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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS041503 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0% MTD Dex | Placebo Comparator | 0% MTD Dextromethorphan |
|
| 25% MTD Dex | Experimental | 25% MTD Dextromethorphan |
|
| 50% MTD Dex | Experimental | 50% MTD Dextromethorphan |
|
| 100% MTD Dex | Experimental | 100% MTD Dextromethorphan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextromethorphan | Drug | 0, 25, 50 and 100% of maximum tolerated dose, each administered over a 4 week period |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction | Satisfaction with study treatment assessed over the 7 days prior to admission (5-point categorical scale) | Last week prior to admission (end of 1-week maintenance period) |
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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:
Postmenopausal women, or be physically incapable of childbearing, or be practicing an acceptable method of birth control.
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine N. Sang, MD, MPH | Translational Pain Research, Brigham and Women's Hospital (Disclosure: Patent) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Translational Pain Research, Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| Label | URL |
|---|---|
| Translational Pain Research, Brigham and Women's Hospital | View source |
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During the screening visit, P450 2D6 phenotype status was determined for each subject to identify drug-metabolizing capacity; those who were P450 2D6 poor-metabolizers were excluded. Following screen, each subject entered a dose escalation period to determine his/her maximum tolerated dose (MTD), prior to randomization.
Subjects were recruited nationally from referring physicians, through advertisements, and through existing databases.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dextromethorphan Dose Response (DDR) Clinical Trial | Each subject received four doses of dextromethorphan; 0% (placebo), 25%, 50%, and 100% of the maximum tolerated dose in a balanced randomized order. Each dose was administered for a period of 28 days; on day 21 of each phase, subjects traveled to the study site to undergo study procedures in a nested clinical trial (not described here). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dextromethorphan Dose Response Clinical Trial | Each subject received four doses of dextromethorphan; 0% (placebo), 25%, 50%, and 100% of the maximum tolerated dose in a balanced randomized order. Each dose was administered for a period of 28 days; on day 21 of each phase, subjects traveled to the study site to undergo study procedures in a nested clinical trial (not described here). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | Percent change from baseline | 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) |
|
Adverse event data were collected post-dose through the end of treatment in each arm.
All anticipated and unanticipated post-dose adverse events that were possibly, probably, or definitely related to the study drug are reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0% MTD Dex | 0% (placebo) of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitis | Ear and labyrinth disorders | Systematic Assessment | Not present at baseline, defined as:1) prior to randomization, in DDR; 2) Prior to lido infusion, on 100% Dex, in D/L. In DDR, all AEs were of mild intensity. In D/L, AEs were assessed at Cmax and were >= mild. No infusions were terminated for AEs. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine N. Sang, MD, MPH | Translational Pain Research, Brigham and Women's Hospital | 617-525-7246 | paintrials@partners.org |
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| ID | Term |
|---|---|
| D006930 | Hyperalgesia |
| D013119 | Spinal Cord Injuries |
| D059350 | Chronic Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003915 | Dextromethorphan |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
25% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
| OG002 | 50% MTD Dex | 50% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures. |
| OG003 | 100% MTD Dex | 100% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures. |
|
|
| Secondary | Satisfaction | Satisfaction with study treatment assessed over the 7 days prior to admission (5-point categorical scale) | Posted | Count of Participants | Participants | Last week prior to admission (end of 1-week maintenance period) |
|
|
|
| 0 |
| 25 |
| 2 |
| 25 |
| EG001 | 25% MTD Dex | 25% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures. | 0 | 26 | 3 | 26 |
| EG002 | 50% MTD Dex | 50% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures. | 0 | 25 | 2 | 25 |
| EG003 | 100% MTD Dex | 100% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures. | 0 | 25 | 16 | 25 |
|
| Sedation | Nervous system disorders | Systematic Assessment | Not present at baseline, defined as:1) prior to randomization, in DDR; 2) Prior to lido infusion, on 100% Dex, in D/L. In DDR, all AEs were of mild intensity. In D/L, AEs were assessed at Cmax and were >= mild. No infusions were terminated for AEs. |
|
| Blurry Vision | Nervous system disorders | Systematic Assessment |
|
| Interference with Alertness | Nervous system disorders | Systematic Assessment |
|
| Interference with Ability to Drive | Nervous system disorders | Systematic Assessment |
|
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Fairly Satisfied |
|
| Satisfied |
|
| Very/Extremely Satisfied |
|