Back to resultsClinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial
Primary Purpose
Central Neuropathic Pain, Allodynia, Spinal Cord Injury
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dextromethorphan
Lidocaine
Placebo (Dextromethorphan)
Placebo (Lidocaine)
Sponsored by
About this trial
This is an interventional treatment trial for Central Neuropathic Pain focused on measuring chronic pain, central neuropathic pain, spinal cord injury, dextromethorphan, lidocaine, combination therapy, analgesia
Eligibility Criteria
Inclusion Criteria:
- 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.
- Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions
- Serum laboratory examination obtained at study entry:
- Normal cognitive function.
- Signed informed consent.
Exclusion Criteria:
- Pregnancy or breast-feeding.
- Renal or hepatic dysfunction.
- Significant cardiac disease (e.g. MI within 1 year).
- Signs or symptoms of central neurological disorder, excluding SCI.
- Severe psychological disorder requiring treatment.
- History of hypersensitivity or intolerance to dextromethorphan or lidocaine.
- Participation in a study of an investigational drug or device within 30 days prior to screening for this study.
Sites / Locations
- Translational Pain Research, Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo- 0mg/kg Lido
Placebo - 1mg/kg Lido
Placebo - 2mg/kg Lido
Placebo - 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
High Dose Dex - 0mg/kg Lido
High Dose Dex - 1mg/kg Lido
High Dose Dex - 2mg/kg Lido
High Dose Dex - 4mg/kg Lido
Arm Description
Placebo in combination with 0mg/kg LBM lidocaine
Placebo in combination with 1mg/kg LBM lidocaine
Placebo in combination with 2mg/kg LBM lidocaine
Placebo in combination with 4mg/kg LBM lidocaine
Low dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Low dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Low dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Low dose dextromethorphan in combination with 4mg/kg LBM lidocaine
Medium dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Medium dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Medium dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Medium dose dextromethorphan in combination with 4mg/kg LBM lidocaine
High dose dextromethorphan in combination with 0mg/kg LBM lidocaine
High dose dextromethorphan in combination with 1mg/kg LBM lidocaine
High dose dextromethorphan in combination with 2mg/kg LBM lidocaine
High dose dextromethorphan in combination with 4mg/kg LBM lidocaine
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02218203
First Posted
August 13, 2014
Last Updated
March 21, 2018
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT02218203
Brief Title
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial
Official Title
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination (Factorial Design) Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Neuropathic Pain, Allodynia, Spinal Cord Injury
Keywords
chronic pain, central neuropathic pain, spinal cord injury, dextromethorphan, lidocaine, combination therapy, analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo- 0mg/kg Lido
Arm Type
Placebo Comparator
Arm Description
Placebo in combination with 0mg/kg LBM lidocaine
Arm Title
Placebo - 1mg/kg Lido
Arm Type
Experimental
Arm Description
Placebo in combination with 1mg/kg LBM lidocaine
Arm Title
Placebo - 2mg/kg Lido
Arm Type
Experimental
Arm Description
Placebo in combination with 2mg/kg LBM lidocaine
Arm Title
Placebo - 4mg/kg Lido
Arm Type
Experimental
Arm Description
Placebo in combination with 4mg/kg LBM lidocaine
Arm Title
Low Dose Dex - 0mg/kg Lido
Arm Type
Experimental
Arm Description
Low dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Arm Title
Low Dose Dex - 1mg/kg Lido
Arm Type
Experimental
Arm Description
Low dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Arm Title
Low Dose Dex - 2mg/kg Lido
Arm Type
Experimental
Arm Description
Low dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Arm Title
Low Dose Dex - 4mg/kg Lido
Arm Type
Experimental
Arm Description
Low dose dextromethorphan in combination with 4mg/kg LBM lidocaine
Arm Title
Medium Dose Dex - 0mg/kg Lido
Arm Type
Experimental
Arm Description
Medium dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Arm Title
Medium Dose Dex - 1mg/kg Lido
Arm Type
Experimental
Arm Description
Medium dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Arm Title
Medium Dose Dex - 2mg/kg Lido
Arm Type
Experimental
Arm Description
Medium dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Arm Title
Medium Dose Dex - 4mg/kg Lido
Arm Type
Experimental
Arm Description
Medium dose dextromethorphan in combination with 4mg/kg LBM lidocaine
Arm Title
High Dose Dex - 0mg/kg Lido
Arm Type
Experimental
Arm Description
High dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Arm Title
High Dose Dex - 1mg/kg Lido
Arm Type
Experimental
Arm Description
High dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Arm Title
High Dose Dex - 2mg/kg Lido
Arm Type
Experimental
Arm Description
High dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Arm Title
High Dose Dex - 4mg/kg Lido
Arm Type
Experimental
Arm Description
High dose dextromethorphan in combination with 4mg/kg LBM lidocaine
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Intervention Description
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention 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)
Intervention Type
Drug
Intervention Name(s)
Placebo (Dextromethorphan)
Intervention Description
0mg Dextromethorphan
Intervention Type
Drug
Intervention Name(s)
Placebo (Lidocaine)
Intervention Description
0mg/kg LBM Lidocaine
Primary Outcome Measure Information:
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions
Serum laboratory examination obtained at study entry:
Normal cognitive function.
Signed informed consent.
Exclusion Criteria:
Pregnancy or breast-feeding.
Renal or hepatic dysfunction.
Significant cardiac disease (e.g. MI within 1 year).
Signs or symptoms of central neurological disorder, excluding SCI.
Severe psychological disorder requiring treatment.
History of hypersensitivity or intolerance to dextromethorphan or lidocaine.
Participation in a study of an investigational drug or device within 30 days prior to screening for this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine N. Sang, MD, MPH
Organizational Affiliation
Translational Pain Research, Brigham and Women's Hospital (Disclosure: Patent)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Translational Pain Research, Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://www.paintrials.org
Description
Translational Pain Research, Brigham and Women's Hospital
Learn more about this trial
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial
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