Safety and Efficacy of STR001-IT and STR001-ER in Patients With SSHL

A Phase III Multicenter, Double-blind, Placebo-controlled, Study Evaluating the Safety, and Efficacy of STR001 Treatment in Adults With Sudden Sensorineural Hearing Loss

a multicenter, double-blind, placebo-controlled study in patients with Sudden Sensorineural Hearing Loss (SSHL). Patients will be treated with STR001 thermogel (STR001-IT) / STR001 tablets (STR001-ER) and corresponding Placebo on top of standard of care.

Study Overview

• Status: Completed
• Conditions: Acute Hearing Loss
• Intervention / Treatment: Drug: STR001-IT and STR001-ER

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Hradec Kralove, Czechia
    • Fakultni nemocnice Hradec Kralove
• Germany
  • Freiburg, Germany, 79106
    • Universitätsklinik Freiburg
• Switzerland
  • Zürich, Switzerland, 8091
    • Universitatsspital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female patients aged ≥ 18
2. Patients with a SSHL within 96 hours of its perception

3. Sudden Sensorineural Hearing Loss including

   1. idiopathic unilateral Sudden Sensorineural Hearing Loss or
   2. acute uni- or bilateral acoustic trauma-induced Sudden Sensorineural Hearing Loss

Exclusion Criteria:

1. Patients with a history of Meniere's Disease
2. Patients with a hearing threshold above 100 dB across at least 6 frequencies
3. Patients with endolymphatic, hydrops or history of fluctuating hearing loss
4. Patients with suspected perilymph fistula, membrane rupture, retrocochlear lesions or a barotrauma
5. Patients with an air-bone gap of ≥ 20 dB in 3 contiguous frequencies at baseline
6. Previous SSHL incident at the same ear
7. Patients with acute or chronic otitis media or otitis externa.
8. Patients with congenital hearing loss
9. Patients with known hypersensitivity to pioglitazone, other thiazolidindiones or any formulation component
10. Use of thiazolidinedione (e.g. pioglitazone, rosiglitazone) in the last 6 months prior to baseline
11. Any use of CYP450 2C8 inducers (e.g. rifampicine)
12. Fibrates (e.g. gemfibrozil, fenofibrate) in the last 6 months prior to baseline
13. 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
14. Women who are breastfeeding, pregnant or plan to get pregnant during the trial duration
15. Women of childbearing potential unwilling or unable to practice effective method of contraception
16. Participation in other clinical trials in the last month prior to baseline

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: STR001-IT/STR001-ER	Drug: STR001-IT and STR001-ER; STR001-IT intrataympanic injection and STR001-ER tablet
Active Comparator: STR001-IT/STR001-ER Placebo	Drug: STR001-IT and STR001-ER; STR001-IT intrataympanic injection and STR001-ER tablet
Placebo Comparator: STR001-IT placebo/STR001- ER placebo	Drug: STR001-IT and STR001-ER; STR001-IT intrataympanic injection and STR001-ER tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute hearing improvement after 12 weeks	Absolute hearing improvement after 12 weeks measured with PTA using the mean value of the 3 most affected contiguous baseline frequencies (dB)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete hearing recovery after 12 weeks	Percentages of patients with complete hearing recovery after 12 weeks measured with PTA using the mean value of the 3 most affected contiguous frequencies at baseline	12 weeks

Collaborators and Investigators

• Sponsor: Strekin AG

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2018
• Primary Completion (Actual): February 6, 2020
• Study Completion (Actual): February 6, 2020

Study Registration Dates

• First Submitted: November 1, 2017
• First Submitted That Met QC Criteria: November 1, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: 2017-000242-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No