Trial Outcomes & Findings for D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain (NCT NCT03535688)
NCT ID: NCT03535688
Last Updated: 2026-05-04
Results Overview
Mean pain levels will be assessed at study baseline and compared to mean pain levels at Week 12 (study efficacy endpoint). Pain will be assessed using an 11-point NRS scale.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
203 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-05-04
Participant Flow
There was an error in the study drug dispensation process that resulted in the incorrect treatment assignment being dispensed. Adverse events are reported for all participants who were randomized (n=203) based on the treatment received (safety population). For the primary efficacy outcome results, only those participants who were enrolled up to the time of the error in allocation were included in those analyses (n=170).
Participant milestones
| Measure |
D-cycloserine (Secondary)
The participants in this group were incorrectly randomized to D-cycloserine. They were excluded from efficacy analyses, but were included in safety analyses.
|
Placebo (Secondary)
The participants in this group were incorrectly randomized to Placebo. They were excluded from efficacy analyses, but were included in safety analyses.
|
D-cycloserine
D-cycloserine 200 mg twice daily
|
Placebo
Placebo twice daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
6
|
86
|
84
|
|
Overall Study
COMPLETED
|
19
|
6
|
57
|
62
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
29
|
22
|
Reasons for withdrawal
| Measure |
D-cycloserine (Secondary)
The participants in this group were incorrectly randomized to D-cycloserine. They were excluded from efficacy analyses, but were included in safety analyses.
|
Placebo (Secondary)
The participants in this group were incorrectly randomized to Placebo. They were excluded from efficacy analyses, but were included in safety analyses.
|
D-cycloserine
D-cycloserine 200 mg twice daily
|
Placebo
Placebo twice daily
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
0
|
9
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
11
|
7
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
3
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
6
|
3
|
|
Overall Study
Study Terminated Early
|
0
|
0
|
0
|
6
|
Baseline Characteristics
D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain
Baseline characteristics by cohort
| Measure |
D-cycloserine
n=86 Participants
D-cycloserine 200 mg twice daily
|
Placebo
n=84 Participants
Placebo twice daily
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.95 years
STANDARD_DEVIATION 14.28 • n=54 Participants
|
56.07 years
STANDARD_DEVIATION 15.42 • n=60 Participants
|
56.01 years
STANDARD_DEVIATION 14.81 • n=114 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=54 Participants
|
39 Participants
n=60 Participants
|
85 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=54 Participants
|
45 Participants
n=60 Participants
|
85 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=54 Participants
|
8 Participants
n=60 Participants
|
21 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=54 Participants
|
74 Participants
n=60 Participants
|
145 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=54 Participants
|
7 Participants
n=60 Participants
|
12 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=54 Participants
|
28 Participants
n=60 Participants
|
62 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=54 Participants
|
40 Participants
n=60 Participants
|
83 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=54 Participants
|
7 Participants
n=60 Participants
|
10 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=54 Participants
|
84 participants
n=60 Participants
|
170 participants
n=114 Participants
|
|
Pain Numeric Rating Scale (NRS)
|
6.00 units on a scale
STANDARD_DEVIATION 1.37 • n=54 Participants
|
5.95 units on a scale
STANDARD_DEVIATION 1.36 • n=60 Participants
|
5.97 units on a scale
STANDARD_DEVIATION 4.36 • n=114 Participants
|
|
painDETECT
|
11.34 units on a scale
STANDARD_DEVIATION 7.04 • n=54 Participants
|
11.88 units on a scale
STANDARD_DEVIATION 6.58 • n=60 Participants
|
11.61 units on a scale
STANDARD_DEVIATION 6.79 • n=114 Participants
