Clinical Trials Register

Summary
EudraCT Number:	2015-002672-25
Sponsor's Protocol Code Number:	STR001-201
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-09-10
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-002672-25

A.3

Full title of the trial

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

Studio proof-of-concept di Fase II, multicentrico, verso placebo, per la valutazione della sicurezza e dell’efficacia di thermogel STR001 intratimpanico nella conservazione del residuo uditivo in pazienti adulti sottoposti a impianto cocleare

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.3.2

Name or abbreviated title of the trial where available

STR001-201

A.4.1

Sponsor's protocol code number

STR001-201

A.5.4

Other Identifiers

Name:

STR001-201

Number:

STR001-201

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	STREKIN AG
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	STREKIN AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ACCELOVANCE EUROPE s.r.l.
B.5.2	Functional name of contact point	Dipartimento Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	via Alberto Falck, 15
B.5.3.2	Town/ city	Sesto San Giovanni (MI)
B.5.3.3	Post code	20099
B.5.3.4	Country	Italy
B.5.4	Telephone number	0039 02 24134 261
B.5.5	Fax number	0039 02 24862961
B.5.6	E-mail	accelovance_europe_starttup@pec.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Pioglitazone idrocloridrato
D.3.2	Product code	STR001
D.3.4	Pharmaceutical form	Ear gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intratympanic use (Noncurrent)
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Ear gel
D.8.4	Route of administration of the placebo	Intratympanic use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Prevention of Hearing Loss after Cochlear implant surgery

Prevenzione della perdita dell’udito dopo impianto cocleare

E.1.1.1

Medical condition in easily understood language

Prevention of Hearing Loss after Cochlear implant surgery

Prevenzione della perdita dell’udito dopo impianto cocleare

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLGT
E.1.2	Classification code	10019243
E.1.2	Term	Hearing disorders
E.1.2	System Organ Class	10013993 - Ear and labyrinth disorders

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

Valutare la sicurezza e la tollerabilità del thermogel STR001 nei pazienti riceventi impianto cocleare.

Determinare l’efficacia del Thermogel STR001 nella conservazione dell’udito 6 settimane dopo impianto cocleare, determinata in base ai valori medi registrati con audiometria tonale (average Pure Tone Audiometry, aPTA).

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

Valutare i parametri secondari di efficacia dell’udito in base ai valori medi determinati con audiometria liminare per via ossea (average Bone Conduction Threshold Audiometry, aBCTA) e sulle singole frequenze mediante BCTA e PTA.

Valutare l’esposizione sistemica a STR001 dopo somministrazione di Thermogel STR001

E.2.3

Trial contains a sub-study

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

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

1. Uomini e donne di età compresa fra = 18 e = 80 anni

2. Pazienti con diagnosi di ipoacusia da grave a profonda con audiometria tonale media < 80 dB misurata alle frequenze di 125, 250, 500 e 750Hz, eleggibili all’impianto cocleare .

3. I pazienti devono essere in grado di effettuare tutte le procedure di studio e di esprimere la volontà di farlo.

4. I pazienti devono aver compreso il contenuto del documento informativo per il paziente e aver concesso il proprio consenso informato.

5. I soggetti di sesso femminile devono risultare negativi al test serico di gravidanza, oppure essere in post menopausa

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 pioglitazone 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

12. Women who are breast feeding, pregnant, or plan to get pregnant during the trial

13. Women of childbearing potential unwilling/unable to
practice contraception

14. Participation in other clinical trials in the last month prior to baseline

15. Patients who are institutionalized upon authorities or legal request

16. Patients who are vulnerable (e.g. employees or relatives of sponsor, investigator or investigational site staff or patients in emergency situations)

17. Patients where oral administration of pioglitazone is contraindicated (i.e. cardiac failure or history of cardiac failure (NYHA stages I to IV), hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic haematuria)

1. Malformazione od ossificazione cocleare

2. Disabilità dello sviluppo o malattie psichiatriche quali depressione grave

3. Storia di malattia di Meniere

4. Malattia infiammatoria acuta o cronica dell’orecchio medio

5. Uso di tiazolinedioni (es. pioglitazone, rosiglitazone) nei 6 mesi precedenti il basale

6. Uso cronico di steroidi orali (vale a dire almeno 3 mesi continuativi) nei 6 mesi precedenti il basale

7. Uso quotidiano di steroidi per via nasale/polmonare nel mese precedente il basale

8. Uso di fibrati (es. gemfibrozil, fenofibrato) nei 6 mesi precedenti il basale

9. Pazienti con ipersensibilità nota al pioglitazone o a qualsiasi componente della formulazione

10. Avvio di terapia con statine lipofile (es. atorvastatina, pitavastatina, lovastatina, fluvastatina o simvastatina) nel mese precedente l’inclusione nello studio. I pazienti in dosaggio stabile di statine lipofile devono proseguire la terapia durante lo studio.

