Central Neuropathic PainPhase 2NCT02218203

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

A Phase 2 study testing Dextromethorphan and Lidocaine in people with Central Neuropathic Pain and Allodynia, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Central Neuropathic Pain, Allodynia, Spinal Cord Injury
What is being tested?: Dextromethorphan and Lidocaine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Apr 2003to Jan 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Translational Pain Research, Brigham and Women's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination (Factorial Design) Clinical Trial

Read the 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.

Conditions: Central Neuropathic Pain, Allodynia, Spinal Cord Injury
Being tested: Dextromethorphan, Lidocaine, Placebo (Dextromethorphan), Placebo (Lidocaine)
Keywords: chronic pain, central neuropathic pain, spinal cord injury, dextromethorphan, lidocaine, combination therapy, analgesia
Medical subject headings: Hyperalgesia, Spinal Cord Injuries, Chronic Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DextromethorphanDrug
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
LidocaineDrug
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

Study groups in NCT02218203
Study group	Role	What they receive
Placebo- 0mg/kg Lido	Placebo comparator	Placebo in combination with 0mg/kg LBM lidocaine Receives: Drug: Placebo (Dextromethorphan); Drug: Placebo (Lidocaine)
Placebo - 1mg/kg Lido	Experimental	Placebo in combination with 1mg/kg LBM lidocaine Receives: Drug: Lidocaine; Drug: Placebo (Dextromethorphan)
Placebo - 2mg/kg Lido	Experimental	Placebo in combination with 2mg/kg LBM lidocaine Receives: Drug: Lidocaine; Drug: Placebo (Dextromethorphan)
Placebo - 4mg/kg Lido	Experimental	Placebo in combination with 4mg/kg LBM lidocaine Receives: Drug: Lidocaine; Drug: Placebo (Dextromethorphan)
Low Dose Dex - 0mg/kg Lido	Experimental	Low dose dextromethorphan in combination with 0mg/kg LBM lidocaine Receives: Drug: Dextromethorphan; Drug: Placebo (Lidocaine)
Low Dose Dex - 1mg/kg Lido	Experimental	Low dose dextromethorphan in combination with 1mg/kg LBM lidocaine Receives: Drug: Dextromethorphan; Drug: Lidocaine
Low Dose Dex - 2mg/kg Lido	Experimental	Low dose dextromethorphan in combination with 2mg/kg LBM lidocaine Receives: Drug: Dextromethorphan; Drug: Lidocaine
Low Dose Dex - 4mg/kg Lido	Experimental	Low dose dextromethorphan in combination with 4mg/kg LBM lidocaine Receives: Drug: Dextromethorphan; Drug: Lidocaine
Medium Dose Dex - 0mg/kg Lido	Experimental	Medium dose dextromethorphan in combination with 0mg/kg LBM lidocaine Receives: Drug: Dextromethorphan; Drug: Placebo (Lidocaine)
Medium Dose Dex - 1mg/kg Lido	Experimental	Medium dose dextromethorphan in combination with 1mg/kg LBM lidocaine Receives: Drug: Dextromethorphan; Drug: Lidocaine
Medium Dose Dex - 2mg/kg Lido	Experimental	Medium dose dextromethorphan in combination with 2mg/kg LBM lidocaine Receives: Drug: Dextromethorphan; Drug: Lidocaine
Medium Dose Dex - 4mg/kg Lido	Experimental	Medium dose dextromethorphan in combination with 4mg/kg LBM lidocaine Receives: Drug: Dextromethorphan; Drug: Lidocaine
High Dose Dex - 0mg/kg Lido	Experimental	High dose dextromethorphan in combination with 0mg/kg LBM lidocaine Receives: Drug: Dextromethorphan; Drug: Placebo (Lidocaine)
High Dose Dex - 1mg/kg Lido	Experimental	High dose dextromethorphan in combination with 1mg/kg LBM lidocaine Receives: Drug: Dextromethorphan; Drug: Lidocaine
High Dose Dex - 2mg/kg Lido	Experimental	High dose dextromethorphan in combination with 2mg/kg LBM lidocaine Receives: Drug: Dextromethorphan; Drug: Lidocaine
High Dose Dex - 4mg/kg Lido	Experimental	High dose dextromethorphan in combination with 4mg/kg LBM lidocaine Receives: Drug: Dextromethorphan; Drug: Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 minutes post-infusion (Cmax)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2003Jan 2008

