E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of Hearing Loss after Cochlear Implant Surgery |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of Hearing Loss after Cochlear Implant Surgery |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety and tolerability of STR001 thermogel in patients receiving cochlear implants
To assess the efficacy of STR001 thermogel in preserving hearing 6 weeks after cochlear implant surgery as determined by average Pure Tone Audiometry (aPTA) values
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E.2.2 | Secondary objectives of the trial |
To evaluate secondary efficacy parameters of hearing on average Bone Conduction Threshold Audiometry (aBCTA) and individual frequencies by BCTA and PTA.
To evaluate the systemic exposure of STR001 after STR001 thermogel administration
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Males or females aged between ≥18 years and ≤ 80 years
2. Patients with a diagnosis of moderate to severe hearing loss with ≤ 80 dB by average Pure Tone Audiometry measured at the frequencies of 125, 250, 500 and 750Hz, eligible for cochlear implant surgery (average up to 82.5 will be rounded down to 80 i.e. will be considered eligible)
3. Patients must be willing and capable to perform all study procedures
4. Patients have understood the patient Information documents and have provided informed consent
5. Females must have a negative Serum pregnancy test or must be post-menopausal |
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E.4 | Principal exclusion criteria |
1. Malformation or cochlear ossification
2. Developmental disabilities or psychiatric diseases such as severe depression
3. History of Meniere’s disease
4. Acute or chronic middle ear inflammatory disease
5. Use of thiazolidinedione (e.g. pioglitazone, rosiglitazone) in the last 6 months prior to baseline
6. Chronic (i.e. at least 3 continuous months) oral steroids in the last 6 months prior to baseline
7. Daily nasal/pulmonary steroid in the last month prior to baseline
8. Fibrates (e.g. gemfibrozil, fenofibrate) in the last 6 months prior to baseline
9. Patients with known hypersensitivity to STR001 or any formulation component
10. Initiation of treatment with lipophilic statins (e.g. atorvastatin, pitavastatin, lovastatin, fluvastatin or simvastatin) in the last month prior to inclusion in the study. Patients on stable doses of lipophilic statins should continue therapy during the study.
11. Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past month prior to baseline
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: Average Pure Tone Audiometry Treshold (aPTA) at 125, 250, 500 and 750 Hz of implanted ear at Week 6.
Safety: The incidence and severity of adverse events, serious adverse events, deaths, as well as drug and study discontinuations; The incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results; ECGs; Physical examination; Vital signs
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Efficacy (key): BCTA of the implanted ear as the average of the following frequencies: 250, 500 and 750 Hz at Week 6.
Efficacy (other):
Pure Tone Audiometry will also be assessed at each individual frequency at 125, 250, 500 and 750 Hz at Week 6.
BCTA will also be assessed at each individual frequency at 250, 500 and 750 Hz at Week 6.
BCTA will also be assessed at each frequency: 250, 500 and 750 Hz at Week 6.
Pharmacokinetics: STR001 and its main metobolites (M-III and M-IV) Plasma concentrations. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Efficay: 6 weeks after CI surgery
Pharmacokinetics: At baseline, prior to surgery and after the surgery (4 samples/Patient)
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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 | No |
E.7.1.3.1 | Other trial type description | |
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 | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |