Pagoclone Study

This is the end..... (to be continued)

2010-09-02T21:18:00.000-07:00

The Pagoclone study is wrapping up - with results the drug company finds less than compelling, according to my contact at the research center that's been administering my participation in the study.

Many subjects, he tells me, have reported similar effects as those I have experienced: reduced tension in the larynx and/or articulators and at least some improvement in fluency. These positive effects are not powerful or compelling enough for the drug company to push for FDA approval at this time. My contact thinks they will engage in another study at a higher dose of the drug, with the hope that it will yield more promising results.

I am on my last three bottles of Pagoclone and will return to the research center in November for a final visit.

Control

2010-06-29T12:12:00.000-07:00

For reasons generally beyond my control, I stopped taking Pagoclone for three weeks.

What happened?

Within a few days I noticed I was stuttering with greater frequency and intensity. I became aware of a general tightness in my throat and (to a lesser degree) articulators that I believe ontributes to disfluency.

I tried using some of the techniques I generally employ to prevent (as in Airflow Technique) and minimize (as in Precision Fluency Shaping) stuttering.

Without Pagoclone, I found it more difficult to apply these techniques - more difficult to maintain composure and exercise control over my speech.

Back on Pagoclone for one week now, and I'm starting feel like I'm getting back on track.

Stuttering is Cool - Podcast

2010-04-13T11:12:00.000-07:00

I used to be a frequent listener of many podcasts a few years ago: Daily Source Code was part of my commute each day and Dawn and Drew were friends I'd never meet. But then somehow I got out of the habit of listening and pretty soon they were but a distant memory....

Anyway, No Agenda rekindled my interest in the medium (though, in truth, I generally listen to the stream rather than the podcast) and now DSC is back, albeit sporadically. And I've found a stuttering podcast that caught my interest: Stuttering is Cool.

Daniele Rossi hosts this show from Toronto, where he incorporates conversations with and interviews of people who stutterer in a free-form, entertaining show.

The current episode (#79) is a really interesting conversation with a friend in a busy restaurant. Danny's friend Jaan describes his experiences with speech therapy programs like Precision Fluency Shaping and his largely independent efforts to gain better control of his speech.

Jaan does a great job of managing his speech - he describes the effort in terms of timing and coordination.

I totally get what Jaan is saying, and I'm impressed by his dedication. Take a listen to this show, and I think you'll agree.

Danny is a really creative and interesting guy. He and I spoke about Pagoclone the other day - parts of our conversation will likely appear in a future episode. I'll let you know when it's posted.

My Starbucks barista just brightened my day

2010-04-02T17:29:00.000-07:00

I'm not a daily customer, but the people at my local Starbucks know me well enough from my once-a-week-or-two visits.

One barista has always been particularly friendly. She told me once that her little brother stutters, and to take my time placing my order, that she's in no hurry.

She's really a great employee, as evidenced by the huge spread of MUGs on her cap. But anyway, today I popped in to get a coffee, placed my order, and she burst out - "You sound so good!!"

It was then that I realized I had been totally fluent in exchanging greetings and placing my order.

I've been on the higher dose of Pagoclone for about 8 weeks now (.6mg, twice a day), and I am noticing substantial improvements in my ability to manage my speech.

Let me be perfectly clear:

I still stutter.

Pagoclone is not a stuttering cure.

But Pagoclone does help me exercise greater control over my speech. Specifically, I am experiencing a substantial, sustained reduction in tension in my larynx and (consequently, I believe) my articulators.

My overall tension level seems lower as well. And as a result, I am better able to employ the speech management tools I've learned in a lifetime of speech therapy.

For the most part, I utilize the airflow technique developed by Dr. Martin Schwartz. Many traditional speech therapists don't give this guy his due, but I believe his stuttering prevention approach is rock solid.

I'm happy to be continuing in the Pagoclone study. I have experienced no side effects or problems. I'll keep you posted. Thanks for reading.

The Whole Truth

2010-03-29T17:18:00.000-07:00

When the good folks over at "The Stuttering Brain" posted information from a reader that the Pagoclone study was locked and results were known, my first thought was "Tell me it isn't true!" Well, not really, but I wanted to get that Dylan link in there.

Anyway, what I really thought was, "That's odd.... no one said anything to me about that." And as it turns out, no one said anything to me about it because....... It's not true!

I met with my contact at my local research center today, and she confirmed that I am in week 16 of a 48 week open label testing phase. My participation in the study will (sadly) come to a close at the end of 48 weeks, but the study will go on until everyone in the program has reached 48 weeks of open label testing, according to my contact.

Even after all the participants have concluded the 48 week open label testing stage, it will take them at least a year to analyze the data they've gathered through these research centers before (hopefully) presenting it to the FDA.

