Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

February 15, 2019

Primary Completion Date

November 4, 2021

Study Completion Date

January 12, 2022

Conditions
Severe Sudden Sensorineural Hearing Loss
Interventions
DRUG

SENS-401

29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks

OTHER

Placebo Oral Tablet

placebo, oral route, by mouth, twice a day, during 4 weeks

DRUG

SENS-401

43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks

Trial Locations (26)

1606

MI Minisrty of Interior Affair Sofia Clinic of Otorhinolaryngology, Sofia

Military Medical Academy; Clinic of Otorhynolaryngology, Sofia

8000

Multiprofile Hospital for Active Treatment Burgas AD Department of Otorhynolaryngology, Burgas

11000

Clinical Hospital Center Dr Dragisa Misovic-Dedinje, Belgrade

13003

Hôpital Européen, Marseille

21000

Clinical Center of Vojvodina, Novi Sad

31059

Hôpital Pierre Paul Riquet- CHU Purpan, Toulouse

34722

Istanbul Medeniyet University Goztepe Training and Research Hospital, Department of Ear,Nose,Throat, Istanbul

38039

Erciyes University Medical Faculty Department of Ear Nose Throat, Melikgazi

38100

Hillel Yaffe Medical Center, Hadera

57404

43ème Antenne Médicale de Sarrebourg, Sarrebourg

72076

Universitätsklinikum Tübingen Klinik für Hals-, Nasen- u. Ohrenheilkunde Plastische Operationen, Tübingen

75475

Hôpital Lariboisière, Paris

79400

109ème Antenne Médicale de Saint-Maixent l'école, Saint-Maixent-l'École

83000

Hôpital d'Instruction des armées SAINTE ANNE, Toulon

92140

Hôpital d'Instruction des Armées Percy, Clamart

3109601

Rambam Medical Center Health Care Campus, Haifa

3436212

Lady Davis Carmel Medical Center, Haifa

4341492

Rabin Medical Center, Otolaryngology, Head and Neck Surgery Gour Shasha Tower Building, floor#7, Petah Tikva

G1V 4G2

CHU de Quebec - Centre Hospitalier de l'Universite Laval, Québec

S7K 1N4

Wall Street ENT Clinic, Saskatoon

Unknown

Fakultni nemocnice u sv. Anny v Brne-Klinika otorinolaryngologie a chirurgie hlavy a krku, Brno

Fakultni nemocnice Hradec Kralove -Klinika otorinolaryngologie a chirurgie hlavy a krku, Hradec Králové

03101

MUDr. Igor Kažmér, s.r.o., Liptovský Mikuláš

08001

Fakultna nemocnica s poliklinikou J. A. Reimana Presov, Oddelenie otorinolaryngologie a chirurgie hlavy a krku, Prešov

S10 2JF

The Royal Hallamshire Hospital, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sensorion

INDUSTRY

NCT03603314 - Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss | Biotech Hunter | Biotech Hunter