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Table 3 Summary of main secondary variables at week 16 (end of treatment); intention to treat and LOCF analysis.

From: A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of neramexane in patients with moderate to severe subjective tinnitus

Variable (range)

Placebo (N= 111)

25 mg/d Neramexane (N= 106)

50 mg/d Neramexane (N= 106)

75 mg/d Neramexane (N= 99)

THI-12 Emotional-cognitive subscore

(0-14)

-1.7 ± 2.45

-1.2 ± 2.50 0.145

-2.0 ± 2.64 0.388

-1.8 ± 2.59 0.645

THI-12 Functional-communicational subscore

(0-10)

-0.7 ± 1.75

-0.7 ± 1.47 0.859

-1.2 ± 1.96 0.021*

-1.1 ± 1.77 0.097

Tinnitus loudness/severity

(0-10)

-0.7 ± 1.64

-0.4 ± 1.51 0.279

-0.9 ± 2.05 0.212

-0.9 ± 1.56 0.233

Tinnitus annoyance

(0-10)

-0.8 ± 2.04

-0.8 ± 1.95 0.639

-1.3 ± 2.26 0.043*

-0.8 ± 1.85 0.494

Tinnitus impact on life

(0-10)

-1.0 ± 1.98

-0.6 ± 1.89 0.335

-1.4 ± 2.61 0.038*

-0.8 ± 2.04 0.924

Tinnitus as a problem

(0-10)

-1.1 ± 1.86

-0.6 ± 1.72 0.058

-1.3 ± 2.42 0.328

-0.9 ± 2.05 0.951

Hyperacusis as a problem

(0-10)

-0.7 ± 2.51

-0.5 ± 2.49 0.271

-0.8 ± 2.72 0.778

-0.8 ± 1.85 0.666

Hearing as a problem

(0-10)

-0.2 ± 1.65

-0.0 ± 2.01 0.782

-0.7 ± 1.89 0.088

-0.1 ± 1.86 0.863

CGIC % improvement

27.9

22.6

34.0

38.4

  1. Mean ± SD and p-values for changes, * p < 0.05 favoring treatment
  2. (ANCOVA with treatment and center as factor, baseline as covariate).
  3. Negative values indicate improvements.