphan in combination with 4mg/kg LBM lidocaine	Drug: Dextromethorphan; Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD); Drug: Lidocaine; 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)
Experimental: Medium Dose Dex - 0mg/kg Lido Medium dose dextromethorphan in combination with 0mg/kg LBM lidocaine	Drug: Dextromethorphan; Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD); Drug: Placebo (Lidocaine); 0mg/kg LBM Lidocaine
Experimental: Medium Dose Dex - 1mg/kg Lido Medium dose dextromethorphan in combination with 1mg/kg LBM lidocaine	Drug: Dextromethorphan; Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD); Drug: Lidocaine; 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)
Experimental: Medium Dose Dex - 2mg/kg Lido Medium dose dextromethorphan in combination with 2mg/kg LBM lidocaine	Drug: Dextromethorphan; Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD); Drug: Lidocaine; 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)
Experimental: Medium Dose Dex - 4mg/kg Lido Medium dose dextromethorphan in combination with 4mg/kg LBM lidocaine	Drug: Dextromethorphan; Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD); Drug: Lidocaine; 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)
Experimental: High Dose Dex - 0mg/kg Lido High dose dextromethorphan in combination with 0mg/kg LBM lidocaine	Drug: Dextromethorphan; Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD); Drug: Placebo (Lidocaine); 0mg/kg LBM Lidocaine
Experimental: High Dose Dex - 1mg/kg Lido High dose dextromethorphan in combination with 1mg/kg LBM lidocaine	Drug: Dextromethorphan; Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD); Drug: Lidocaine; 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)
Experimental: High Dose Dex - 2mg/kg Lido High dose dextromethorphan in combination with 2mg/kg LBM lidocaine	Drug: Dextromethorphan; Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD); Drug: Lidocaine; 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)
Experimental: High Dose Dex - 4mg/kg Lido High dose dextromethorphan in combination with 4mg/kg LBM lidocaine	Drug: Dextromethorphan; Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD); Drug: Lidocaine; 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)

Outcome Measures

Primary Outcome Measures

1. Percent Change in Peak Pain Intensity [30 minutes post-infusion (Cmax)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 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.

2. Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions

3. Serum laboratory examination obtained at study entry:

4. Normal cognitive function.

5. Signed informed consent.

Exclusion Criteria:

1. Pregnancy or breast-feeding.

2. Renal or hepatic dysfunction.

3. Significant cardiac disease (e.g. MI within 1 year).

4. Signs or symptoms of central neurological disorder, excluding SCI.

5. Severe psychological disorder requiring treatment.

6. History of hypersensitivity or intolerance to dextromethorphan or lidocaine.

7. Participation in a study of an investigational drug or device within 30 days prior to screening for this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Translational Pain Research, Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital
• National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

• Principal Investigator: Christine N. Sang, MD, MPH, Translational Pain Research, Brigham and Women's Hospital (Disclosure: Patent)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Translational Pain Research, Brigham and Women's Hospital

Publications

None provided.

• Responsible Party: Christine N. Sang, MD, MPH, Director, Translational Pain Research, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02218203
• Other Study ID Numbers: RO1NS41503-2
• First Posted: Aug 18, 2014
• Last Update Posted: Mar 22, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Christine N. Sang, MD, MPH, Director, Translational Pain Research, Brigham and Women's Hospital: chronic pain; central neuropathic pain; spinal cord injury; dextromethorphan; lidocaine; combination therapy; analgesia
• Additional relevant MeSH terms: Spinal Cord Injuries; Neuralgia; Hyperalgesia; Wounds and Injuries; Lidocaine; Dextromethorphan

Study Results

Participant Flow

Recruitment Details	Recruitment began in March 2003. Subjects were recruited nationally from referring physicians, through advertisements, and through an existing database held by the PI.
Pre-assignment Detail	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.

