SERORL Effect of aspirin and folic acid for sudden sensorineural hearing loss

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Otorhinolaryngologic Diseases [C09]

Decision date (initial)

2025-10-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

DGOS et mécène

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To determine if an early treatment with Aspirin 100mg/day and Folic Acid 5 mg/day induces a significant improvement of the PTA (mean of the change of the hearing thresholds for the 3 most affected contiguous frequencies) at D15 in patients presenting with SSNHL.

Secondary objectives 4

1. - To determine if an early treatment with Aspirin 100mg/day and Folic Acid 5 mg/day added induces a significant improvement of the maximal speech intelligibility (word recognition) score at D15, M3 and M6 in patients presenting with SSNHL.
2. - To determine if an early treatment with Aspirin 100mg/day and Folic Acid 5 mg/day added induces a significant improvement of the mean PTA (mean of the change of the hearing thresholds for the 3 most affected contiguous frequencies) at M3 and M6
3. - To determine an improvement of the auditory quality of life THI and DHI at D15, M3, M6
4. - To determine if an early treatment with aspirin 100mg/day and Folic acid 5mg/day added induces a significant improvement of the vestibular function at D15, M3, M6: • Normalisation of the VNS • VHIT gain

Conditions and MedDRA coding

Patients presenting to ENT emergencies with a unilateral sudden sensorineural hearing loss (SSNHL). SSNHL is defined according to the American ENT society guidelines criteria as a subset of SSNHL that is sensorineural in nature, occurs within a 72 hour window, and consists of a decrease in hearing of ≥30 decibels affecting at least 3 consecutive frequencies: 1. A history of an idiopathic and unilateral sudden decrease in hearing > 72 hours and <15 days. 2. A unilateral sensorineural hearing loss demonstrable on a pure‐tone audiogram at the time of entry into the trial. 3. No other neurological signs except the eight cranial nerve defect; no other types of hearing loss as conductive forms of hearing impairment. 4. No history of fluctuating sensorineural hearing loss or otologic disease.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. - Age > 18 and < 80 years
2. - Unilateral SSNHL defined as a sudden hearing loss of 30dB or greater at least three contiguous audiometric frequencies (between 125hz and 8000Hz) occurring within a 72 hr period and for less than 15 days.
3. - Individuals affiliated to a social security regimen
4. - Individuals able to participate and to follow up during the study period

Exclusion criteria 10

1. Contra-indications to Aspirin,
2. - Contra-indications to oral corticosteroid therapy,
3. - Contra-indications to dexamethasone
4. - Allergy to vitamin B9
5. - Evident cause of acute SSNHL including tumor of the ponto-cerebellous angle, infectious labyrinthitis, mechanical and acoustic trauma, malformation of the inner ear, neurological disorder
6. - Patient already including in another clinical trial
7. - Person under legal protection (under guardianship or curatorship)
8. -Patients taking serotonin reuptake inhibitors
9. - Patients already taking aspirin or other anticoagulant or antiplatelet agent
10. - Pregnant or breastfeeding women

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. - Mean PTA (mean of the change of the hearing thresholds for the 3 most affected contiguous frequencies) at D15 as defined by the AAO-HNS: complete recovery with return to less than 10 dB HL of the unaffected ear, no recovery: anything below 10 dB. Partial recovery is between the two extremes.

Secondary endpoints 4

1. - Maximal speech intelligibility (word recognition) score at D15, M3 and M6.
2. - Mean of pure tones defined as the mean PTA (mean of the change of the hearing thresholds for the 3 most affected contiguous frequencies) at M3 and M6 as defined by the AAO-HNS: complete recovery with return to less than 10 dB HL of the unaffected ear,no recovery: anything below 10 dB. Partial recovery is between the two extremes.
3. - Quality of life will be evaluated with THI and DHI questionnaire at D15, M3 and M6.
4. - Vestibular function assessed at D15, M3 and M6 with: • presence or absence of a spontaneous and positional nystagmus • mean gains of the vestibulo-ocular reflex measured by the vHIT

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Investigateur coordonnateur

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Investigateur coordonnateur

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications