A Phase II multicenter, placebo-controlled, proof-of-concept study evaluating the safety, and efficacy of intratympanic STR001 thermogel to preserve residual hearing in adults undergoing cochlear implant surgery

• Register: EUCTR
• Last refreshed on: 7 January 2019
• Main ID: EUCTR2015-002672-25-DE
• Date of registration: 21/09/2015
• Prospective Registration: Yes
• Primary sponsor: Strekin AG
• Public title: A Phase II multicenter, placebo-controlled, proof-of-concept study evaluating the safety, and efficacy of intratympanic STR001 thermogel to preserve residual hearing in adults undergoing cochlear implant surgery
• Scientific title: A Phase II multicenter, placebo-controlled, proof-of-concept study evaluating the safety, and efficacy of intratympanic STR001 thermogel to preserve residual hearing in adults undergoing cochlear implant surgery
• Date of first enrolment: 18/11/2015
• Target sample size: 110
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002672-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany, Spain

Contacts

• Name: CEO
• Affiliation: Strekin AG

• Name: CEO
• Affiliation: Strekin AG

Key inclusion & exclusion criteria

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

Prevention of Hearing Loss after Cochlear Implant Surgery

Intervention(s)

Product Name: STR001 thermogel
Product Code: STR001
Pharmaceutical Form: Gel for injection
INN or Proposed INN: not available
Current Sponsor code: STR001
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 1.2-
Pharmaceutical form of the placebo: Gel for injection
Route of administration of the placebo: Intratympanic use (Noncurrent)

Primary Outcome(s)

Secondary Objective: 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

Main Objective: 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

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

Timepoint(s) of evaluation of this end point: 6 weeks after CI surgery

Secondary Outcome(s)

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.

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)

Secondary ID(s)

STR001-201

Source(s) of Monetary Support

Strekin AG