Tirasemtiv Updates?

[Ed340hp]

The history here looks sparse. Any updates?

I started with the initial open label dose this week. The qualifying visit seemed to be my clinics first. I am apparently the local test subject, so the visit took awhile to work out the details.

My muscles seem a little more responsive, and at times the heavy feeling goes away (until I get moving). The muscle fatigue has not changed, and I dozed off this afternoon (something I have not done in months). I was warned that it can react with caffeine, so I only get one morning coffee now. The good is they say beer is OK, and no problems there. It's hard to say if there is anything more going on than the normal good day or bad day feeling.

I read some others dropped the trial due to side effects.

Is anyone still in the trial?

 

[Statius@]

I started the open label part of the trial this past Thursday. I also started baclofen (replacing cyclobenzaprinte) about the same time, so I can't be sure which drug is causing what reaction, but I am noticing some lightheadedness/dizziness. I swam 1400 yds Friday (before I'd noticed any dizziness) and felt pretty good throughout the swim, but it seems too early to attribute effects to tirasemtiv.

The trial is based at the Univ. of Iowa Hospitals Neurology Dept. (I'm being seen for ALS at the Iowa City VA ALS Clinic nearby) and they, UIHC, seem to have a number of participants in the trial already.

 

[Vikman]

My dad started in December but dropped out in February because he couldn't take the side effects. Specifically the headaches and drowsiness. The trial doctor was telling us a few others dropped out as well at this site because of the side effects. My dad didn't notice any differences while on Tirasemtiv but he also was miserable the whole time he was on it so who knows.

 

[notBrad]

I didn't even make it past the open label phase due to fatigue and depression (and I'm not often depressed). IMO it was due to the dumba$$ requirement to take both the AM riluzole dose and the AM tirasemtiv at the same time...

 

[Ed340hp]

I never started the riluzole. The other PALS in the ALS clinic were about 50/50 on side effects, and none seemed to think it was helping so I never started (that, and my insurance would not cover it).

I had a little spacyness the second day. Not dizzy, but like an antihistamine buzz with a cold. I figured it was from taking the tablet with a coffee. Yesterday and today were better.

I am not on anything else, so it's not reacting with anything else. Maybe that is good.

So far I feel like muscles that I have not been using for awhile are getting sore. I gained some finger mobility or dexterity, but with soreness where I could not flex or move very well for the past month or so. Buttons are still a no-go.

I could turn a screwdriver using my thumb and index finger to adjust the idle mixture on my car, slow with minimal strength, but better than the past few months. I also held a comb in my right hand and ran it up through my hair this morning without both hands to steady it (it's the little things).

 

[notBrad]

I never started the riluzole. The other PALS in the ALS clinic were about 50/50 on side effects, and none seemed to think it was helping so I never started (that, and my insurance would not cover it).

I had a little spacyness the second day. Not dizzy, but like an antihistamine buzz with a cold. I figured it was from taking the tablet with a coffee. Yesterday and today were better.

I am not on anything else, so it's not reacting with anything else. Maybe that is good.

So far I feel like muscles that I have not been using for awhile are getting sore. I gained some finger mobility or dexterity, but with soreness where I could not flex or move very well for the past month or so. Buttons are still a no-go.

I could turn a screwdriver using my thumb and index finger to adjust the idle mixture on my car, slow with minimal strength, but better than the past few months. I also held a comb in my right hand and ran it up through my hair this morning without both hands to steady it (it's the little things).

That makes sense. I also noticed an increase in strength but unfortunately it came with increased spasticity...


Is that on the Vette? Let's see some photos of that beast !!!!

 

[Atsugi]

I moved it

The photos were huge, so I decided the post should be in the Hope thread.

 

[Ed340hp]

I moved it

The photos were huge, so I decided the post should be in the Hope thread.

Thank you. I'll pick it up over there.

 

[scaredwifetx]

Steve is still in the trial but has not noticed any side effects or any changes. I guess that could mean he is one of those who are getting placebo.