Just wanted to squash the rumors that the study has wrapped and results are known - the Pagoclone study is definitely still going and the analysis is yet to come.

Oh, and it's working for me. More details on that in my next post.

The End is Near?

2010-03-25T06:55:00.000-07:00

There's been some talk about pagoclone over at Tom Weidig's excellent blog "The Stuttering Brain" recently.

http://thestutteringbrain.blogspot.com/2010/03/pagoclone-data-locked-results-known.html

I can't confirm his reader's information about the Pagoclone study closing. I'll try to find out more information from my local research center and will advise.

Does it run in the family?

2010-03-19T11:48:00.000-07:00

Interesting news from the U.S. Government's National Institutes of Health; it seems that researchers may have identified a genetic link to stuttering.

Read more about it here:

http://www.nidcd.nih.gov/news/releases/10/02_10_10.htm

Research is ongoing, and the NIH is still recruiting participants that fit their specific requirements. If you think stuttering runs in your family, you may be able to help them with this research. Check out the details here:

http://www.clinicaltrials.gov/ct2/show/NCT00001604?term=00001604&rank=1

Higher Dosage

2010-03-12T08:56:00.000-08:00

It's been a while since I've posted, but I have some encouraging news for people interested in using Pagoclone in the medical treatment of stuttering.

I have been on the higher dosage (.60mg) for about a month and half now, and my speech is noticeably better.

I am still stuttering, but my blocks are less intense and less frequent. I also feel like my baseline stress level has fallen, as the tension in my throat is noticeable by its absence.

I've even been in some extremely high pressure situations (well, high pressure for me, anyway) and I've been able to retain my composure and speak more fluently than I would have before using Pagoclone.

Side effects? I really haven't noticed any.

I am not touting this as a "cure for stuttering" by any means, but I do believe Pagoclone is helping me manage my speech, and I'm encouraged by the results so far.

Open Label Testing

2009-12-11T12:17:00.000-08:00

At last, the double-blind phase of the drug trial is complete, and I have moved on to the open label phase of the Pagoclone stuttering study. That means I'm definitely getting the real thing - not placebo - and I can finally get a clearer picture of what this drug can (and can't) do to help me control my speech.

Just a few days into it, but I'll be reporting back here soon.

It's been a while

2009-09-30T08:55:00.000-07:00

It's been a while, but I'm still at it. The Pagoclone study continues - with negligible effect for me. Maybe it's placebo, maybe it's a reduced dosage, or maybe it's just not working for me. A little disheartening, I must admit. But we'll keep going and see what happens. Another visit to friendly folks at the research company in a few weeks. Will let you know how it goes.

Under Pressure

2009-07-28T09:06:00.000-07:00

It's been more than a month since my last visit to the medical research company - I finished the first bottle of pills last week. I'm on the second bottle now, one pill in the morning, in at night.

The ever-present tension in my throat is somewhat reduced, and I can only attribute that to the medication. This reduced tension results in generally improved fluency highlighted by fewer, shorter and less intense blocks in my speech.

I've noticed this at work, on the phone with family and friends and in a few other social situations. BUT...... when I am tired or rushed or feeling stressed, this sense of reduced vocal tension disappears and my speech is as disfluent as ever.

Maintaining composure when speaking is the key to speaking more fluently, at least for me. When I cave in to the pressure I'm inevitably feeling (in varying degrees, according the situation and my relative state of being at the moment), my speech suffers.

Achieving and maintaining a measure of composure when speaking is something I need to focus on in order to speak more fluently.

Pagoclone can help me with this. It's not going to "cure" my speech problem. But it can be a useful tool as I work to improve my speech.

And for the record, I've kept up with my doses on schedule and have experienced no side effects.

Next appointment August 18.

Could You Be The One?

2009-06-24T11:10:00.000-07:00

Another visit to the medical research company, another questionnaire, another video recording.... and two more bottles of pills.

As I cracked open Bottle 1 (which is really Bottle 4 in total, but Bottle 1 of this, the second 8-week stage of the the first testing phase), the old Husker Du song popped into my mind - could you be the one?

For the next eight weeks, I'll be taking these pills, which may or may not Pagoclone. And my speech may or may not improve. In the video reading yesterday, I was 90% fluent, an exceptionally high fluency rate. But back in the office, in my everyday environment, I pick up the phone and ....... Well, it makes no sense at all.

Nothing new to report on the new batch of pills. I still feel some tension in my throat, and my stuttering is only moderately improved, if at all. No side effects at all. I'll post in a week, hopefully with the news that the tension in my throat has diminished - that would be an encouraging development. Will advise.

A week from tomorrow...