|
|
Positive and Negative Affect Schedule (PANAS) Positive
|
33.66 units on a scale
STANDARD_DEVIATION 6.01 • n=54 Participants
|
32.27 units on a scale
STANDARD_DEVIATION 6.83 • n=60 Participants
|
32.97 units on a scale
STANDARD_DEVIATION 8.32 • n=114 Participants
|
|
Positive and Negative Affect Schedule (PANAS) Negative
|
17.28 units on a scale
STANDARD_DEVIATION 6.66 • n=54 Participants
|
17.04 units on a scale
STANDARD_DEVIATION 6.15 • n=60 Participants
|
17.16 units on a scale
STANDARD_DEVIATION 6.39 • n=114 Participants
|
|
Beck Depression Inventory (BDI)
|
6.63 units on a scale
STANDARD_DEVIATION 6.10 • n=54 Participants
|
8.00 units on a scale
STANDARD_DEVIATION 7.75 • n=60 Participants
|
7.31 units on a scale
STANDARD_DEVIATION 6.98 • n=114 Participants
|
|
Pain Catastrophizing Scale (PCS)
|
13.44 units on a scale
STANDARD_DEVIATION 11.05 • n=54 Participants
|
12.72 units on a scale
STANDARD_DEVIATION 11.03 • n=60 Participants
|
13.06 units on a scale
STANDARD_DEVIATION 11.00 • n=114 Participants
|
|
Oswestry Disability Index (ODI)
|
31.26 units on a scale
STANDARD_DEVIATION 14.32 • n=54 Participants
|
31.93 units on a scale
STANDARD_DEVIATION 16.24 • n=60 Participants
|
31.59 units on a scale
STANDARD_DEVIATION 15.25 • n=114 Participants
|
|
SF-12 Mental Health
|
62.43 units on a scale
STANDARD_DEVIATION 13.46 • n=54 Participants
|
60.29 units on a scale
STANDARD_DEVIATION 13.81 • n=60 Participants
|
61.36 units on a scale
STANDARD_DEVIATION 13.63 • n=114 Participants
|
|
SF-12 Physical Health
|
43.09 units on a scale
STANDARD_DEVIATION 12.35 • n=54 Participants
|
42.39 units on a scale
STANDARD_DEVIATION 12.31 • n=60 Participants
|
42.74 units on a scale
STANDARD_DEVIATION 12.33 • n=114 Participants
|
|
Patient Global Assessment (PGA) of Low Back Pain
|
2.61 units on a scale
STANDARD_DEVIATION 0.58 • n=54 Participants
|
2.63 units on a scale
STANDARD_DEVIATION 0.62 • n=60 Participants
|
2.62 units on a scale
STANDARD_DEVIATION 0.59 • n=114 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
Mean pain levels will be assessed at study baseline and compared to mean pain levels at Week 12 (study efficacy endpoint). Pain will be assessed using an 11-point NRS scale.
Outcome measures
| Measure |
D-cycloserine (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Placebo (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
D-cycloserine
n=86 Participants
D-cycloserine 200 mg twice daily
|
Placebo
n=84 Participants
Placebo twice daily
|
Male (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Female (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
|---|---|---|---|---|---|---|
|
Change in Numeric Rating Scale (NRS) Pain Score 0-10; Higher Worse
|
—
|
—
|
4.62 units on a scale
Standard Error 1.94
|
4.70 units on a scale
Standard Error 2.27
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
Assess the effect of gender on the on the pain rating response in each group (pain rating scale: 0 (no pain) to 10 (highest pain)).
Outcome measures
| Measure |
D-cycloserine (Secondary)
n=34 Participants
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Placebo (Secondary)
n=37 Participants
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
D-cycloserine
n=33 Participants
D-cycloserine 200 mg twice daily
|
Placebo
n=37 Participants
Placebo twice daily
|
Male (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Female (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
|---|---|---|---|---|---|---|
|
Effect of Gender on Magnitude of Pain Response.
|
4.4 units on a scale
Standard Deviation 2.3
|
3.68 units on a scale
Standard Deviation 3.03
|
4.87 units on a scale
Standard Deviation 2.38
|
4.29 units on a scale
Standard Deviation 2.48
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksEvaluate interaction between the primary endpoint and specified brain biomarkers, with particular attention to corticostriatal connectivity. Whole-brain exploratory analyses will also be used to identify both brain predictors or treatment response and brain reorganization in response to treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
A 5-point scale used to reflect the global impact of pain from the patient's perspective. Scale range 0-10; higher = worse.
