Clinical Trials

[smv123]

Has anyone participated in ANY Clinical Trials?? Which ones and have they helped at all???

[DopamineWarrior]

hi, only ones I have participated in are the gene detection, to see if I carry the LRRK2/GBA1 genes.

[Furch in reply to DopamineWarrior]

My wife did a study with alternating hot and cold application with headphone device at Winston-Salem, Wake Forrest. It was about 16 weeks and she used the device 20min twice/day. She underwent a pre trial MRI and then mid test and then after the study. I don't believe this was a placebo effect. She showed improvement, less freezing of gait, improvement to depression and generalized improvement. However after study was completed she went back to her pretrial status and since then has been digression. It was almost like a cruel situation. To be doing that well and then No apparent positive residual benefits. Neuro-modulation has been shown effective in other studies be it Dr Tass and his gloves, which many of us have tried to reproduce. The CUE1 by Charco Neurotech available in the UK . Red light therapy available in Canada, even fecal transplant. Changing the GI microbes have been researched

I am sure there are many " snake oil medicine "rip offs. But there are some real off the wall ideas that actually make sense. There's studies on Focus Ultrasound, and of course there's the Stem Cell studies. This is only my opinion but I feel that greed has contaminated studies and perhaps drug companies are resistant to non- pharmaceutical treatment. More money in pills than natural remedies and vibration devices. Although the US Congress has declared dedication to PD. Surely they will find that there will be sub groups of PD and with that there will likely be various treatments that will be specific to the type of PD. What is worse is that PD is growing out of proportion to our population and soon PD will unfortunately be a popular disease and if we are behind on research we will be chasing our tail trying to catch up to rest of the world. Sorry I get very winded and opionated when it comes to PD as I watch my wife who, by the time she got accepted to a cane is now 100% walker dependent.

[NextStage in reply to Furch]

MBAnderson Note that Donald mentions that the hot/cold applied to alternate ears helped his wife's freezing of gait. Last Fall I looked up the study to which Donald referred and I think they were still taking participants. Because you have to do several MRIs, and I have claustrophobia and can only handle an open MRI, I didn't try to do it. Maybe you should consider either the trial or getting some device like this.

[MBAnderson in reply to NextStage]

Thank you. Which study are you referring to?

[Furch in reply to MBAnderson]

The study is at Wake Forrest in Winston Salem North Carolina. I will say that the team is extremely professional , enthusiastic and friendly.

[Salted]

I'm in the midst of participating in a couple of clinical trials. One is a longitudinal study gathering data about mobility and disease progression in PD. It's not meant to treat my PD, but to help researchers. This is the study: studypages.com/s/digital-ma...

I'm also in my 3rd week taking a tyrosine kinase inhibitor, or maybe a placebo. I'm in the 201 trial: inhibikase.com/patient-reso...

Hard to say if it's helping or not. I am not taking levodopa or any other Parkinson's drugs. I try to keep up a physical exercise program, see a PT every few weeks. I have a leg tremor on the right side and sometimes a hand tremor on the right, experience periods of fatigue, constipation, urinary urgency. I have some gait issues, but PT helps a lot, and I jog/run 3-4X/week without any problems. I was officially diagnosed in November 2023, had an abnormal DaTscan in August 2023, have had symptoms since late 2021 or so. My condition remains pretty much about the same, not progressing, not improving.

[MBAnderson in reply to Salted]

I screwed up.

I tried to get in the inhibikase study, but made the mistake of being truthful about having tried C/L 3 or 4 times for 2 weeks at a time most recently a couple years ago, but the intake person said I didn't qualify because I had taken levodopa more than 28 days.

Last time I make that mistake.

[Stillstandingstill in reply to MBAnderson]

I wonder why that would exclude you. Presumably it had been clear of your system a long time.

[MBAnderson in reply to Stillstandingstill]

Right. In addition it said "not receiving levodopa within 90 days." I believe the intake screener got it wrong. I asked her to check with the doctor, but have no way to verify her doing so. Boo-hoo.

[Stillstandingstill in reply to MBAnderson]

Frustrating!

[Salted in reply to Salted]

I don't know if Inhibikase will be helpful to me at all, but I get a lot of benefit from participating in this study, as well as the longitudinal study. Both are being done at Oregon Health Sciences University. During screening and baseline exams for these 2 studies, I was seen by four neurologists and at least a half dozen research assistants. Some of them have years and years of clinical and research experience. Some are young and excited about research. All of them were happy to talk about PD, PD research, medications, my specific symptoms, etc. That's helped me a lot, emotionally. The healthcare system in the US often means that we might get 10 minutes with an overbooked doctor twice a year and not much guidance, attention, or assurance from anyone. Being able to chat a little with doctors and researchers has been educational and kind of comforting.

[Ctime in reply to Salted]

Well said!

Being on a first name basis with your care team, having them know about you, your interests, your family, your goals. Putting a face to a few of the thousands are actively looking for solutions. Knowing that if you had a crisis or even a question, you can pick up the phone and reach someone who knows you by name.

Then there are the existential issues. When you realize that the rest of your life is going to be more imperfect than you had hoped; that you are not going to be able to achieve some of the things you thought you could, how are you going to create purpose? I cant solve homelessness or climate change or a lot of other things but there are 10 people every hour diagnosed with PD in the US. I CAN help them even if my contribution is only showing what does not work.

Yes, categorically, the trials that I have been in have helped me with my disease.

[7springshollow]

Check out the trials at Hope Bioscience in Houston TX. They are doing good work. Their trials are FDA approved. They are seeing good success. Let me know if you want more info. Participating in trials is essential if we want to see any progress made on curing this condition.

[MBAnderson in reply to 7springshollow]

participant criteria

"Study participants must have previously banked their mesenchymal stem cells with Hope Biosciences."

[7springshollow in reply to MBAnderson]

That trial is done. The new trial doesn't have that requirement.

[7springshollow in reply to MBAnderson]

clinicaltrials.gov/study/NC...

[MBAnderson in reply to 7springshollow]

thanks

[bassofspades]

I started to do one clinical trial. They were offering about $5000 or something like that. I did all the preliminary testing and they paid me each day I went in. But when I took the first dose of the drug, I had a terrible headache that lasted 3 days, so I dropped out. The drug was called Tavapodon or something. I posted the details here healthunlocked.com/cure-par...

[Ctime]

Absolutely I have experienced a benefit from the clinical trials I have been in, just not from the drugs (yet!)

While it is a reasonable motivation, rationally it is a mistake to participate in an individual trial expecting a disease modifying benefit. The odds of an individual drug making it to market is low, during a trail you might get the placebo , and even if you are part of a successful trial, there are likely to be long treatment gaps as the drug moves forward.

However, my experience is very much like Salted. I can pay a lot of money for very little with care that is largely based on 40 year old drugs. Or I can be an active participant in a community that is trying to solve this problem.

Just like posting here, the benefit comes from the community.