Arm/Group Title	Dextromethorphan/Lidocaine Combination Clinical Trial
Arm/Group 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.
Period Title: Overall Study
STARTED	26
Placebo Dex v. 0mg/km LBM Lidocaine	24
Placebo Dex v. 1mg/km LBM Lidocaine	24
Placebo Dex v. 2mg/km LBM Lidocaine	24
Placebo Dex v. 4mg/km LBM Lidocaine	24
Low Dose Dex v. 0mg/km LBM Lidocaine	26
Low Dose Dex v. 1mg/km LBM Lidocaine	26
Low Dose Dex v. 2mg/km LBM Lidocaine	26
Low Dose Dex v. 4mg/km LBM Lidocaine	26
Medium Dose Dex v. 0mg/km LBM Lidocaine	24
Medium Dose Dex v. 1mg/km LBM Lidocaine	24
Medium Dose Dex v. 2mg/km LBM Lidocaine	24
Medium Dose Dex v. 4mg/km LBM Lidocaine	24
High Dose Dex v. 0mg/km LBM Lidocaine	24
High Dose Dex v. 1mg/km LBM Lidocaine	24
High Dose Dex v. 2mg/km LBM Lidocaine	24
High Dose Dex v. 4mg/km LBM Lidocaine	24
COMPLETED	26
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Dextromethorphan/Lidocaine Combination Clinical Trial
Arm/Group 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.
Overall Participants	26
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	25 96.2%
>=65 years	1 3.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.84 (11.32)
Sex: Female, Male (Count of Participants)
Female	14 53.8%
Male	12 46.2%
Region of Enrollment (participants) [Number]
North America	26 100%

Outcome Measures

1. Primary Outcome

Title	Percent Change in Peak Pain Intensity
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.
Time Frame	30 minutes post-infusion (Cmax)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dextromethorphan/ 0mg/kg Lidocaine Combination	Dextromethorphan/1mg/kg Lidocaine Combination	Dextromethorphan/2mg/kg Lidocaine Combination	Dextromethorphan/4mg/kg Lidocaine Combination
Arm/Group 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.	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.	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.	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.
Measure Participants	26	26	26	26
Mean (Standard Error) [percentage change from baseline]	-2.5 (0.0049)	-7.9 (0.0176)	-11.2 (0.0015)	-19.2 (0.0226)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dextromethorphan/ 0mg/kg Lidocaine Combination, Dextromethorphan/1mg/kg Lidocaine Combination, Dextromethorphan/2mg/kg Lidocaine Combination, Dextromethorphan/4mg/kg Lidocaine Combination
	Comments	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).
	Type of Statistical Test	Other
	Comments	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.
Statistical Test of Hypothesis	p-Value	0.0322
	Comments
	Method	Pearson's Chi-squared test
	Comments
Method of Estimation	Estimation Parameter	Lidocaine dose*dextromethorphan dose
	Estimated Value	0.0042
	Confidence Interval	(2-Sided) 95%; 0.0004 to 0.0081
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0020
	Estimation Comments	The estimated value is an estimated interaction term, and not a P-value.

