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AM-101 in the Treatment of Post-Acute Tinnitus 1 (AMPACT1)

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ClinicalTrials.gov Identifier: NCT01934010
Recruitment Status : Completed
First Posted : September 4, 2013
Results First Posted : March 9, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Tinnitus
Intervention: Drug: AM-101

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 260 subjects were enrolled and 257 subjects were treated in overall 59 active sites in Canada (6), the United States (35), the Czech Republic (7), Israel (2), Turkey (3) and Republic of South Korea (6). Subjects could only participate if they had been previously enrolled and completed the participation in the TACTT2 study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Main Inclusion Criteria:

  • completion of TACTT2 study
  • negative pregnancy test (women of childbearing potential)
  • willing and able to attend the study visits during at least one treatment cycle.

Reporting Groups
  Description
1 Cycle AM-101 Subjects participated in 1 treatment cycle and received one round of 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0-D4)
2 Cycles AM-101 Subjects that participated in 2 treatment cycles of the AMPACT1 study, received 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0 - D4) in cycle 1 and after final follow-up (D84) of cycle 1, they rolled-over to treatment cycle 2 receiving once more 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D84 - D88).
3 Cycles AM-101 Subjects that participated in all 3 treatment cycles of the AMPACT1 study, received 3 x 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days. The subjects could only roll-over if they completed the final follow-up of the previous cycle and were still eligible. In cycle 1 treatment was within D0 - D4. Cycle 2 treatment within D84 - D88. And treatment for cycle 3 within D168-D172. Final follow-up after 3 treatment cycles was FUV9 (D252).

Participant Flow:   Overall Study
    1 Cycle AM-101   2 Cycles AM-101   3 Cycles AM-101
STARTED   114   67   76 
COMPLETED   91   56   74 
NOT COMPLETED   23   11   2 
Adverse Event                1                1                0 
Withdrawal by Subject                15                6                2 
Lost to Follow-up                7                4                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1 Cycle AM-101 Subjects participated in 1 treatment cycle and received one round of 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0-D4)
2 Cycles AM-101 Subjects that participated in 2 treatment cycles of the AMPACT1 study, received 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D0 - D4) in cycle 1 and after final follow-up (D84) of cycle 1, they rolled-over to treatment cycle 2 receiving once more 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days (D84 - D88).
3 Cycles AM-101 Subjects that participated in all 3 treatment cycles of the AMPACT1 study, received 3 x 3 repeated doses of AM-101 gel (0.87 mg/mL) within 5 days. The subjects could only roll-over if they completed the final follow-up of the previous cycle and were still eligible. In cycle 1 treatment was within D0 - D4. Cycle 2 treatment within D84 - D88. And treatment for cycle 3 within D168-D172. Final follow-up after 3 treatment cycles was FUV9 (D252).
Total Total of all reporting groups

Baseline Measures
   1 Cycle AM-101   2 Cycles AM-101   3 Cycles AM-101   Total 
Overall Participants Analyzed 
[Units: Participants]
 114   67   76   257 
Age 
[Units: Participants]
Count of Participants
       
<=18 years   0   0   0   0 
Between 18 and 65 years   106   61   64   231 
>=65 years   8   6   12   26 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.1  (14.1)   44.7  (13.9)   47.6  (15.5)   44.8  (14.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female   25   17   21   63 
Male   89   50   55   194 
Region of Enrollment 
[Units: Participants]
       
United States   71   45   40   156 
Czechia   24   7   22   53 
Canada   4   11   9   24 
Israel   1   1   1   3 
South Korea   11   1   4   16 
Turkey   3   2   0   5 


  Outcome Measures

1.  Primary:   Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction)   [ Time Frame: Day 1 (TV1) to Day 35 (FUV2) of cycle 1 ]

2.  Primary:   Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction)   [ Time Frame: Day 84 (TV4) to Day 119 (FUV5) of cycle 2 ]

3.  Primary:   Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction)   [ Time Frame: Day 168 (TV7) up to Day 203 (FUV8) of cycle 3 ]

4.  Secondary:   Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction)   [ Time Frame: Day 1 (TV1) to Day 84 (FUV3) of cycle 1 ]

5.  Secondary:   Frequency of Subjects With a Deterioration of Hearing Threshold at Day 168 (Air Conduction)   [ Time Frame: Day 84 (TV4) to Day 168 (FUV6) of cycle 2 ]

6.  Secondary:   Frequency of Subjects With a Deterioration of Hearing Threshold at Day 252 (Air Conduction)   [ Time Frame: Day 168 (TV7) to Day 252 (FUV9) of cycle 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Thomas Meyer, CEO
Organization: Auris Medical Inc.
phone: +1 312 396 4150
e-mail: hear@aurismedical.com



Responsible Party: Auris Medical, Inc.
ClinicalTrials.gov Identifier: NCT01934010     History of Changes
Other Study ID Numbers: AM-101-CL-12-03
First Submitted: August 15, 2013
First Posted: September 4, 2013
Results First Submitted: February 8, 2018
Results First Posted: March 9, 2018
Last Update Posted: May 16, 2018