Tuesday, December 28, 2010

In retrospect...

I have concluded what was for me, a unique experience. I participated in a clinical trial testing the efficacy of pagoclone for the treatment of persistent developmental stuttering in adults. My participation in the study came about largely by chance. Several years ago, I believe it was the fall of 2005, I had learned that a study was being conducted, and I even went so far as to speak to a representative about participating in the study. I decided not to participate at that time, largely because the closest trial site was in Atlanta, a five hour drive away.

I had forgotten about my previous contact when I was contacted about participating a later phase of the study. The earlier phase had suggested promising results, and the next phase was being opened to a larger sample to test the earlier results. I initially agreed to participate in the study in Atlanta, despite the distance. I went so far as to drive to Atlanta for a pre-study screening (to determine that I met the criteria for the study). Two days after the screening in Atlanta, I was contacted by a research firm in Raleigh about participating in the same study there. Since Raleigh was only two and a half hours away, I dis-enrolled in the Atlanta study and enrolled in the Raleigh study.

The initial 32-week phase was conducted as a double-blind placebo controlled study. Participants were divided into three groups. One group would receive .30mg twice a day, another would get .60mg twice a day, and one group would get a placebo. In addition, half of the first and second groups would get a placebo for 12 of the 32 weeks, while half of the placebo group would get .075mg twice a day. Neither the participants nor the investigators were aware of which group individuals belonged to. The efficacy was measured by videoing participants reading from a prepared script and talking to an investigator during office visits. The videos were scored to determine changes in the fluency level of participants. The second phase of the study was a 48-week open label trial.

Although I was never informed, and I have no reason to believe the investigator with whom I worked was ever aware, I judged by the results during the study that during the initial phase of the study that I was definitely getting at least a modest dosage of the drug. I saw a steady and noticeable improvement in my fluency over the first eight weeks of the initial phase and maintained that fluency level until after the second study visit, during the last 12 weeks of the initial phase, my fluency level decreased to baseline. The initial improvement did not result in a complete cessation of stuttering, but reduced the stuttering by more than 90% based on my estimates.

During the second phase of the study, I was receiving .60mg twice a day and the results were consistent with what I had seen in the first part of the initial phase. I was disappointed to learn the study was being suspended and the drug withdrawn at the end of the second phase. I was initially told I would continue to receive the drug until it was released on the market or drug was withdrawn. The results I experienced, while not "a cure," were the closest I have ever been to fluent in my 55 years. That I will miss. A lot.

Among the things I gained from the study was an understanding of the degree of anxiety present in my normal functioning level. Pagoclone was initially developed as an anxiolytic agent, and it was during the anti-anxiety clinical trials that its effect on stuttering was first noted. I suppose I have always known that I was a very anxious person, but since that condition was normal for me, I had no real concept of what it was to be relaxed. I knew my stuttering was worse when I was more anxious, but I stutter when I am "calm," so there was no reason for me to note a "cause and effect" relationship.

I was informed the drug was being withdrawn on my next to last study visit. I started doing some research, but nothing suggested an alternative anxiolytic that may affect stuttering. Prior to the study, I had taken several different herbs on a regular basis. I took St. John's Wort, which I had found to be effective in lifting the mild depression that had been my regular companion. I had used several other herbs, all of which I suspended for the study, but had found nothing which had produced the benefits from the study. One thing I uncovered during my independent research was something noting the classification of Valerian as a anxiolytic. I had used Valerian as an occasional sleep aid and still had some on hand. I decided to try substituting a twice daily dose of Valerian for the pagoclone at the conclusion of the study.

The study has been over for five weeks now, and I have been taking two Valerian capsules twice a day for that time (as I sleep aid, I was taking three capsules thirty minutes prior to bedtime). I can report that so far my fluency is better than it was before the study, but I have not had a real test to be able to measure how nearly the Valerian results approximate the results of the pagoclone. I have ordered another herb that I plan to add to my regimen, as I have some reason to suspect it may improve the Valerian results. I'll report more on my pagoclone replacement experiment after I have the opportunity to gather some more data.

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