2009-06-15T10:25:00.001-07:00

I am scheduled to go back to the medical research center a week from tomorrow. I've been in full compliance with the medical directions, not missing a dose since the first day of the trial. I am still on bottle three, which, as I've mentioned before is either placebo or an ineffectively low dose of Pagoclone.

From my experience with bottle one, I know Pagoclone can help me speak more fluently. Not by itself - the pill is not a cure by any means. But in conjunction with speech therapy (for me, that's mostly stuttering prevention techniques along with some fluency shaping techniques), I know that Pagoclone can be a useful tool for helping me control my speech and speak more fluently.

Update

2009-06-08T13:48:00.000-07:00

Ok, I've gotten an update from the medical research company. I had hoped after finishing the first three bottles of pills, I'd be moving on to the open label phase, in which I would definitely be getting Pagoclone.

It turns out that the current phase of the trial will continue for another 24 weeks - for a total of 32 weeks. It is only after this that I'll be able to move on the the 48 week open label phase.

Just wanted to clear that up for any of you who are also participating in the trial: It's a double-blind test for 32 weeks, then open label for 48 weeks.

My take on Bottle 3

2009-05-29T10:51:00.000-07:00

I feel like it is possible that Bottle 3 may be Pagoclone, but, if it is, the dosage is much too weak for me. I felt a little less tension in my throat after taking pills from Bottle 3 for a few days - but the difference was very, very slight. Stressful day at work today, and I feel the old, familiar tightness in my throat even as I type this.

I'll discuss it with the medical research team on my next visit, but I feel certain that Pagoclone - at a certain dose - can help me speak more fluently by reducing the tension in my throat. And if I pair this medical treatment with stuttering prevention techniques (passive airflow) and fluency shaping techniques (gentle onset, light contact) and speak at a moderate pace - I think I can achieve a higher degree of fluency than I could by using any of these components on their own.

The medical treatment of stuttering will likely be most successful in tandem with speech therapy, imo, and I am eager to move forward and more fully explore this approach.

Three of Three

2009-05-27T06:58:00.000-07:00

I started the third bottle of pills yesterday. One pill, twice a day, for the next two weeks. I don't notice an immediately discernible effect.

To recap: the first bottle (two pills, twice a day, for two weeks) seemed to alleviate the constant tension that resides in my throat. I had grown so accustomed to that feeling that it was only noticeable by its absence. My speech improved during those two weeks. I still stuttered plenty, but the blocks were fewer in number and significantly lower in intensity. I believe this first bottle was Pagoclone, not placebo. No side effects.

The second bottle (one pill, twice a day, for two weeks) seemed to have no effect. The beneficial effects of the first bottle disappeared within a day or two of moving on to the second bottle. No side effects.

Now I am on the third bottle - I feel no change so far.

My followup appointment with the medical research center is June 20, at which time I hope I can begin open label testing of Pagoclone.

And this is what they call.... placebo

2009-05-18T10:20:00.000-07:00

I've been on the second bottle of pills for a week now, and I know these are placebo, not Pagoclone. I know this because the tension in my throat has returned to full strength and my speech has reverted to "normal" - that is, I am stuttering as I always have.

It is remotely possible that this second bottle is still Pagoclone but at a much smaller dose, but I doubt it. When taking pills from the first bottle, the tension in my throat - the tension that was always present, even when relaxed and not speaking - that tension was gone. Disappeared.

As a result, my stuttering was far less intense. I could even exercise a degree of control over my speech with an ease I had not previously experienced. I am convinced the first bottle was Pagoclone and this second bottle is not.

I start a third bottle soon. Will advise.

2nd Bottle

2009-05-13T06:34:00.000-07:00

When I started the Pagoclone drug trial a couple of weeks ago, they gave me three bottles of pills to take over the course of a month and half. I finished my two weeks on the first bottle and have now switched to the second bottle. For these pills (which look identical to the ones from the first bottle), I am taking two pills per day, one in the morning and one at night.

I have not noticed any changes so far, but I'm just on my second day of the new dosage. As with the first bottle, I have not experienced any side effects at all.

Of course, any of these pills (from any of the three bottles) could be placebo. Or they could be Pagoclone. It's a double blind study, so not even the medical company running the program knows if I'm getting placebo or Pagoclone. For what it's worth, I feel pretty certain that first bottle of pills was the genuine article.

Update

2009-05-08T18:52:00.000-07:00

I've been taking the first round of Pagoclone (it could be placebo, but I'm 100% certain it is Pagoclone) for a week and a half, and I'm really convinced this is helping me speak more fluently.

I am still stuttering. But blocks are shorter, far less intense, and generally fewer in number. I am not supposed to be using speech modification techniques, but I had to do an interview with a (sort of) important person the other day, and I used the air-flow technique with great success. If you don't know about the air-flow technique, check it out. Good stuff.

