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New news

Last Monday, my phone rings–it’s the coordinator from the University of South Florida (where my trial takes place). I let it go to voicemail, because honestly I was a bit nervous of why she would be calling. ‘Are they going to drop some bomb that I need to discontinue the trial I’m in?!’

When I call back, the coordinator actually has some exciting news. “We would like to invite you to participate in a new trial. The only thing is, you will need to make a decision within the week because the trial starts October 25th.” She continues to briefly explain the study and will be e-mailing me the consent form that explains all the ins and outs. Once I read the 13 page consent form, my head was spinning with questions and the possibility of unknown side effects. This study has never been tested on humans before; only on animals. Even though reports showed no side effects on animals, it’s still a nerve wrecking decision. We’re human, not animals–some weird thing could totally happen only to us, humans. 

After asking many people to share their opinion and shed some light on this trial, I made a decision and said “yes!” 

The study drug is called RT001 (why do all drug medications have to have such dumb, scary names? Why not ‘pretty in pink’ or ‘sparkle’? Those are such inviting names–that’s something I’d sign up for😉 RT001 is a slightly modified linoleic acid. Linoleic acid is a polyunsaturated fatty acid found mostly in plant oils. 

The purpose of this study is to:

-look at the safety and tolerability of different doses of RT001 given to people with Friedreich’s Ataxia

-measure the level of RT001 in ones blood

-determine the best dose of RT001 for future research studies 

-look at the effect of RT001 on ones ataxia symptoms and exercise capacity

There are two groups in this study: 1) either I’ll be taking the drug (1.8 g/day) or the placebo (inactive medication) 2 capsules will be swallowed in the morning. 2) I’ll be given the drug at a different dosage (4.5 and 9 g/day) or the placebo. 5 capsules will be given on the first and last day of the treatment period. The days inbetween, 10 capsules will be swallowed a day.

This is a double-blind study, which means neither me nor the study doctor will know if I’m receiving RT001 or placebo. The study drug and the group I’m in will be assigned by chance–like the flip of a coin. 6 of the 9 people in each group will be given RT001. So, as Miss Effie Trinket would say: “May the odds be ever in your favor.”

The part I did like hearing is that this study is only 1.5 months long. Because it is so short, I will have to make 4 trips down to Tampa in 3 week intervals. Once at the end of October. Twice in the month of November and the final visit will be 6 days in early December. It is a jammed packed, fast paced study. During my stays, I will be giving blood–approximately 2 1/3 cups of blood throughout the whole study… Wowza! Undergo an EKG and ECG. Have an exercise test–riding a stationary bike. Questionnaires, neurological exam and 25-foot-walk test. The part of the study I didn’t like hearing is modifying my diet. During the study and about 30 days after, I need to consume a diet low in polyunsaturated fatty acids. Linoleic acid is a polyunsaturated fatty acid, so it is very important to reduce all other sources of polyunsaturated fatty acids in my diet during the study. I will be given a diet coach during my initial visit, who will go over the foods I need to avoid, a recipe guide, etc. So, I did a little of my own research to see what is considered a polyunsaturated fatty acid food and here’s a few things I saw… 

 

   
   
I know I’m probably being a little dramatic, but think about it…those oils, nuts and beans are used in the making of SO many foods! I like to eat whatever I want, whenever I want…so this will be a major adjustment. This is only for a couple months, so suck it up, Erin! Plus, whenever I’m down in Tampa the university provides a personal chef to cook all my modified meals–can’t beat that! Now, I just need to figure out a way to get that chef to come back with me and cook ALL my meals😉

Now I know Lineolic acid is in foods, so why should I be freaking out if it’s something I already consume daily?! Well that should give me a little peace of mind, but the amount of Lineolic acid I could possibly be taking is a high amount and like I said before, this study has never been conducted on humans. The possible side effects are unknown–that’s the scary part. I mean what if ingesting high amounts causes some type of long term effect?! I don’t want to be negative Nancy, but you have to ask yourself these questions to be prepared for any possible outcome.  

I have many goals–I hope people don’t think I’m living it up with no job and I’m being a lazy bum because that is not true at all! I want so badly to get back out in the working world or maybe find an in-home job, but I’m not just going to settle for some desk job, pushing paper because I’m limited to what I can do. I want to invest my time into something I really enjoy and I know there’s something out there I will love doing–I just need to find it! I know my goals can be accomplished. I see and read stories about other FA’ers holding a career, being apart of the FA community and raising a family. I have the will to do this and I will find a way to reach my goals and expectations. 

In the mean time, the one thing I can do and be good at is participating in this trial. Even though I’m nervous, I need to bite the bullet. This is my way of giving. Someone close to me reminds me often: “God gives people only what they can handle. You were given FA because you are strong enough to fight it.” It’s nice to be reminded of that often. I need to hear that; especially on my tough days. 

I wouldn’t say FA is a blessing at all, but maybe a blessing in disguise?? It has helped me appreciate little things; take nothing for granted. And it has opened my mind to so many other disorders and disabilities that I probably wouldn’t have much knowledge about if I didn’t have a disability, myself. 

Ok, enough with all the sentimental stuff. I want to make sure to keep the ones updated that have donated and contributed to my fundraiser, gofundme page and personal contributions–that the money raised will still be going towards my participation down in Tampa for this new trial, just not for the supplement I was taking before (ALCAR). 

As I’ve explained in previous posts, the trial for ALCAR was a two year trial. Now, by participating in the new trial I will stop taking ALCAR. They are able to take the results and info for the one year I took ALCAR and use that for data. I am pretty sure the other participants in the ALCAR study will continue to take ALCAR for the remainder of the study, so data will still be able to be collected for the intended two years. 

Looks like I’ll be heading down to Tampa in two short weeks to begin! Since this is a short study, I will try to write every trip to Tampa to keep you all posted. 

Fingers crossed!

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