E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The effect of pregabalin on the success to reduce the interference by tinnitus by an extinction training is tested in chronic tinnitus sufferers. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- to test a training program for tinnitus patients that provides an auditory signal that induces residual inhibition (RI), trains the extension of residual inhibition by optimizing the length and duration of RI, and is designed to obtain extinction of the tinnitus percept and negative emotional responses,
- to test the additive effects of the calcium channel blocker pregabalin vs. placebo on the training effects,
- to assess effects of the training on habituation of the N100 of the electroencephalogram as well as the skin conductance response to tinnitus-like and control tones in addition to effects on tinnitus severity and interference and RI control
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E.2.2 | Secondary objectives of the trial |
- the development of a procedure to optimally tune the individually most effective auditory signal with regard to maximal residual inhibition within this training program,
- to implement this procedure into a computer program easy to handle for patients
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Twenty-eight patients with chronic (> 0.5 years) constant tinnitus participate in the study with two subgroups of 14 patients matched by age and gender. |
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E.4 | Principal exclusion criteria |
severe hearing loss, head or ear injury or operation, other outer or inner ear diseases, physical cause of tinnitus, major mental disorder according to DSM-IV-TR, centrally acting medication, neuropathic pain, epilepsy, pregnancy, galactose intolerance, lapp lactase deficiency, glucose galactose malabsorbtion, renal and nephrological insufficiency. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The preparatio for the training study presumably starts in June 2006. After 3 months of preparation, and after individuals give informed consent, psychological and psychophysical assessments are performed. This group design is a multiple baseline design in which small groups of patients successively enter treatment 2, 4, 6, or 8 weeks after the diagnostic assessment thus providing variable waiting periods that will be used to assess tinnitus parameters. The medication will be given for 8 weeks in parallel to the auditory training procedure. We expect to collect data until 04-2006, data analyses will be approximately finished in the end of 5-2007. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |