Recruitment Begins for STEADY-PD Phase III Trial of Isradipine
 

Recruitment has begun at multiple sites across the US and around the world for the STEADY-PD Phase III trial to test the effectiveness of isradipine on slowing the progression of PD. Isradipine is a calcium channel blocker currently approved to treat hypertension. This is a very important study as there are very good pre-clinical studies to support the hypothesis of isradipine being neuroprotective; long-term epidemiology studies have shown a lower incidence of PD among people who take certain types of calcium channel blockers; the science behind the hypothesis makes a lot of biological and chemical sense; and the drug is already approved with a well known safety profile and minimal side effects.

The study is sponsored by The Parkinson Study Group (PSG) with support from the National Institute of Neurological Disorders and Stroke. MJFF helped fund the successful Phase II study. The link below provides more details and a list of site locations.

The study is limited to early stage (less than 3 years) PWP.

http://steadypd3.com/

You must be drug free.

did nothing for us off label
 

I believe this is a drug we tried off-label a few years ago: no effect. To be fair, perhaps you have to take it for a long time, and as BB99 noticed, you have to be drug free (meaning very early in the game) and I am pretty sure we were already taking sinemet when we tried it (with the approval/blessing of a very well known PD doc, I might add).

Hope it works for the newbies:)

I hope this helps folks but don't think it will. Maybe more studies should be done with adult stem cells! I think that may show better successes.

A few comments in response:

The drug would not really be expected to have any symptomatic effect. It's use, according to the theory, would be to slow cell death and, hence, slow progression. So, yes, you would need to analyze the effects over years. The new study will be for three years.

You don't have to be drug free to use isradipine. It has very little interaction with other drugs so take anything else you want. You have to be drug free for the trial only so the researchers can rule out their impact on any results. It's strictly due to study design.

You don't need to be early stage to use the drug. Once again, this is strictly due to study design for two main reasons: first, as you said, it's easier to find people who aren't taking other drugs; and second, as with research on other potential neuroprotective interventions, you're more likely to find efficacy the earlier you begin treatment. There are more dopamine neurons left to save.

I have researched this drug extensively over the past two years, including speaking with the lead investigators of this trial and biologists who specialize in basil ganglia health. I am also the PD advocate for this trial for the U of Penn and the Atlantic neurological Inst in NJ.

I'm not going to give anyone any medical advice, but I would be more than happy to share what I learned with anyone interested. As someone who believes in using proper clinical trials to test hypotheses, I do hope this study gets the needed volunteers (336) so we can determine if the drugs really is neuroprtective.

I have no idea if the drug will work, that's why we play the game, or in the case of disease, why we conduct the trials. However, the science behind the theory is enough to convince me that I would rather spend a few bucks a month (less than CoQ10 that we all take or took) and find out in 5 years it didn't work, than sit on the sidelines watching and find out it does work. Of course, like any other drug you should first discuss its potential use with your doctor, particularly if you are hypotensive.

Regarding stem cell research, I too would like to see more of it, along with research in several other areas, like growth factors and vaccines to prevent protein misfolding. We all can have opinions, but no one knows in the end which will or won't work.

I was contacted to be in the study which I gladly agreed. However once they found out I'd been on Azilect for more than three months I was told I couldn't participate. Very disappointing.

on Isradipine 5 years...
 

After I first heard about Isradipine at a PAN meeting 5 or 6 years ago, I contacted my neurologist and asked if I could take it. She said since I was already taking something for hypertension, that she would agree to the switch.

I was already on meds, and Isradipine wasn't in clinical trials yet -- just being researched. Did Isradipine help? I have no clue. I can say that the first 8 years my progression was very slow.

I started a very fast (frightening) decline as a result of being under a lot of stress caring for first one parent and then the other parent with dementia. Stress did me in.

jean :eek:

Thanks for trying to volunteer, Betsy. I'm sorry it didn't work out. I think the Azilect exclusion criteria is going to severely limit the potential volunteer pool.

My doc told me that they were basically looking for drug naive recruits at his hospital.