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

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ClinicalTrials.gov Identifier: NCT02218203
Recruitment Status : Completed
First Posted : August 18, 2014
Results First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Christine N. Sang, MD, MPH, Brigham and Women's Hospital

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.


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Study Type : Interventional  (Clinical Trial)
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 : April 2003
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Percent Change in Peak Pain Intensity [ Time Frame: 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.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218203


Locations
Layout table for location information
United States, Massachusetts
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
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Principal Investigator: Christine N. Sang, MD, MPH Translational Pain Research, Brigham and Women's Hospital (Disclosure: Patent)

Additional Information:
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Responsible Party: Christine N. Sang, MD, MPH, Director, Translational Pain Research, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02218203     History of Changes
Other Study ID Numbers: RO1NS41503-2
First Posted: August 18, 2014    Key Record Dates
Results First Posted: March 22, 2018
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, Brigham and Women's Hospital:
chronic pain
central neuropathic pain
spinal cord injury
dextromethorphan
lidocaine
combination therapy
analgesia
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Spinal Cord Injuries
Neuralgia
Hyperalgesia
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Peripheral Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Somatosensory Disorders
Sensation Disorders
Dextromethorphan
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antitussive Agents
Respiratory System Agents