Table 3 Table of Assessments

From: A phase I/IIa safety and efficacy trial of intratympanic gamma-secretase inhibitor as a regenerative drug treatment for sensorineural hearing loss

 

Screening

Treatment period

Follow up period

Optional visits

Activity Visit window

Day 1

Day 8

Day 15

Week 6

Week 12

Month 6

Month 12

Baseline

Dose 1

Dose 2

Dose 3

Informed Consent

X

        

Review of in/exclusion criteria

X

X

       

Medical history and demography

X

        

Vital signs

X

X

X

X

X

X

X

  

Physical examination

X

X

 

X

X

X

X

X

X

12-lead ECG

X

 

X

X

X

X

X

  

Laboratory assessments

X

 

X

X

X

X

X

  

Clinical balance assessment

  

X

X

X

X

 

X

X

Full balance assessment

X

     

X

  

Facial nerve function

X

 

X

X

X

X

X

X

X

Taste assessment

  

X

X

X

X

X

X

X

Otomicroscopy

X

X

 

X

X

X

X

X

X

PTA

X

 

X

X

X

X

X

X

X

Speech Audiometry

X

    

X

X

X

X

DPOAE, SNR and absolute

 

X

   

X

X

X

X

Cochlear dead region assessment

 

X

   

X

X

  

ART

 

X

    

X

  

Tympanometry

X

     

X

X

X

Tinnitus assessment

X

X

X

X

X

X

X

X

X

QoL (HHIA/E questionnaire)

X

    

X

X

X

X

Hearing Aid questionnaire

X

      

X

X

Drug dosing - Injection

  

X

X

X

    

Pregnancy testing

X

X

 

X

X

X

X

  

Concomitant medication

X

X

X

X

X

X

X

X

X

Adverse Events

X

X

X

X

X

X

X

X

X

Back to article page