First posted18 Aug 2014 (estimated)
Study startApr 2003
Primary completionJan 2008
Study completionJan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Central Neuropathic PainStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02218203
Sponsor's protocol ID: 2000p001387
Other IDs: R01NS041503
Status last verified: Nov 2025
First submitted: 13 Aug 2014
Last updated: 8 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
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Effect of TMS on Neuropathic Pain for Patients With Spinal Cord Injury
Spinal Cord Injury, Neuropathic Pain
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Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm

All Central Neuropathic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination (Factorial Design) Clinical Trial
ClinicalTrials.gov ID: NCT02218203
Acronym / sponsor ID: 2000p001387
Conditions: Central Neuropathic Pain, Allodynia, Spinal Cord Injury
Keywords: chronic pain, central neuropathic pain, spinal cord injury, dextromethorphan, lidocaine, combination therapy, analgesia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Study start: Apr 2003
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 18 Aug 2014 (estimated)
Results: Posted 22 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 16

Arm	Type	Receives
Placebo- 0mg/kg Lido	Placebo comparator	Drug: Placebo (Dextromethorphan), Drug: Placebo (Lidocaine)Placebo in combination with 0mg/kg LBM lidocaine
Placebo - 1mg/kg Lido	Experimental	Drug: Lidocaine, Drug: Placebo (Dextromethorphan)Placebo in combination with 1mg/kg LBM lidocaine
Placebo - 2mg/kg Lido	Experimental	Drug: Lidocaine, Drug: Placebo (Dextromethorphan)Placebo in combination with 2mg/kg LBM lidocaine
Placebo - 4mg/kg Lido	Experimental	Drug: Lidocaine, Drug: Placebo (Dextromethorphan)Placebo in combination with 4mg/kg LBM lidocaine
Low Dose Dex - 0mg/kg Lido	Experimental	Drug: Dextromethorphan, Drug: Placebo (Lidocaine)Low dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Low Dose Dex - 1mg/kg Lido	Experimental	Drug: Dextromethorphan, Drug: LidocaineLow dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Low Dose Dex - 2mg/kg Lido	Experimental	Drug: Dextromethorphan, Drug: LidocaineLow dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Low Dose Dex - 4mg/kg Lido	Experimental	Drug: Dextromethorphan, Drug: LidocaineLow dose dextromethorphan in combination with 4mg/kg LBM lidocaine
Medium Dose Dex - 0mg/kg Lido	Experimental	Drug: Dextromethorphan, Drug: Placebo (Lidocaine)Medium dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Medium Dose Dex - 1mg/kg Lido	Experimental	Drug: Dextromethorphan, Drug: LidocaineMedium dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Medium Dose Dex - 2mg/kg Lido	Experimental	Drug: Dextromethorphan, Drug: LidocaineMedium dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Medium Dose Dex - 4mg/kg Lido	Experimental	Drug: Dextromethorphan, Drug: LidocaineMedium dose dextromethorphan in combination with 4mg/kg LBM lidocaine
High Dose Dex - 0mg/kg Lido	Experimental	Drug: Dextromethorphan, Drug: Placebo (Lidocaine)High dose dextromethorphan in combination with 0mg/kg LBM lidocaine
High Dose Dex - 1mg/kg Lido	Experimental	Drug: Dextromethorphan, Drug: LidocaineHigh dose dextromethorphan in combination with 1mg/kg LBM lidocaine
High Dose Dex - 2mg/kg Lido	Experimental	Drug: Dextromethorphan, Drug: LidocaineHigh dose dextromethorphan in combination with 2mg/kg LBM lidocaine
High Dose Dex - 4mg/kg Lido	Experimental	Drug: Dextromethorphan, Drug: LidocaineHigh dose dextromethorphan in combination with 4mg/kg LBM lidocaine

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DextromethorphanAdministered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)	Drug	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
Lidocaine0mg, 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	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
Placebo (Dextromethorphan)0mg Dextromethorphan	Drug	Placebo - 1mg/kg Lido, Placebo - 2mg/kg Lido, Placebo - 4mg/kg Lido, Placebo- 0mg/kg Lido
Placebo (Lidocaine)0mg/kg LBM Lidocaine	Drug	High Dose Dex - 0mg/kg Lido, Low Dose Dex - 0mg/kg Lido, Medium Dose Dex - 0mg/kg Lido, Placebo- 0mg/kg Lido

Primary outcome

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.

