I formerly dropped out of the AM-101 study this week while in the 2nd round. I wasn't seeing benefit from the drug. While I intended to stay on through the end regardless of my outcome, I was rather disenfranchised by some of the events that took place this round. I came to the conclusion that the study was sloppily written and designed. It was a waste of my time to continue when I could be doing other things to help my tinnitus.
When you join AM-101 you are given a disclosure document that explains the study. The second round disclosure document has contradictory instructions about what will take place. Specifically, in one section documents says the followup visit is measured from the first injection visit, and then on the following page the followup visit begins on the 3rd injection visit. This is a huge discrepancy as the it indicates the followup visits will be performed at different times for different patients. From the disclosure document:
Each dosing cycle is divided into 2 periods:
• A Dosing Period with 3 scheduled dosing visits over 3 to 5 days; and
• A Follow-Up Period with 3 scheduled follow-up visits, one after about 10 days, one after about 35 days, and one after about 84 days after the first dosing visit in each dosing cycle.
--------then on another page------
Follow-Up Period
Each dosing cycle has a Follow-Up Period with 3 scheduled follow-up visits, one after about 10 days, one after about 35 days and one after 84 days. The Follow-Up Period starts after the third dosing visit of each dosing cycle.
I also experienced incompetence from the staff who managed the trial at the Santa Monica, California site. On my first day of the second round I told the trial rep I was ready for my blood and urine test. She told me it was not needed. I reminded her it was in the study document. She told me no, because I was continuing it was not needed. I also did not have my physician exam either. Then on the third injection day they figured out that I needed and did these tests and exams then.
Then they forgot about me for my first 10 day follow up and that got done on Day 15 (based on the waiting period starting on day 1). They gave me little notice for the appointment and I had to juggle work scheduling to make it.
Another reason I dropped was being treated badly by the ENT office performing the injections. On my second injection I was in the chair, with the doctor ready to inject the compound. Then the lead doctor came in called out my doctor, and the next thing I know I was being led to the waiting room where I sat for almost and hour and a half. Turned out they needed the room for a paying patient of the practice. On other visits I was moved during the 30 minute waiting period because they needed the procedure room for other regular patients. I was forgotten about on one of my waiting periods and ended up waiting for almost 45 minutes. On my 10 day follow up visit I waited almost three hours to have a hearing test and doctor follow up because they kept bringing paying patients into the audiologist ahead of me.
After the first followup visit I made the decision to drop and scheduled an appointment with Dr. Nagler in Atlanta to start Tinnitus Retraining Therapy or TRT. While on AM-101 patients are not allowed to use any other therapy and I figured it wasn't worth my time to put off what could make me better.
I researched various non-medical therapies and TRT made the most sense to me. I shopped around for TRT practitioners and I was really impressed with Dr. Nagler's background and enthusiasm. I figure if I was going to spend the effort on this treatment I might as well find a good clinician to administer it.
TRT is not inexpensive as there are the meetings with the clinicians, the equipment, and transportation and hotel. I was able to get some rather inexpensive airfare from Los Angeles to Atlanta for my wife and I. We used Uber to get around and found a reasonable hotel close to Dr. Nagler's office. I really lucked out with equipment as I was able to find a lightly used set of simplicity noise generators for $600 on ebay. They came from a lady that used them to get over misophonia and used them less than two months. Otherwise it would have been $1800 for new devices.
We spent two half days with Doctor Nagler and his audiologist named Doctor Rushton and got started with TRT. I had a good positive experience, but I won't go into this further as it is outside the scope of the AM-101 thread. In the future I may write about my experience on the proper area of tinnitus talk.
i reached out to many people here..so for the newbies or anybody that needs support please dont hesitate to send me a personal message. Cheers
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