Outcome measures
| Measure |
D-cycloserine (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Placebo (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
D-cycloserine
n=86 Participants
D-cycloserine 200 mg twice daily
|
Placebo
n=84 Participants
Placebo twice daily
|
Male (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Female (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
|---|---|---|---|---|---|---|
|
Patient Global Assessment
|
—
|
—
|
2.43 score on a scale
Standard Deviation 0.66
|
2.50 score on a scale
Standard Deviation 0.52
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
A 7-point self-report measure that reflects a patient's belief about the efficacy of treatment; by depicting a patient's rating of overall improvement. Scale range 1-7, higher = worse.
Outcome measures
| Measure |
D-cycloserine (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Placebo (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
D-cycloserine
n=86 Participants
D-cycloserine 200 mg twice daily
|
Placebo
n=84 Participants
Placebo twice daily
|
Male (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Female (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
|---|---|---|---|---|---|---|
|
Patient Global Impression of Change
|
—
|
—
|
2.96 score on a scale
Standard Deviation 0.95
|
3.69 score on a scale
Standard Deviation 1.01
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
A 17-item self-reported measure assessing both the quality and intensity of subjective pain. Score 0-45, higher worse
Outcome measures
| Measure |
D-cycloserine (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Placebo (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
D-cycloserine
n=86 Participants
D-cycloserine 200 mg twice daily
|
Placebo
n=84 Participants
Placebo twice daily
|
Male (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Female (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
|---|---|---|---|---|---|---|
|
McGill Pain Questionnaire (MPQ)
|
—
|
—
|
10.71 score on a scale
Standard Deviation 8.55
|
9.15 score on a scale
Standard Deviation 7.63
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
A 14-item self-reported measure assessing qualities for pain of neuropathic origin to distinguish pain severity. Score 0-38; higher more neuropathic
Outcome measures
| Measure |
D-cycloserine (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Placebo (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
D-cycloserine
n=86 Participants
D-cycloserine 200 mg twice daily
|
Placebo
n=84 Participants
Placebo twice daily
|
Male (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Female (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
|---|---|---|---|---|---|---|
|
PainDETECT Questionnaire (PDQ)
|
—
|
—
|
8.87 score on a scale
Standard Deviation 5.74
|
9.06 score on a scale
Standard Deviation 5.44
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weekPopulation: The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
A 21-item self-report rating inventory that measures characteristic attitudes and symptoms of depression. Score 0-63, higher worse
Outcome measures
| Measure |
D-cycloserine (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Placebo (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
D-cycloserine
n=86 Participants
D-cycloserine 200 mg twice daily
|
Placebo
n=84 Participants
Placebo twice daily
|
Male (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Female (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
|---|---|---|---|---|---|---|
|
Beck Depression Inventory (BDI)
|
—
|
—
|
8.35 score on a scale
Standard Deviation 7.95
|
7.78 score on a scale
Standard Deviation 9.04
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
A self-report questionnaire consisting of two 10-item (5-point) scales to measure both positive and negative affects of pain. Score 10-50; higher more positive
Outcome measures
| Measure |
D-cycloserine (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Placebo (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
D-cycloserine
n=86 Participants
D-cycloserine 200 mg twice daily
|
Placebo
n=84 Participants
Placebo twice daily
|
Male (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Female (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
|---|---|---|---|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) - Positive
|
—
|
—
|
32.90 score on a scale
Standard Deviation 8.28
|
32.25 score on a scale
Standard Deviation 9.59
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
A 13-item scale assessing the degree of catastrophic cognitions in the sensation of pain. The scale ranges from 1 (not at all) to 4 (always). Score 0-52, higher worse
Outcome measures
| Measure |
D-cycloserine (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Placebo (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
D-cycloserine
n=86 Participants
D-cycloserine 200 mg twice daily
|
Placebo
n=84 Participants
Placebo twice daily
|
Male (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Female (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
|---|---|---|---|---|---|---|
|
Pain Catastrophizing Scale (PCS)
|
—
|
—
|
12.26 score on a scale
Standard Deviation 11.51
|
10.97 score on a scale
Standard Deviation 11.97
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksA 32-item self-reported measure delineating between beneficial versus maladaptive interoceptive attention. Score 0-160, higher more awareness.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
A 10-item self-reported measure quantifying a subjective percentage score of level of function (disability) in activities of daily living in those with chronic low back pain. Score 0-50; higher is greater disability
Outcome measures
| Measure |
D-cycloserine (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Placebo (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
D-cycloserine
n=86 Participants
D-cycloserine 200 mg twice daily
|
Placebo
n=84 Participants
Placebo twice daily
|
Male (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Female (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
|---|---|---|---|---|---|---|
|
Oswestry Disability Index (ODI)
|
—
|
—
|
26.19 score on a scale
Standard Deviation 15.50
|
18.67 score on a scale
Standard Deviation 15.50
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
A 12-item self-report questionnaire measuring functional health and well-being from the patient's point of view. The SF-12 measures patient reported, health related quality of life from 0 to 100, with higher scores indicating better physical and mental health functioning.