Adverse Events

Time Frame	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)
Arm/Group Title	Placebo Dextromethorphan/0mg/kg Lidocaine Combination		Placebo Dextromethorphan/1mg/kg Lidocaine Combination		Placebo Dextromethorphan/2mg/kg Lidocaine Combination		Placebo Dextromethorphan/4mg/kg Lidocaine Combination		Low Dose Dextromethorphan/0mg/kg Lidocaine Combination		Low Dose Dextromethorphan/1mg/kg Lidocaine Combination		Low Dose Dextromethorphan/2mg/kg Lidocaine Combination		Low Dose Dextromethorphan/4mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination		High Dose Dextromethorphan/0mg/kg Lidocaine Combination		High Dose Dextromethorphan/1mg/kg Lidocaine Combination		High Dose Dextromethorphan/2mg/kg Lidocaine Combination		High Dose Dextromethorphan/4mg/kg Lidocaine Combination
Arm/Group 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.
All Cause Mortality
	Placebo Dextromethorphan/0mg/kg Lidocaine Combination		Placebo Dextromethorphan/1mg/kg Lidocaine Combination		Placebo Dextromethorphan/2mg/kg Lidocaine Combination		Placebo Dextromethorphan/4mg/kg Lidocaine Combination		Low Dose Dextromethorphan/0mg/kg Lidocaine Combination		Low Dose Dextromethorphan/1mg/kg Lidocaine Combination		Low Dose Dextromethorphan/2mg/kg Lidocaine Combination		Low Dose Dextromethorphan/4mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination		High Dose Dextromethorphan/0mg/kg Lidocaine Combination		High Dose Dextromethorphan/1mg/kg Lidocaine Combination		High Dose Dextromethorphan/2mg/kg Lidocaine Combination		High Dose Dextromethorphan/4mg/kg Lidocaine Combination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/26 (0%)		0/26 (0%)		0/26 (0%)		0/26 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)
Serious Adverse Events
	Placebo Dextromethorphan/0mg/kg Lidocaine Combination		Placebo Dextromethorphan/1mg/kg Lidocaine Combination		Placebo Dextromethorphan/2mg/kg Lidocaine Combination		Placebo Dextromethorphan/4mg/kg Lidocaine Combination		Low Dose Dextromethorphan/0mg/kg Lidocaine Combination		Low Dose Dextromethorphan/1mg/kg Lidocaine Combination		Low Dose Dextromethorphan/2mg/kg Lidocaine Combination		Low Dose Dextromethorphan/4mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination		High Dose Dextromethorphan/0mg/kg Lidocaine Combination		High Dose Dextromethorphan/1mg/kg Lidocaine Combination		High Dose Dextromethorphan/2mg/kg Lidocaine Combination		High Dose Dextromethorphan/4mg/kg Lidocaine Combination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/26 (0%)		0/26 (0%)		0/26 (0%)		0/26 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Placebo Dextromethorphan/0mg/kg Lidocaine Combination		Placebo Dextromethorphan/1mg/kg Lidocaine Combination		Placebo Dextromethorphan/2mg/kg Lidocaine Combination		Placebo Dextromethorphan/4mg/kg Lidocaine Combination		Low Dose Dextromethorphan/0mg/kg Lidocaine Combination		Low Dose Dextromethorphan/1mg/kg Lidocaine Combination		Low Dose Dextromethorphan/2mg/kg Lidocaine Combination		Low Dose Dextromethorphan/4mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination		Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination		High Dose Dextromethorphan/0mg/kg Lidocaine Combination		High Dose Dextromethorphan/1mg/kg Lidocaine Combination		High Dose Dextromethorphan/2mg/kg Lidocaine Combination		High Dose Dextromethorphan/4mg/kg Lidocaine Combination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/24 (16.7%)		3/24 (12.5%)		5/24 (20.8%)		10/24 (41.7%)		5/26 (19.2%)		7/26 (26.9%)		8/26 (30.8%)		15/26 (57.7%)		3/24 (12.5%)		6/24 (25%)		6/24 (25%)		15/24 (62.5%)		3/24 (12.5%)		3/24 (12.5%)		6/24 (25%)		17/24 (70.8%)
Musculoskeletal and connective tissue disorders
Cramping/Spasms	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/26 (0%)	0	0/26 (0%)	0	0/26 (0%)	0	0/26 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	3	2/24 (8.3%)	2	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Nervous system disorders
Sedation Complex	3/24 (12.5%)	5	3/24 (12.5%)	7	5/24 (20.8%)	7	7/24 (29.2%)	15	5/26 (19.2%)	7	7/26 (26.9%)	10	7/26 (26.9%)	16	14/26 (53.8%)	36	3/24 (12.5%)	6	5/24 (20.8%)	12	4/24 (16.7%)	8	14/24 (58.3%)	28	3/24 (12.5%)	6	2/24 (8.3%)	2	6/24 (25%)	14	16/24 (66.7%)	38
Dry mouth	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	2/26 (7.7%)	2	2/26 (7.7%)	2	2/26 (7.7%)	2	5/26 (19.2%)	5	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	3/24 (12.5%)	3	2/24 (8.3%)	2	0/24 (0%)	0	2/24 (8.3%)	2	4/24 (16.7%)	4
Euphoria	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	0/26 (0%)	0	0/26 (0%)	0	0/26 (0%)	0	2/26 (7.7%)	2	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	1/24 (4.2%)	1	1/24 (4.2%)	1	2/24 (8.3%)	2
Parathesias	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	4/24 (16.7%)	5	0/26 (0%)	0	2/26 (7.7%)	3	3/26 (11.5%)	4	5/26 (19.2%)	8	0/24 (0%)	0	2/24 (8.3%)	2	0/24 (0%)	0	7/24 (29.2%)	8	0/24 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	3	7/24 (29.2%)	10

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.