Central Neuropathic PainPhase 2NCT01435798
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical Trial
A Phase 2 study testing Dextromethorphan in people with Central Neuropathic Pain and Allodynia, run by Brigham and Women's Hospital at 1 site in United States.
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 three doses of chronic oral (PO) dextromethorphan compared to placebo 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
- 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:
- Liver function tests (albumin within 20% of normal, SGOT/SGPT within 50% of normal).
- For women of childbearing age: negative serum beta HCG.
- Postmenopausal women, or be physically incapable of childbearing, or be practicing an acceptable method of birth control.
Show all 10Show fewer
- Normal cognitive function.
- Normal communicative ability (English).
- Ability to demonstrate competence in recording five times daily in pain diary for 1 week (with 100% compliance), and in completing required questionnaires.
- 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.
- Concurrent use of monoamine oxidase inhibitors within 2 weeks prior to study entry.
Show all 11Show fewer
- Use of known CYP2D6 (but not CYP3A4) inhibitors or inducers.
- History of hypersensitivity or intolerance to dextromethorphan or lidocaine.
- Chronic substance abuse, including alcohol.
- Participation in a study of an investigational drug or device within 30 days prior to screening for this study.
- Poor metabolizer of P450 2D6 substrates.
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational Pain Research, Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of three doses of chronic oral (PO) dextromethorphan compared to placebo in central neuropathic pain following spinal cord injury. Subjects' maximally tolerated doses (MTD) were first determined to establish individual dose-analgesic response relationships in a run-in period; following a washout period, subjects were then randomized to receive an order of four doses of dextromethorphan (including placebo) in a 4x4 Latin square cross-over design.
- Conditions
- Central Neuropathic Pain, Allodynia, Spinal Cord Injury
- Being tested
- Dextromethorphan
- 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
0, 25, 50 and 100% of maximum tolerated dose, each administered over a 4 week period
| Study group | Role | What they receive |
|---|---|---|
| 0% MTD Dex | Placebo comparator | 0% MTD Dextromethorphan Receives: Drug: Dextromethorphan |
| 25% MTD Dex | Experimental | 25% MTD Dextromethorphan Receives: Drug: Dextromethorphan |
| 50% MTD Dex | Experimental | 50% MTD Dextromethorphan Receives: Drug: Dextromethorphan |
| 100% MTD Dex | Experimental | 100% MTD Dextromethorphan Receives: Drug: Dextromethorphan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Pain Intensity (Percent Change From Baseline)
Primary outcome was percent change from baseline in mean pain intensity (transformed Gracely Scale; 0-35). Baseline was defined as the week prior to randomization. The greater the percent change, the bigger the reduction in pain intensity.
Measured: 1st week of maintenance period (week prior to hospital admission for nested study; subjects traveled to Boston on days 6-7 of the maintenance period)
Secondary outcomes (1)
Satisfaction
Satisfaction with study treatment assessed over the 7 days prior to admission (5-point categorical scale)
Measured: Last week prior to admission (end of 1-week maintenance period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine N. Sang, MD, MPH, Brigham and Women's Hospital
- Investigators
- Christine N. Sang, MD, MPH, Principal investigator, Translational Pain Research, Brigham and Women's Hospital (Disclosure: Patent)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435798
- Sponsor's protocol ID
- 2000p001387-A
- Other IDs
- R01NS041503
- Status last verified
- Nov 2025
- First submitted
- 15 Sep 2011
- Last updated
- 8 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 Dose Response Clinical Trial
- ClinicalTrials.gov ID
- NCT01435798
- Acronym / sponsor ID
- 2000p001387-A
- 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
- 19 Sep 2011 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of three doses of chronic oral (PO) dextromethorphan compared to placebo in central neuropathic pain following spinal cord injury. Subjects' maximally tolerated doses (MTD) were first determined to establish individual dose-analgesic response relationships in a run-in period; following a washout period, subjects were then randomized to receive an order of four doses of dextromethorphan (including placebo) in a 4x4 Latin square cross-over design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0% MTD Dex | Placebo comparator | Drug: Dextromethorphan0% MTD Dextromethorphan |
| 25% MTD Dex | Experimental | Drug: Dextromethorphan25% MTD Dextromethorphan |
| 50% MTD Dex | Experimental | Drug: Dextromethorphan50% MTD Dextromethorphan |
| 100% MTD Dex | Experimental | Drug: Dextromethorphan100% MTD Dextromethorphan |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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:
- Postmenopausal women, or be physically incapable of childbearing, or be practicing an acceptable method of birth control.
- Normal cognitive function.
Key exclusion criteria (11 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 |
|---|---|---|
| Dextromethorphan0, 25, 50 and 100% of maximum tolerated dose, each administered over a 4 week period | Drug | 0% MTD Dex, 100% MTD Dex, 25% MTD Dex, 50% MTD Dex |
Primary outcome
Mean Pain Intensity (Percent Change From Baseline)
Time frame: 1st week of maintenance period (week prior to hospital admission for nested study; subjects traveled to Boston on days 6-7 of the maintenance period)
Primary outcome was percent change from baseline in mean pain intensity (transformed Gracely Scale; 0-35). Baseline was defined as the week prior to randomization. The greater the percent change, the bigger the reduction in pain intensity.
1 secondary outcome
Satisfaction
Time frame: Last week prior to admission (end of 1-week maintenance period)
Results and safety
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.
Related trials for Central Neuropathic Pain
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
Recruiting
Effect of TMS on Neuropathic Pain for Patients With Spinal Cord Injury
Spinal Cord Injury, Neuropathic Pain
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
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 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 10 inclusion and 11 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 4 Apr 2017). 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?
Mean Pain Intensity (Percent Change From Baseline) (time frame: 1st week of maintenance period (week prior to hospital admission for nested study; subjects traveled to Boston on days 6-7 of the maintenance period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.