Trial Outcomes & Findings for Inhibitor Masking Device & Sodium Channel, Voltage Gated, Type IX Alpha Subunit (SCN9) Gene Expression (NCT NCT01412918)

NCT ID: NCT01412918

Last Updated: 2016-02-29

Results Overview

Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: Single visit (day 1), assessed the day of visit
• Results posted on: 2016-02-29

Participant Flow

Participant milestones

Measure	Tinnitus Individual with tinnitus. The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device	No Tinnitus Individuals without tinnitus.
Overall Study STARTED	20	1
Overall Study COMPLETED	20	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inhibitor Masking Device & Sodium Channel, Voltage Gated, Type IX Alpha Subunit (SCN9) Gene Expression

Baseline characteristics by cohort

Measure	Tinnitus n=20 Participants Individual with tinnitus. The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device	No Tinnitus n=1 Participants Individuals without tinnitus.	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	0 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Single visit (day 1), assessed the day of visit

Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device.

Outcome measures

Measure	Tinnitus n=13 Participants Tinnitus. genetic sample collection (no intervention)	No Tinnitus Individuals without tinnitus.
Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception	76 percentage of participants	—

SECONDARY outcome

Timeframe: Single visit (day 1), evaluated at the time of the genetic collection.

Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression.

Outcome measures

Measure	Tinnitus n=18 Participants Tinnitus. genetic sample collection (no intervention)	No Tinnitus n=1 Participants Individuals without tinnitus.
Percentage of Participants Which Showed Presence of SCN9 Gene Expression.	0 % of participants with gene expression	0 % of participants with gene expression

Adverse Events

Tinnitus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Tinnitus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Friedland

Medical College of Wisconsion

Phone: 414-805-

Email: dfriedland@mcw.edu

Results disclosure agreements

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