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1-amino-alkylcyclohexane derivatives for the treatment of cognitive impairment in tinnitus

A technology for cognitive impairment and derivatives, applied in the direction of drug combinations, medical preparations containing active ingredients, organic active ingredients, etc., can solve problems such as no treatment methods

Inactive Publication Date: 2011-07-13
MERZ PHARMA GMBH & CO KGAA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

No treatment is proven to treat both tinnitus and cognitive impairment in tinnitus patients

Method used

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  • 1-amino-alkylcyclohexane derivatives for the treatment of cognitive impairment in tinnitus
  • 1-amino-alkylcyclohexane derivatives for the treatment of cognitive impairment in tinnitus
  • 1-amino-alkylcyclohexane derivatives for the treatment of cognitive impairment in tinnitus

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0165] Formulation Example 1: Neramexane mesylate immediate release tablet

[0166] The following table gives the composition of neramexane immediate release tablets in doses of 12.5, 25.0, 37.5, and 50.0 mg, including active ingredient, coating and other excipients.

[0167] Table 1-12.5mg Neramexane mesylate film-coated tablet

[0168]

[0169] Table 2-25.0mg Neramexane mesylate film-coated tablet

[0170]

[0171] Table 3-37.5mg Neramexane mesylate film-coated tablet

[0172] components

Dosage [mg]

effect

Neramexane mesylate

37.50

active pharmaceutical ingredient

microcrystalline cellulose

309.75

Adhesive

Croscarmellose Sodium

18.75

disintegrant

Silica (colloid)

3.75

flow enhancer

talc

3.75

Glidant

Magnesium stearate

1.50

lubricant

Tablet weight

375.00

Coating (HPMC), Opadry or Sepifilm

15.00

coating

Coating weight

...

Embodiment

[0176] The following examples illustrate the invention without limiting its scope.

[0177] Example 1: Double-blind placebo-controlled trial of Neramexane in the treatment of tinnitus

[0178] The purpose of this pilot program is to conduct a clinical trial to evaluate the efficacy of neramexane in the treatment of tinnitus. The primary objective of this study was to compare the efficacy, tolerability, and safety of three different doses (25, 50, or 75 mg / day) of neramexane mesylate in subjects with at least moderate subjective tinnitus. placebo for comparison.

[0179] Research design

[0180] The efficacy of neramexane was evaluated in subjects afflicted with at least moderate tinnitus in a double-blind, multicentre, randomized, placebo-controlled, parallel-group study. Approximately 100 patients (those who met specific inclusion criteria and did not meet any of the specific exclusion criteria) were randomized into 4 double-blind treatment groups (25, 50, 75 mg / day nerame...

Embodiment 2

[0225] Example 2: Double-blind placebo-controlled trial of Neramexane in the treatment of cognitive impairment associated with tinnitus

[0226] The purpose of this trial program is to conduct a clinical trial to further evaluate the sustained efficacy of neramexane in the treatment of tinnitus and associated cognitive impairment. The primary objective of this study was to compare the efficacy, tolerability and safety of neramexane mesylate with placebo in subjects with first-onset, persistent, unilateral or bilateral subjective tinnitus.

[0227] Research design

[0228] The efficacy of neramexane was evaluated in subjects with tinnitus in a double-blind, multicentre, randomized, placebo-controlled, parallel-group study. Patients who fully meet specified inclusion criteria and who do not meet any of the specified exclusion criteria are randomized into double-blind treatment groups.

[0229] Subjects were treated with neramexane or placebo for 29 weeks, which included a 4-week...

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PUM

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Abstract

The present invention relates to the treatment of an individual afflicted with cognitive impairment associated with tinnitus comprising administering to the individual an effective amount of a 1-amino-alkylcyclohexane derivative.

Description

field of invention [0001] The present invention relates to the treatment of an individual with cognitive impairment associated with tinnitus comprising administering to said individual an effective amount of a 1-amino-alkylcyclohexane derivative. Background of the invention [0002] The present invention relates to methods of treatment for patients with cognitive impairment associated with tinnitus. [0003] Tinnitus is commonly referred to as "ringing in the ears" - a sensation of sound produced in the absence of an exogenous acoustic signal. Tinnitus is defined as "sound sensation in the cochlea produced solely by activity within the nervous system without any corresponding mechanical, vibratory activity, i.e. tinnitus-like sensation of auditory hallucinations" (Jastreboff et al., J Am Acad Audiol 2000;11(3):162-177). [0004] The pathophysiology of subjective tinnitus is poorly understood, and a definitive pathogenesis of tinnitus has not been identified. Many environm...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/13A61K45/06A61P27/16A61P25/28
CPCA61K31/13A61K45/06A61P25/00A61P25/28A61P27/16A61K2300/00A61K31/137
Inventor T·罗森伯格H·克鲁格B·艾勒斯伦兹R·高尔特尔梅耶M·阿尔特豪斯
Owner MERZ PHARMA GMBH & CO KGAA