Outcome measures
| Measure |
D-cycloserine (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Placebo (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
D-cycloserine
n=86 Participants
D-cycloserine 200 mg twice daily
|
Placebo
n=84 Participants
Placebo twice daily
|
Male (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Female (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
|---|---|---|---|---|---|---|
|
12-Item Short Form Survey (SF-12) - Mental
|
—
|
—
|
61.14 score on a scale
Standard Deviation 13.46
|
60.23 score on a scale
Standard Deviation 14.10
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
A self-report questionnaire consisting of two 10-item (5-point) scales to measure both positive and negative affects of pain. Score 10-50; higher more positive
Outcome measures
| Measure |
D-cycloserine (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Placebo (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
D-cycloserine
n=86 Participants
D-cycloserine 200 mg twice daily
|
Placebo
n=84 Participants
Placebo twice daily
|
Male (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Female (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
|---|---|---|---|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) - Negative
|
—
|
—
|
17.54 score on a scale
Standard Deviation 5.92
|
16.79 score on a scale
Standard Deviation 7.10
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
A 12-item self-report questionnaire measuring functional health and well-being from the patient's point of view. The SF-12 measures patient reported, health related quality of life from 0 to 100, with higher scores indicating better physical and mental health functioning.
Outcome measures
| Measure |
D-cycloserine (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Placebo (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
D-cycloserine
n=86 Participants
D-cycloserine 200 mg twice daily
|
Placebo
n=84 Participants
Placebo twice daily
|
Male (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
Female (Secondary)
The participants in the secondary sample were incorrectly randomized. They were excluded from efficacy analyses, but were included in safety analyses.
|
|---|---|---|---|---|---|---|
|
12-Item Short Form Survey (SF-12) - Physical
|
—
|
—
|
44.02 score on a scale
Standard Deviation 13.81
|
44.45 score on a scale
Standard Deviation 14.00
|
—
|
—
|
Adverse Events
D-cycloserine
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
D-cycloserine
n=113 participants at risk
D-cycloserine 200 mg twice daily
|
Placebo
n=90 participants at risk
Placebo twice daily
|
|---|---|---|
|
Vascular disorders
Stroke
|
0.88%
1/113 • Number of events 1 • AEs were collected throughout the entire study period, starting on screening (visit 1) to week 24 (final visit).
Adverse events are reported for all participants who were randomized (n=203) based on the treatment received (safety population). For the primary efficacy outcome results, only those participants who were enrolled up to the time of the error in allocation were included in those analyses (n=170).
|
1.1%
1/90 • Number of events 1 • AEs were collected throughout the entire study period, starting on screening (visit 1) to week 24 (final visit).
Adverse events are reported for all participants who were randomized (n=203) based on the treatment received (safety population). For the primary efficacy outcome results, only those participants who were enrolled up to the time of the error in allocation were included in those analyses (n=170).
|
|
Infections and infestations
Severe COVID-19 Infection
|
0.00%
0/113 • AEs were collected throughout the entire study period, starting on screening (visit 1) to week 24 (final visit).