11. Qualsiasi terapia farmacologica (in atto o effettuata nel mese precedente il basale) dell’ipoacusia neurosensoriale.

12. Donne in allattamento, incinte, o che stanno pianificando una gravidanza durante il periodo di svolgimento del trial

13. Donne potenzialmente in grado di avere figli che non intendono o non possono praticare la contraccezione

14. Partecipazione ad altre sperimentazioni cliniche nel mese precedente il basale

15. Pazienti ricoverati in strutture psichiatriche in seguito a provvedimento giudiziario o legale

16. Pazienti vulnerabili (p.es. dipendenti o parenti dello sponsor, dello sperimentatore o del personale del sito di sperimentazione oppure pazienti in situazioni di emergenza)

17. Pazienti per i quali è controindicata la somministrazione di pioglitazone orale [per esempio con insufficienza cardiaca o storia di insufficienza cardiaca (classificazione NYHA da I a IV), insufficienza epatica, cheto acidosi diabetica, con cancro o storia di cancro alla vescica, ematuria macroscopica non indagata ]

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: Incidence and severity of adverse events, serious adverse events, deaths, as well as drug and study discontinuations. Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results; ECGs; Physical Examination; Vital signs.

Efficacia: Soglia media dell’audiometria tonale (Average Pure Tone Audiometry Treshold (aPTA) a 125, 250, 500 e 750 Hz dell’orecchio impiantato alla settimana 6.

Sicurezza: Incidenza degli eventi avversi (anche per severità), eventi avversi seri, morte, interruzioni del farmaco e dello studio. Parametri di laboratorio (biochimica, ematologia, analisi delle urine)
Elettrocardiogramma, Esame fisico, Segni vitali.

E.5.1.1

Timepoint(s) of evaluation of this end point

6 weeks after CI Surgery

6 settimane dopo impianto cocleare

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.

Pharmacokinetics: Pioglitazone and its main metabolites (M-III and M-IV) plasma concentrations.

Efficacia (principale): La BCTA media verrà valutata alla settimana 6 sull’orecchio impiantato, determinata come la media dei valori alle seguenti frequenze; 250, 500 e 750 Hz.

Efficacia (altro): L’audiometria tonale verrà valutata, alla settimana 6, anche per ciascuna singola frequenza a 125, 250, 500 e 750 Hz.

La BCTA verrà valutata, sempre alla settimana 6, anche per ciascuna singola frequenza a 250, 500 e 750 Hz.

Farmacocinetica: concentrazione nel plasla di Pioglitazone e dei suoi principali metaboliti (M-III e M-IV)

E.5.2.1

Timepoint(s) of evaluation of this end point

Efficacy: 6 weeks after CI surgery

Pharmacokinetics: at baseline, prior to surgery and after the surgery (4 samples/patient).

Efficacia: 6 settimane dopo impianto cocleare

Farmacocinetica: al baseline, prima dell'impianto e dopo l'impianto (4 campioni/paziente)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

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

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

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

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

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

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

110

F.4.2.2

In the whole clinical trial

110

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patients will receive intratympanic administration prior to, and at the time of the surgery and hearing preservation will be assessed at 6 weeks.Since the hearing loss occurs shortly after the surgery, the benefit should be demonstrated after 6 weeks and no further treatment with STR001 in anticipated. After 6 weeks, the cochlear implant will be activated and the surgeon will continue to ensure medical care of the patients after cochlear implant activation and rehabilitation.

I pazienti riceveranno la somministrazione intratimpanica prima e durante l'impianto. La conservazione dell'udito verrà controllata dopo 6 settimane dall'impianto. Qualora accadesse una perdita di udito immediatamente dopo l'intervento il beneficio potrà essere dimostrato dopo 6 settimane e non è previsto nessun ulteriore trattamento con STR001. Dopo 6 settimane l'impianto cocleare sarà attivato ed il chirurgo continuerà ad assicurare le cure mediche del caso.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-01-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-10-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-11-15

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