Table 1 Baseline characteristics of trial patients

From: A phase I/IIa safety and efficacy trial of intratympanic gamma-secretase inhibitor as a regenerative drug treatment for sensorineural hearing loss

 

Phase I

Phase IIa

Dose level

µg

25, 125, 200, 250

250

Number of participants

N

15

44

Age

Median (years)

60

58

 

Min - Max (years)

22–79

32–73

Gender

Female

7 (46.7%)

15 (34.1%)

 

Male

8 (53.3%)

29 (65.9%)

Years of schooling

Median (years)

16

16

 

Min - Max (years)

12–20

8–24

Education

Primary schooling only

0 (0%)

1 (2.3%)

 

Secondary schooling

5 (33.3%)

20 (45.5%)

 

Tertiary / higher education

10 (66.7%)

23 (52.3%)

Severity of hearing loss

Mild

9 (60%)

14 (33.3%)

 

Moderate

6 (40%)

29 (66.7%)

 

Mean Pure-Tone HLA 2,4,8 kHz

49.1 ± 12.6 HL

55.3 ± 9.3 HL

Duration of hearing loss

Range (yrs)

0–10

0–19

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