Clinical Trials Register

Summary
EudraCT Number:	2015-002602-36
Sponsor's Protocol Code Number:	KKSH-127
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-03-08
Trial 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

Germany - BfArM

A.2

EudraCT number

2015-002602-36

A.3

Full title of the trial

Efficacy and safety of high dose glucocorticosteroid treatment for idiopathic sudden sensorineural hearing loss (HODOKORT)

Studie zur Wirksamkeit und Sicherheit der HOchDOsis-GlukoKORTikoid-Therapie beim akuten, idiopathischen, sensorineuralen Hörverlust (HODOKORT)

A.3.1

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

Efficacy and safety of high dose glucocorticosteroid treatment for sudden hearing loss (HODOKORT)

Studie zur Wirksamkeit und Sicherheit der HOchDOsis-GlukoKORTikoid-Therapie beim Hörsturz (HODOKORT)

A.3.2

Name or abbreviated title of the trial where available

HODOKORT

A.4.1

Sponsor's protocol code number

KKSH-127

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	Martin-Luther-Universität Halle-Wittenberg
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Federal Ministry of Education and Research
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Coordinating Centre for Clinical Trials University of Halle (KKSH)
B.5.2	Functional name of contact point	KKSH
B.5.3	Address:
B.5.3.1	Street Address	06120
B.5.3.2	Town/ city	Halle (Saale)
B.5.3.4	Country	Germany
B.5.4	Telephone number	++49+3455574920
B.5.5	Fax number	++49+3455575210
B.5.6	E-mail	hoersturz-studie@kks-halle.de

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	Yes
D.2.1.1.1	Trade name	Prednisolut® 250 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Mibe GmbH Arzneimittel
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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.IMP: 2
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	Yes
D.2.1.1.1	Trade name	Dexamethason 8 mg JENAPHARM®
D.2.1.1.2	Name of the Marketing Authorisation holder	mibe GmbH Arzneimittel
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	Prednisolon 20 mg JENAPHARM® Tabletten
D.2.1.1.2	Name of the Marketing Authorisation holder	mibe GmbH Arzneimittel
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Powder and solvent for solution for injection
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Idiopathic sudden sensorineural hearing loss

Akuter, idiopathischer, sensorineuraler Hörverlust

E.1.1.1

Medical condition in easily understood language

Hearing loss

Hörsturz

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

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the efficacy (hearing threshold improvement) of high dose systemic glucocorticosteroids (“steroids”) versus standard of care (standard dose systemic steroids) for the treatment of unilateral idiopathic sudden sensorineural hearing loss, when given as a primary therapy

Bestimmung der Wirksamkeit einer intravenösen oder oralen primären, systemischen Hochdosis-Glukokortikoid-Therapie im Vergleich zur Standarddosis-Therapie in der Behandlung des einseitigen, akuten, idiopathischen Hörverlustes („Hörsturz“)

E.2.2

Secondary objectives of the trial

To assess the safety (hearing threshold improvement) of high dose systemic glucocorticosteroids (“steroids”) versus standard of care (standard dose systemic steroids) for the treatment of unilateral idiopathic sudden sensorineural hearing loss, when given as a primary therapy

Bestimmung der Sicherheit einer intravenösen oder oralen primären, systemischen Hochdosis-Glukokortikoid-Therapie im Vergleich zur Standarddosis-Therapie in der Behandlung des einseitigen, akuten, idiopathischen Hörverlustes („Hörsturz“)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-female and male adults (18-80 years)
-unilateral sensorineural hearing loss
-sudden onset of hearing loss (occurring within 24 hours)
-unknown etiology (no other ear or CNS disease)
-change in hearing threshold due to ISSHL of 30 dB or higher (as compared to a pre-event audiogram, the audiogram of the unaffected ear, or the ISO) for the 3 most affected contiguous frequencies in the affected ear but not less then 50 dB absolute threshold as average of the 3 most affected contiguous frequencies between 0,25 und 8 kHz < 50 dB HL
-enrolment and treatment within 7 days from onset

-weibliche und männliche Erwachsene (18-80 Jahre)
-einseitiger sensorineuraler Hörverlust
-plötzliches Auftreten des Hörverlustes (innerhalb von 24 h)
-unklare Ursache (keine andere Ohr- oder ZNS-Erkrankung)
-Verschlechterung der Luftleitungs-Hörschwelle um 30 dB HL oder mehr für die 3 am meisten betroffenen benachbarten Frequenzen des betroffenen Ohres (bezogen auf das Audiogram vor dem Auftreten oder des gesunden Ohres oder Normal-Audiogramm nach DIN-ISO 7029) und absolute Hörschwelle von 50 dB HL oder mehr als Mittelwert der drei am meisten betroffenen benachbarten Frequenzen im Bereich zwischen 0,25 und 8 kHz
-Einschluss und Behandlungsbeginn innerhalb von 7 Tagen nach Auftreten

