Table 2 Patient demographic and clinical characteristics at time of screening (n = 61).

From: Randomised, double-blind, placebo-controlled, parallel-group, multicentric, phase IIA clinical trial for evaluating the safety, tolerability, and therapeutic efficacy of daily oral administration of NFX88 to treat neuropathic pain in individuals with spinal cord injury

 

0.00 g/day

1.05 g/day

2.10 g/day

4.20 g/day

NFX88

 

(N = 15)

(N = 15)

(N = 15)

(N = 16)

(N = 46)

Age

     

  Mean (SD)

47.4 (13.4)

51.0 (12.8)

48.7 (10.8)

41.7 (11.6)

47 (12.17)

Gender

     

  Female

6 (40.0%)

1 (6.7%)

3 (20.0%)

2 (12.5%)

6 (13%)

  Male

9 (60.0%)

14 (93.3%)

12 (80.0%)

14 (87.5%)

40 (87%)

Ethnicity

     

  Caucasian

15 (100%)

13 (86.7%)

14 (93.3%)

16 (100%)

43 (93.48%)

  Black

0 (0%)

1 (6.7%)

0 (0%)

0 (0%)

1 (2.17%)

  Asian

0 (0%)

0 (0%)

0 (0%)

0 (0%)

0 (0%)

  Hispanic

0 (0%)

1 (6.7%)

1 (6.7%)

0 (0%)

2 (4.35%)

  Other

0 (0%)

0 (0%)

0 (0%)

0 (0%)

0 (0%)

Weight

     

  Mean (SD)

74.0 (15.3)

82.0 (12.1)

78.2 (11.8)

81.0 (11.6)

80.45 (11.7)

Years since lesion started

     

  Mean (SD)

9.93 (12.87)

9.57 (10.31)

8.78 (9.24)

6.26 (5.93)

8.16 (8.57)

Years since illness started

     

  Mean (SD)

9.47 (13.1)

5.67 (8.53)

5.93 (9.83)

5.76 (5.94)

5.78 (7.98)

Neurological level

     

  Paraplegia

8 (53.33%)

11 (73.33%)

11 (73.33)

12 (75%)

34 (74%)

  Tetraplegia

7 (46.67%)

4 (26.67)

4 (26.67%)

4 (25%)

12 (26%)

AIS score

     

  A: Complete

7 (46.67%)

11 (73..33%)

8 (53.33%)

11 (68.75%)

30 (65.2%)

  B: Incomplete

1 (6.67%)

0 (0%)

1 (6.67%)

1 (6.25%)

2 (4.34%)

  C: Incomplete

0 (0%)

0 (0%)

2 (13.33%)

1 (6.25%)

3 (6.5%)

  D: Incomplete

7 (46.67%)

4 (26.67%)

4 (26.67%)

3 (18.75%)

12 (26.1%)

  E: Normal

0 (0%)

0 (0%)

0 (0%)

0 (0%)

0 (0%)

VAS

     

  Mean (SD)

6.96 (1.48)

7.02 (1.54)

6.38 (1.91)

6.86 (1.52)

6.76 (1.65)

  Median [Min, Max]

6.7 [4.00, 9.60]

7.00 [4.50, 10.00]

6.50 [4.00, 10.0]

7.00 [4.4, 9.3]

7.00 [4.0, 10.0]

PDQF

     

  Mean (SD)

18.2 (4.51)

20.93 (6.40)

15.07 (7.44)

19.44 (7.73)

18.5 (7.49)

  Median [Min, Max]

18.0 [11.00, 27.0]

21.0 [11.00, 30.0]

12.0 [6.00, 35.0]

19.0 [6.00, 31.0]

18.0 [6.00, 35.0]

 Low probability

2 (13.33%)

1 (6.67%)

8 (53.33%)

4 (25%)

13 (28.26%)

 Intermediate probability

6 (40%)

6 (40%)

2 (13.33%)

4 (25%)

12 (26.08%)

 High probability

7 (46.67%)

8 (53.3%)

5 (33.33%)

8 (50%)

21 (45.65%)

  1. AIS Asia impairment scale, PDQF painDETECT questionnaire final score.
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