Adverse events are reported for all participants who were randomized (n=203) based on the treatment received (safety population). For the primary efficacy outcome results, only those participants who were enrolled up to the time of the error in allocation were included in those analyses (n=170).
|
2.2%
2/90 • Number of events 2 • AEs were collected throughout the entire study period, starting on screening (visit 1) to week 24 (final visit).
Adverse events are reported for all participants who were randomized (n=203) based on the treatment received (safety population). For the primary efficacy outcome results, only those participants who were enrolled up to the time of the error in allocation were included in those analyses (n=170).
|
|
Musculoskeletal and connective tissue disorders
Severe Back Pain
|
0.00%
0/113 • AEs were collected throughout the entire study period, starting on screening (visit 1) to week 24 (final visit).
Adverse events are reported for all participants who were randomized (n=203) based on the treatment received (safety population). For the primary efficacy outcome results, only those participants who were enrolled up to the time of the error in allocation were included in those analyses (n=170).
|
1.1%
1/90 • Number of events 1 • AEs were collected throughout the entire study period, starting on screening (visit 1) to week 24 (final visit).
Adverse events are reported for all participants who were randomized (n=203) based on the treatment received (safety population). For the primary efficacy outcome results, only those participants who were enrolled up to the time of the error in allocation were included in those analyses (n=170).
|
|
Surgical and medical procedures
Total Knee Replacement
|
0.88%
1/113 • Number of events 1 • AEs were collected throughout the entire study period, starting on screening (visit 1) to week 24 (final visit).
Adverse events are reported for all participants who were randomized (n=203) based on the treatment received (safety population). For the primary efficacy outcome results, only those participants who were enrolled up to the time of the error in allocation were included in those analyses (n=170).
|
0.00%
0/90 • AEs were collected throughout the entire study period, starting on screening (visit 1) to week 24 (final visit).
Adverse events are reported for all participants who were randomized (n=203) based on the treatment received (safety population). For the primary efficacy outcome results, only those participants who were enrolled up to the time of the error in allocation were included in those analyses (n=170).
|
Other adverse events
| Measure |
D-cycloserine
n=113 participants at risk
D-cycloserine 200 mg twice daily
|
Placebo
n=90 participants at risk
Placebo twice daily
|
|---|---|---|
|
Nervous system disorders
Headache
|
5.3%
6/113 • Number of events 6 • AEs were collected throughout the entire study period, starting on screening (visit 1) to week 24 (final visit).
Adverse events are reported for all participants who were randomized (n=203) based on the treatment received (safety population). For the primary efficacy outcome results, only those participants who were enrolled up to the time of the error in allocation were included in those analyses (n=170).
|
4.4%
4/90 • Number of events 4 • AEs were collected throughout the entire study period, starting on screening (visit 1) to week 24 (final visit).
Adverse events are reported for all participants who were randomized (n=203) based on the treatment received (safety population). For the primary efficacy outcome results, only those participants who were enrolled up to the time of the error in allocation were included in those analyses (n=170).
|
|
Infections and infestations
Upper Respiratory Infection
|
6.2%
7/113 • Number of events 7 • AEs were collected throughout the entire study period, starting on screening (visit 1) to week 24 (final visit).
Adverse events are reported for all participants who were randomized (n=203) based on the treatment received (safety population). For the primary efficacy outcome results, only those participants who were enrolled up to the time of the error in allocation were included in those analyses (n=170).
|
6.7%
6/90 • Number of events 6 • AEs were collected throughout the entire study period, starting on screening (visit 1) to week 24 (final visit).
Adverse events are reported for all participants who were randomized (n=203) based on the treatment received (safety population). For the primary efficacy outcome results, only those participants who were enrolled up to the time of the error in allocation were included in those analyses (n=170).
|
Additional Information
Dr. Santiago Espinosa Salas
Northwestern University Feinberg School of Medicine
Phone: 312 503 3283
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place