Anyway, I only used air-flow technique for my interview and it went really well. I am consciously speaking as I normally would in order to more accurately gauge the effects of this drug.

I'm impressed with Pagoclone, and I am eager to get to the open label phase of the study so I can really try to use the speech modification techniques I've learned but struggled to consistently apply over the years.

Eighth Day

2009-05-05T19:14:00.000-07:00

Eight days in, am I hitting the wall? Particularly challenging day at work - increased base level tension, I'm sure - and my speech was a little worse today. Maybe it'll bounce back tomorrow....

I am so tempted to use speech modification (or stuttering prevention) techniques - specifically passive airflow - but I'm supposed to just see what the pills do (or don't do) on their own.

Even with the level of disfluency I experienced today, it was still an improvement over my speech prior to starting the trial.

I'm still enthusiastic about Pagoclone, I just need to be patient, I guess. Not my strong suit.

Sixth Day

2009-05-03T12:44:00.000-07:00

Ok, it's definitely working.

My speech has improved significantly. Still blocking, but brief, little blocks, not my standard constricted, grinding kind of block where I can't get a sound out. It's really rather strange. I tried using some technique today (I am a believer in the passive airflow technique developed by Martin Schwartz - and also use some tools from HCRI Fluency Shaping) and found I could use the air flow technique really easily when I was talking with a stranger this afternoon. This is not something I can generally achieve - generally my base level tension is too high, but not now.

I don't want to use too much technique right now because I still want to see what effect the drug has on my unmodified speech. But I am encouraged that I may find it easier to employ technique while using Pagoclone. I'll pursue that more when we get to the next phase of the study.

Fourth Day

2009-05-01T05:59:00.001-07:00

Interesting.

This may or may not be related to Pagoclone (assuming I have the real drug and not placebo - and somehow I do feel certain that I am on Pagoclone), but I have noticed a couple of things:

1. When I stutter (and I most certainly do stutter, all the time), my blocks seem to be shorter in duration and lower in intensity. Even on plosive sounds like "b" or "p" - sounds that almost always give me trouble. Rather than pushing (and pushing and pushing) through a clenched mouth to get these sounds out, I just kind of push a little and they go.... I am not using light contact or airflow or any of the speech management techniques I've learned. I am tempted to, but I really want to see what happens to my "normal" speech (though I realize my normal manner of speaking is not normal at all) while using this drug. I did not expect to see an effect on my speech so soon after beginning the drug trial, but I feel like my speech is improving.

2. I am sleeping better. I rarely sleep through the night but I slept through the night the last two nights - I didn't think anything of it Wednesday night but it happened again last night. It struck me this morning, as I woke up feeling rested when the alarm rang. I wonder if this is related to Pagoclone or a happy coincidence?

Third Day

2009-04-30T06:41:00.000-07:00

I'm on my third day of the first bottle of pills (two pills, twice a day). I'll continue this dosage for almost two weeks before switching to bottle #2.

No notable effects to report.

First Day

2009-04-28T07:14:00.000-07:00

I took my first dose in the Pagoclone study this morning. As per the instructions, I am to take two pills in the morning and two in the evening each day for the next few weeks. I would think it would take at least several days for any effect to manifest itself, but who knows? I don't even know if these pills are Pagoclone or placebo. We'll just have to wait and see.

I've got the pills

2009-04-27T12:00:00.000-07:00

A month ago I went to a medical office in Manhattan to see if I would be a good candidate to participate in a study on the medical treatment of stuttering using a drug called Pagoclone.

I filled out some forms, answered some questionnaires, sat for a videotaping (I had to read out loud and then speak extemporaneously for about five minutes), gave a urine sample (they want to be sure participants aren't taking mood altering drugs, I guess) and that was it. They said they would be in touch. A week or two later, they called to say I would be a good candidate for the study and asked me to return for a follow up.

I went back today, answered more questionnaires, gave another urine sample, had a physical exam and that was it. They gave me three bottles of pills that I will take (in varying doses, according the instructions) for the next two months. There is a chance, of course, that I have the placebo. But I hope, hope, hope I have gotten the real thing. I know it is not a cure - I know the best it can do it to reduce the intensity (and perhaps frequency) of my stuttering. And even if it is Pagoclone and not placebo, maybe it won't do anything at all. Whatever - I'll take what I can get.

These are the pills they gave me:

Kinda freaky looking, huh?

Anyway, I'll start taking them tomorrow (Tuesday, April 28, 2009).

I'll try to post to this blog to keep track of things during this initial two-month trial. This is really just for my own sake, but if anyone happens to stumble across this blog when searching for info on Pagoclone or stuttering, I hope you find this helpful.