Results and safety

Results posted to the registry on 22 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dextromethorphan/Lidocaine Combination Clinical Trial	26	26

Primary outcome: Percent Change in Peak Pain Intensity

Time frame: 30 minutes post-infusion (Cmax). Mean (Standard Error). Unit: percentage change from baseline

Measure	Dextromethorphan/ 0mg/kg Lidocaine Combination n = 26	Dextromethorphan/1mg/kg Lidocaine Combination n = 26	Dextromethorphan/2mg/kg Lidocaine Combination n = 26	Dextromethorphan/4mg/kg Lidocaine Combination n = 26
Value	-2.5 (0.0049)	-7.9 (0.0176)	-11.2 (0.0015)	-19.2 (0.0226)

Dextromethorphan/ 0mg/kg Lidocaine Combination vs Dextromethorphan/1mg/kg Lidocaine Combination vs Dextromethorphan/2mg/kg Lidocaine Combination vs Dextromethorphan/4mg/kg Lidocaine Combination: Lidocaine dose*dextromethorphan dose: 0.0042 (95% CI 0.0004 to 0.0081), p = 0.0322, Pearson's Chi-squared test

Population analysed: 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.

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). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Dextromethorphan/0mg/kg Lidocaine Combination	0 of 0	4 of 24 (16.7%)	0 of 24
Placebo Dextromethorphan/1mg/kg Lidocaine Combination	0 of 24 (0%)	3 of 24 (12.5%)	0 of 24
Placebo Dextromethorphan/2mg/kg Lidocaine Combination	0 of 24 (0%)	5 of 24 (20.8%)	0 of 24
Placebo Dextromethorphan/4mg/kg Lidocaine Combination	0 of 24 (0%)	10 of 24 (41.7%)	0 of 24
Low Dose Dextromethorphan/0mg/kg Lidocaine Combination	0 of 26 (0%)	5 of 26 (19.2%)	0 of 26
Low Dose Dextromethorphan/1mg/kg Lidocaine Combination	0 of 26 (0%)	7 of 26 (26.9%)	0 of 26
Low Dose Dextromethorphan/2mg/kg Lidocaine Combination	0 of 26 (0%)	8 of 26 (30.8%)	0 of 26
Low Dose Dextromethorphan/4mg/kg Lidocaine Combination	0 of 26 (0%)	15 of 26 (57.7%)	0 of 26
Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination	0 of 24 (0%)	3 of 24 (12.5%)	0 of 24
Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination	0 of 24 (0%)	6 of 24 (25%)	0 of 24
Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination	0 of 24 (0%)	6 of 24 (25%)	0 of 24
Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination	0 of 24 (0%)	15 of 24 (62.5%)	0 of 24
High Dose Dextromethorphan/0mg/kg Lidocaine Combination	0 of 24 (0%)	3 of 24 (12.5%)	0 of 24
High Dose Dextromethorphan/1mg/kg Lidocaine Combination	0 of 24 (0%)	3 of 24 (12.5%)	0 of 24
High Dose Dextromethorphan/2mg/kg Lidocaine Combination	0 of 24 (0%)	6 of 24 (25%)	0 of 24
High Dose Dextromethorphan/4mg/kg Lidocaine Combination	0 of 24 (0%)	17 of 24 (70.8%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Translational Pain Research, Brigham and Women's HospitalLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christine N. Sang, MD, MPH principal investigator

Translational Pain Research, Brigham and Women's Hospital (Disclosure: Patent)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dextromethorphan and Lidocaine in people with Central Neuropathic Pain and Allodynia, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Peak Pain Intensity (time frame: 30 minutes post-infusion (Cmax)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02218203.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.