Trial · NCT00955799
Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus
NCT00955799, Phase 3, Completed, Merz Pharmaceuticals GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus. Trials, record NCT00955799. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00955799
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus
- NCT number
- NCT00955799
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 455 participants, actual
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Conditions
- Subjective Tinnitus
- Interventions
- Neramexane mesylate, Placebo
- First posted
- 2009-08-10
- Last updated
- 2012-11-28
- Other registries' IDs
- eudract:2009-011246-25
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change in TBF-12 (Tinnitus Handicap Inventory-12) Total Score from Baseline. | Baseline to week 17 and 29 | The TBF-12 is an adapted German version of the original English THI (Tinnitus Handicap Inventory). It is a self-report questionnaire assessing 12 items from 2 dimensions: emotional-cognitive factors and functional-communicational factors. Each item is rated with 0-2 (2= "often"; 1= "sometimes"; 0= "never"). The maximum score is 24 indicating most severe tinnitus impairment. Hierarchical test procedure: Step 1: week 29 in subjects reporting acute hearing loss; step 2: week 17, ditto; step 3: week 29 in total population; step 4: week 17, ditto. |
| Primary | Absolute Change in TSSw (Tinnitus Severity Scale - One Week Version) Total Score from Baseline. | Baseline to week 17 and 29 | The TSSw is a measure of tinnitus severity. It will be self-evaluated by the patient at various time points on an 11-point Likert-like scale asking for the past week. The scores range from 0 (indicating no tinnitus) to the maximum score of 10 (characterizing the most severe tinnitus considered). Hierarchical test procedure: Step 1: week 29 in subjects reporting acute hearing loss; step 2: week 17, ditto; step 3: week 29 in total population; step 4: week 17, ditto. |
| Secondary | TBF-12 Total Score: Change from Baseline | Baseline to week 5, 17, 23, and 29 | See outcome measure #1. |
| Secondary | TBF-12 Factorial Scores: Change from Baseline | Baseline to week 5, 17, 23, and 29 | See outcome measure #1. |
| Secondary | TBF-12: Individual Responder Rate | Week 5, 17, 23, and 29 | See outcome measure #1. A subject is considered responder if TBF-12 decreases at least 4 score points between baseline and respective visit. |
| Secondary | Tinnitus Rating Scale (one week version): Change from Baseline | Baseline to week 5, 17, 23, and 29 | Tinnitus Rating Scale is a self-evaluated 11-point Likert scale assessing tinnitus loudness, annoyance, and impact on life. The scores range from 0 (no impact), to the maximum score of 10 (worst influence of the problem considered). Single scores and sum scores will be analysed. |
| Secondary | Tinnitus Severity Scale (one week version): Change from Baseline | Baseline to week 5, 17, 23, and 29 | See outcome measure #2. |
| Secondary | Attention and Performance Self-Assessment (ASPA) Questionnaire: Change from Baseline | Baseline to week 5, 17, 23, and 29 | The ASPA consists of 30 simple statements for which the patient can determine how regular this happens to him/her. The response options for each statement are "never", "seldom", "sometimes", "often" and "always". |
| Secondary | Quality of Life Questionnaire (SF-36™ Health Survey): Change from Baseline | Baseline to week 17 and 29 | The SF-36 is a multipurpose health survey with 36 questions. It is a generic measure commonly used in general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments. |
| Secondary | Hospital Anxiety and Depression Scale (HADS): Change from Baseline | Baseline to week 17 and 29 | The HADS is a self-assessment scale with 14 items which has been developed for non psychiatrists to detect states of depression and anxiety in a hospital outpatient population. Every item is rated with a scale (3= very often indeed; 2= quite often; 1= not very often; 0= not at all). Lower total scores indicate "normal", higher total scores "abnormal". |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00955799
GET https://conductscience.org/api/trials/v1/NCT00955799/registered