Trial Outcomes & Findings for Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Sudden Sensorineural Hearing Loss (NCT NCT02414152)

NCT ID: NCT02414152

Last Updated: 2017-03-13

Results Overview

Patients who had a response to anakinra based on hearing threshold improvement compared to their pre-treatment threshold.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: 120 days
• Results posted on: 2017-03-13

Participant Flow

Participant milestones

Measure	Anakinra 100mg of Anakinra administered as a daily subcutaneous injection anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Anakinra 100mg of Anakinra administered as a daily subcutaneous injection anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response
Overall Study Withdrawal by Subject	1
Overall Study Lack of Efficacy	1

Baseline Characteristics

Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Sudden Sensorineural Hearing Loss

Baseline characteristics by cohort

Measure	Anakinra n=2 Participants 100mg of Anakinra administered as a daily subcutaneous injection anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 120 days

Population: Zero subjects were analyzed because both enrolled subjects were withdrawn after receiving 56 days of anakinra because no hearing improvement was noted. They did not complete the entire study.

Patients who had a response to anakinra based on hearing threshold improvement compared to their pre-treatment threshold.

Outcome measures

Outcome data not reported

Adverse Events

Anakinra

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Anakinra n=2 participants at risk 100mg of Anakinra administered as a daily subcutaneous injection anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response
Skin and subcutaneous tissue disorders injection site reaction	100.0% 2/2
Nervous system disorders headache	50.0% 1/2
General disorders fatigue	50.0% 1/2
Vascular disorders leg edema	50.0% 1/2
Skin and subcutaneous tissue disorders dermatitis	50.0% 1/2
Ear and labyrinth disorders increased tinnitus	50.0% 1/2

Additional Information

Dr. Andrea Vambutas

Northwell Health

Phone: 718-470-7550

Email: avambuta@northwell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place