Trial Outcomes & Findings for Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical Trial (NCT NCT01435798)
NCT ID: NCT01435798
Last Updated: 2025-12-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
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)
Results posted on
2025-12-08
Participant Flow
Subjects were recruited nationally from referring physicians, through advertisements, and through existing databases.
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.
Participant milestones
| Measure |
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).
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|---|---|
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Overall Study
STARTED
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26
|
|
Overall Study
0% MTD
|
25
|
|
Overall Study
25% MTD
|
26
|
|
Overall Study
50% MTD
|
25
|
|
Overall Study
100% MTD
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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).
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|---|---|
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Overall Study
Withdrawal by Subject
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1
|
Baseline Characteristics
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical Trial
Baseline characteristics by cohort
| Measure |
Dextromethorphan Dose Response Clinical Trial
n=26 Participants
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).
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=9 Participants
|
|
Age, Continuous
|
46.84 years
STANDARD_DEVIATION 11.32 • n=9 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=9 Participants
|
|
Region of Enrollment
North America
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26 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
0% MTD Dex
n=25 Participants
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.
|
25% MTD Dex
n=26 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.
|
50% MTD Dex
n=25 Participants
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.
|
100% MTD Dex
n=25 Participants
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.
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|---|---|---|---|---|
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Mean Pain Intensity (Percent Change From Baseline)
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-0.006 Percent change from baseline
Standard Error 0.01
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-0.018 Percent change from baseline
Standard Error 0.005
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-0.073 Percent change from baseline
Standard Error 0.01
|
-0.24 Percent change from baseline
Standard Error 0.01
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SECONDARY outcome
Timeframe: Last week prior to admission (end of 1-week maintenance period)Satisfaction with study treatment assessed over the 7 days prior to admission (5-point categorical scale)
Outcome measures
| Measure |
0% MTD Dex
n=25 Participants
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.
|
25% MTD Dex
n=26 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.
|
50% MTD Dex
n=25 Participants
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.
|
100% MTD Dex
n=25 Participants
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.
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|---|---|---|---|---|
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Satisfaction
Not Satisfied
|
20 Participants
|
18 Participants
|
16 Participants
|
9 Participants
|
|
Satisfaction
Fairly Satisfied
|
2 Participants
|
5 Participants
|
7 Participants
|
8 Participants
|
|
Satisfaction
Satisfied
|
3 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
|
Satisfaction
Very/Extremely Satisfied
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
Adverse Events
0% MTD Dex
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
25% MTD Dex
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
50% MTD Dex
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
100% MTD Dex
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0% MTD Dex
n=25 participants at risk
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.
|
25% MTD Dex
n=26 participants at risk
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.
|
50% MTD Dex
n=25 participants at risk
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.
|
100% MTD Dex
n=25 participants at risk
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.
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|---|---|---|---|---|
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Ear and labyrinth disorders
Tinnitis
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0.00%
0/25 • 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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0.00%
0/26 • 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.
|
8.0%
2/25 • Number of events 2 • 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.
|
0.00%
0/25 • 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.
|
|
Nervous system disorders
Sedation
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0.00%
0/25 • 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.
|
0.00%
0/26 • 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.
|
0.00%
0/25 • 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.
|
32.0%
8/25 • Number of events 8 • 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.
|
|
Nervous system disorders
Blurry Vision
|
0.00%
0/25 • 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.
|
0.00%
0/26 • 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.
|
0.00%
0/25 • 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.
|
12.0%
3/25 • Number of events 3 • 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.
|
|
Nervous system disorders
Interference with Alertness
|
8.0%
2/25 • Number of events 2 • 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.
|
11.5%
3/26 • Number of events 3 • 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.
|
0.00%
0/25 • 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.
|
12.0%
3/25 • Number of events 3 • 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.
|
|
Nervous system disorders
Interference with Ability to Drive
|
0.00%
0/25 • 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.
|
0.00%
0/26 • 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.
|
0.00%
0/25 • 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.
|
8.0%
2/25 • Number of events 2 • 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.
|
Additional Information
Christine N. Sang, MD, MPH
Translational Pain Research, Brigham and Women's Hospital
Phone: 617-525-7246
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place