 

[Statius@]

I decided to end participation in the tirasemtiv trial after the two week open label phase. The lightheadedness/dizziness when the study drug was taken with riluzole was too unpleasant to make me want to continue. Besides it would have been nearly impossible to keep the double-blind phase of the study blind in light of the symptoms. Disappointing, but the medical staff indicated I wasn't the only one. I also noticed increased weakness in my legs (I walk with a cane and collator), but that could have been "normal" progression.

 

[Ed340hp]

I decided to end participation in the tirasemtiv trial after the two week open label phase. The lightheadedness/dizziness when the study drug was taken with riluzole was too unpleasant to make me want to continue. Besides it would have been nearly impossible to keep the double-blind phase of the study blind in light of the symptoms. Disa2ppointing, but the medical staff indicated I wasn't the only one. I also noticed increased weakness in my legs (I walk with a cane and collator), but that could have been "normal" progression.

I have heard of others with problems when taken with riluzole.

So far, I am almost a week into the trial.

It is strange, as I have gained back some range of motion, and muscles that I feel I have not used much lately are more sore. Still have good and bad days as far as fatigue and strength.

Muscles want to move, and position with more range, just not the strength. Warm up is still needed to get past the stiffness. Some imbalance feelings when the body feels like using and trusting muscles that lack strength. Where adaptation was how I coped before as muscle and movement range deteriorated, the mind now wants to control movement in a more natural way as if it is getting feedback from the weaker muscles. My mind thinks I can stand up free of help, but muscles are not there yet (where before I felt more like the muscles were not there with no chance of free movement).

Some spaceyness with the trial dose, more than open label. It is less after the first few days. Maybe washing down the tablets with beer was not a good practice .

More twitchy lately. Maybe good for muscles that seemed dormant before.

Too early to say much more.

 

[notBrad]

I have heard of others with problems when taken with riluzole.

So far, I am almost a week into the trial.

It is strange, as I have gained back some range of motion, and muscles that I feel I have not used much lately are more sore. Still have good and bad days as far as fatigue and strength.

Muscles want to move, and position with more range, just not the strength. Warm up is still needed to get past the stiffness. Some imbalance feelings when the body feels like using and trusting muscles that lack strength. Where adaptation was how I coped before as muscle and movement range deteriorated, the mind now wants to control movement in a more natural way as if it is getting feedback from the weaker muscles. My mind thinks I can stand up free of help, but muscles are not there yet (where before I felt more like the muscles were not there with no chance of free movement).

Some spaceyness with the trial dose, more than open label. It is less after the first few days. Maybe washing down the tablets with beer was not a good practice .

More twitchy lately. Maybe good for muscles that seemed dormant before.

Too early to say much more.

Maybe more beer needed... Remember, when it comes to beer never waste an empty stomach!

 

[Statius@]

I should have mentioned that I had not noticed any benefits though probably there wasn't enough time for any to materialize. Didn't think to try beer though, it's not my favorite drink at 6am. If there turn out to be real benefits as hoped, I think, based on my sample size of one, that they'll need to address the interaction with riluzole, or perhaps it would replace it.

 

[Ed340hp]

Trial continues for me. I think I have some improved range of motion.

Strength is weak. Dexterity no worse, and no better.

Found dealing poker hands is tough. Maybe it will improve. Heaven knows my game can use the help.

 

[krnNdug]

I have been in the trial since Jan. I didn't think to ask for my breathing numbers until the last two visits. I still don't know how I got in when my FVC went from 68 to 54. Dr suggested trying for the other 2 trials going on at our clinic so I did. When I blew for the SVC they were shocked I blew what I did (I don't know what it was) so we did it again and I was able to do the Tirasemtiv trial. I was sure I would have strong side effects since I did with riluzole. I slept the 1st couple of days and a little lightheadedness, but nothing else.

When the switched me to either placebo or increased dose I slept and had a little lightheadedness. Of course that could be from going off the meds, but I think not. My SVC was 89 and the next visit it was 88. They have said my extremity strength has been good except in my left leg, which I didn't think could get worse but has. I go back next week for my monthly check up. Looking forward to my SVC numbers. My sniff numbers have usually been between 90 and 100, with getting to 110 once in a while and down to low 70s.

I leave the visit feeling beat up, but I don't mid at all. We need to find a cure. I heard from a couple of scientists and doctors in DC that there is a drug coming soon that has a lot of promise.

Doug