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Table 2 Demographic and clinical characteristics for patients entering the open-label versus double-blind phasea

From: Challenges recruiting to a proof-of-concept pharmaceutical trial for a rare disease: the trigeminal neuralgia experience

Characteristic

Open-label phase

(n = 67)

Double-blind phase

(n = 29)

Age (years)

 Mean (SD)

58.7 (12.4)

55.3 (14.0)

 Median (range)

60 (21–79)

56 (21–74)

Sex, n (%)

 Male

23 (34.3)

10 (34.5)

 Female

44 (65.7)

19 (65.5)

Height (cm)

  

 Mean (SD)

167.3 (9.4)

167.3 (9.0)

 Median (range)

165.0 (144–193)

165.0 (144–186)

Weight (kg)

 Mean (SD)

74.8 (14.3)

76.1 (13.4)

 Median (range)

73.0 (47–107)

74.0 (55–107)

BMI (kg/m2)

 Mean (SD)

26.6 (3.9)

27.1 (3.8)

 Median (range)

25.9 (19–35)

27.2 (22–33)

Race, n (%)

 White

64 (95.5)

28 (96.6)

 African American/African heritage

1 (1.5)

1 (3.4)

 Mixed race

2 (3.0)

0

TN duration (years), median (range)

6 (0–35)

6 (1–17)

Number of previous therapies for TN, median (range)

2 (1–25)

1 (1–6)

Anatomical site of TN pain, n (%)

  

 First branch

1 (2)

1 (3)

 Second branch

17 (25)

9 (31)

 Third branch

17 (25)

7 (24)

 First and second branches

5 (8)

3 (10)

 First, second, and third branches

7 (10)

2 (7)

 Second and third branches

20 (30)

7 (24)

  1. BMI body mass index, SD standard deviation, TN trigeminal neuralgia
  2. aFull study population published in [16]