There are up to 5 phases involved in a clinical trial: phases 0, I, II, III and IV. … A phase III trial provides a detailed evaluation of a promising new treatment …Trials seldom make it past Phase 3, so this is significant as trials go.
This company is also conducting other research and trials posted on ClinicalTrials.gov more specific to various ataxias.
Keeping our fingers crossed!
Thanx so much 4 this. My neurologist says I have MSA and Ataxia. Now what? Who do I speak to?xoxo N
It can take years to complete a phase 3 study and get FDA approval. If you want to try earlier, you might talk to your neurologist about being part of the clinical study. There is some probability you would get the placebo. That
probability depends on the study design. You should also know that safety and effectiveness are not guaranteed in a clinical trial- that is the purpose of the trial. You might also contact the company making the thing to get info about the clinical trial, the qualifications for participation, and the FDA marketing approval.
Thanx 4 your learned response,I don’t have years, My neurologist is so conservative ugh. I will try,I will also send an email to the company. And thanx… xoxo N
There might be an other option for you. It is the FDA’s compassionate use process. This requires a life threatening,or major life impacting illness, agreement from your doctor to use it, agreement from the provider of the drug to sell it to you, and inability for you to participate in a clinical trial due to geography, or non-qualification.
It is a WHOLE lot of work for your doctor to do this since he/she has go through his/her IRB, prepare an IRB submiss ion and do lots of follow up reporting. I tried to use this for me, but it fell apart because the provider backed out because any adverse reaction could interfere with FDA approval. That was quite disappointing!
Linda4 I just saw this now… What does IRB stand for?? Thanx xoxo N
Sorry, Neta. IRB stands for internal review boars or institutional review board -I forget which, though I suspect that institutional review board is right. All research projects must be approved by one. They exist in universities, research hospitals, etc. they have the purpose in looking out for human rights in research in rssponse to several research projects like the Tuskegee Experiment and the Milken Experiment, beither of which should have ever happened. They enforce research ethics, and are wonderful in that sense. It is a lot of work for researchers to prepare IRB input and it does take some time-on the order of a couple months, but they really are researchers’ and study participants’ friend.
Currently, the National Ataxia Foundation are using this type of survey to invite people genetically-diagnosed with Spinocerebellar Ataxia to take part in a research study. This specific study, is focused on people aged 18-45, and is to gain SCA Patients perceptions of Genetic Risk and Reproductive options xB
Thanks so much.I have written to the company and sent my neurologist a copy of the newsletter. xoxo N
I’m54. I’m SOL! Maybe next time!
It may be too late for me. But
this looks promising also to treat other forms of neurological conditions (ataxias) as well.
I am going to Johns Hopkins next week for Biohaven expanded study with Trigriluzole (BHV-4157) for one year. They will start with the usual dose of 140mg. But for 2 consecutive visits,if there is any deterioration of SARA score of more than 2 points, with my permission, they can always increase the dose to 200-240 mg. No placebo trials on this one.
Good luck! Please do keep us posted on how it is going.
Me too. What do we do with this information? The only treatment or recommendations he could make was vigorous exercise.
I thought BHV-4157 was to be completed by 1/2/19? I’m confused!
You are right. Phase 2/3 of BHV-4157 study ended in 2018. Although there was no statistical improvement of SARA score noted compared to placebo, further analysis of data did show some halting of progression. That’s why the FDA allowed Biohaven to have an expanded study for one year & increase the dose ( if needed).
Actually this is a different drug trial directed at MSA. I am hopeful that (if successful) its’ use crosses over to treat other diseases. Keeping a watchful eye.
Biohaven (BHVN) Reports FDA Notification of Approval to Proceed with Phase 3 Clinical Trial Of BHV-3241 For Multiple System Atrophy