Trial Outcomes & Findings for D-cycloserine in the Management of Chronic Low Back Pain (NCT NCT00125528)

Results Overview

Change in NRS score after 6 weeks of treatment as compared to baseline. The numeric rating scale is an 11-point rating scale wherein participants rated their current lower back pain intensity on a scale from 0 to 10, with 0 meaning no pain and 10 being the worst pain possible. Thus, a larger negative number indicates positive change and a higher efficacy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

6 weeks

Results posted on

2017-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	D-cycloserine D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid	Placebo placebo: placebo bid
Overall Study STARTED	20	21
Overall Study COMPLETED	18	20
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

D-cycloserine in the Management of Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	D-cycloserine n=20 Participants D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid	Placebo n=21 Participants placebo: placebo bid	Total n=41 Participants Total of all reporting groups
Age, Continuous	54.65 years STANDARD_DEVIATION 11.56 • n=5 Participants	54.76 years STANDARD_DEVIATION 10.84 • n=7 Participants	54.71 years STANDARD_DEVIATION 11.06 • n=5 Participants
Gender Female	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Gender Male	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Numeric Rating Scale (NRS-11)	6.47 units on a scale STANDARD_DEVIATION 1.40 • n=5 Participants	6.6 units on a scale STANDARD_DEVIATION 1.50 • n=7 Participants	6.54 units on a scale STANDARD_DEVIATION 1.45 • n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Change in NRS score after 6 weeks of treatment as compared to baseline. The numeric rating scale is an 11-point rating scale wherein participants rated their current lower back pain intensity on a scale from 0 to 10, with 0 meaning no pain and 10 being the worst pain possible. Thus, a larger negative number indicates positive change and a higher efficacy.

Outcome measures

Outcome measures
Measure	D-cycloserine n=18 Participants D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid	Placebo n=20 Participants placebo: placebo bid
Change in Numeric Rating Scale (NRS-11)	-2.47 units on a scale Standard Deviation 0.50	-1.55 units on a scale Standard Deviation 0.50

SECONDARY outcome

Timeframe: 6 weeks

Change in MPQ score after 6 weeks of treatment as compared to baseline. The MPQ score uses a Pain Rating Index from 0 to 20 where 0 is evidence of no pain and 20 indicates the highest pain possible. A lower score is also indicative of a lower quality of pain. Thus, a larger negative number indicates positive change and therefore higher efficacy.

Outcome measures

Outcome measures
Measure	D-cycloserine n=18 Participants D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid	Placebo n=20 Participants placebo: placebo bid
McGill Pain Questionnaire (MPQ)	-2.80 units on a scale Standard Deviation 0.66	-1.00 units on a scale Standard Deviation 0.66

Adverse Events

D-cycloserine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	D-cycloserine n=20 participants at risk D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid	Placebo n=21 participants at risk placebo: placebo bid
General disorders Headache	5.0% 1/20 • Number of events 1	14.3% 3/21 • Number of events 3
Skin and subcutaneous tissue disorders Lower Extremity Edema	0.00% 0/20	9.5% 2/21 • Number of events 2
Nervous system disorders Numbness/Tingling	15.0% 3/20 • Number of events 3	0.00% 0/21

Additional Information

Dr. Thomas Schnitzer

Northwestern Universiyt

Phone: 312-503-2315

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place