E.4

Principal exclusion criteria

-recurrent ISSHL at the affected side (< 12 months)
-known other otologic cause of ISSHL (e.g.: middle ear disease; vestibular schwannoma; known fluctuating hearing loss; Meniere’s disease)
-absolute hearing threshold as average of the 3 most affected contiguous frequencies between 0,25 und 8 kHz < 50 dB HL
-certain systemic diseases (treatment for or chronically active infection such as HIV, hepatitis C or B, tuberculosis, hard to balance diabetes mellitus, ongoing immunosuppressive treatment for rheumatic or chronic inflammatory disease, unstable atherosclerotic disease, heart failure >NYHA II, suicidality, severe osteoporosis, active peptic ulcer, uncontrolled (syst. >180 mmHg or diast. >100 mmHg) arterial hypertension)
-treated mental disorders or after surgical interventions in the last 6 weeks: inclusion only after critical evaluation by the investigator
-pre-treatment of ISSHL with glucocorticosteroids or hyperbaric oxygen
-conductive deafness (air-bone gap 4PTA0,5-4kHz >10 dB)
-pregnancy or lactation

-wiederholter Hörsturz auf betroffener Seite (< 12 Monate)
-bekannte systemische oder otologische (z.B. Mittelohrer-krankung, Vestibularisschwannom, fluktuierender Hörverlust, Morbus Menière) Ursache des akuten Hörverlustes
-durchschnittlicher Hörverlust (drei am meisten betroffene benachbarte Frequenzen im Bereich zwischen 0,25 und 8 kHz) < 50 dB HL
-bestimmte systemische Erkrankungen (Behandlung oder chronische Infektion mit HIV, Hepatitis C oder B, Tuberkulose, schwer einstellbarer Diabetes mellitus, laufende immunsupprimierende Behandlung rheumatischer oder chronisch-entzündlicher Erkrankungen, instabile atherosklerotische Erkrankung, Herzinsuffizienz >NYHA II, Suizidalität, schwere Osteoporose, Ulkus gastrici sive duodeni, unkontrollierter Bluthochdruck (syst. >180 mmHg oder diast. >100 mmHg)
-bei behandelten psychischen Störungen oder Erkrankungen oder nach chirurgischen Eingriffen in den letzten 6 Wochen: Einschluss nur nach kritischer Bewertung durch Prüfarzt
-Vorbehandlung (spezifisch auf den Hörsturz gerichtete Vorbehandlung mit Glukokortikosteroiden oder hyperbarem Sauerstoff)
-Schallleitungsschwerhörigkeit (Air-bone gap 4PTA0,5-4kHz >10 dB)
-Schwangerschaft/ Stillzeit

E.5 End points

E.5.1

Primary end point(s)

Average change in hearing thresholds (pure-tone average of the 3 most affected contiguous frequencies)

Durchschnittliche Änderung in der Hörschwelle (Reintonhörschwelle der 3 am stärksten betroffenen benachbarten Frequenzen)

E.5.1.1

Timepoint(s) of evaluation of this end point

30 days after enrolment

30 Tage nach Einschluss

E.5.2

Secondary end point(s)

-average change in pure tone hearing level (3PTA0,5-2kHz [Fletcher-Typ] und 4PTA0,5-4kHz) 30 days after enrolment
-percentage of patients with complete, partial or no improvement of hearing
-average change in percentage of ear-specific masked monosyllabic words understood correctly at 65 and 80 dB SPL
-patient self evaluation, quality of life and communication competence (patient questionnaires)
-percentage of patients needing a hearing aid/ cochlear implant
-percentage of patients with new or worsened arterial hypertension at day 5 (office blood pressure >140 mmHg syst. or >90 mmHg diast. or both)
-percentage of patients with altered glucose tolerance at day 5 (to be detected by HOMA-IR)
-need for rescue therapy
-occurrence and extent of tinnitus one and six month after enrolment

-Durchschnittliche Änderung in der Reintonhörschwelle (3PTA0,5-2kHz [Fletcher-Typ] und 4PTA0,5-4kHz) 30 Tage nach Einschluss
-Anteil der Patienten mit kompletter, partieller oder keiner Verbesserung des Hörvermögens
-durchschnittliche Veränderung des Sprachverstehens mit dem betroffenen Ohr (Prozent korrekt verstandene Freiburger Einsilber bei 65 und 80 dB SPL)
-Durchschnittliche Änderung in der Patientenselbsteinschätzung des allgemeinen Gesundheitszustandes, Lebensqualität und Kommunikationskompetenz (Fragebögen)
-Anteil der Patienten, die ein Hörgerät/ Cochlea-Implantat benötigen
-Patienten mit erworbenem oder verstärktem Bluthochdruck an Tag 5 (während der Visite >140 mmHg systolisch oder >90 mmHg diastolisch oder beides)
-Anteil der Patienten mit veränderter Glukosetoleranz an Tag 5 (HOMA-IR)
-Durchführung einer „Rettungstherapie“
-Vorhandensein und Ausmaß des Tinnitus 30 Tage und 6 Monate nach Einschluss

E.5.2.1

Timepoint(s) of evaluation of this end point

30 days and 180 days after enrolment

30 und 180 Tage nach Einschluss

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

Yes

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)

Yes

E.8.2.2

Placebo

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

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

E.8.7

Trial has a data monitoring committee

Yes

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

end of the trial is defined as the time point the data bank is locked. Justification for this definition: study-specific documentation has to be completed until this time-point

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

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:

156

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

156

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

312

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)

not different from the expected normal treatment of that condition, see protocol

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-06-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-06-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-05-20

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