The biotin trial results are out

[ton]

This data will be presented in an oral session at The 1st Congress of the European Academy of Neurology on Saturday 20th June at 17:30 in Berlin.

Included as:

O1216: Effect of MD1003 (high doses of biotin) in progressive multiple sclerosis: results of a pivotal phase III randomized double blind placebo controlled study

A. Tourbah1, C. Lebrun-Frenay2, G. Edan3, M. Clanet4, A.-C. Papeix5, S. Vukusic6, J. de Seze7, M. Debouverie8, O. Gout9, P. Clavelou10, G. L. Defer11, D. Laplaud12, T. Moreau13, P. Labauge14, B. Brochet15, M. M. F. Sedel16, J. Pelletier17; 1Rheims/France, 2Nice/France, 3Rennes/, 4Toulouse/France, 5Paris/France, 6Lyons/, 7Strasbourg/, 8Nancy/, 9Paris/, 10Clérmont-Ferrand/, 11Caen/, 12Nantes/France, 13Dijon/, 14Montpellier/, 15Bordeaux/, 16medDay Pharmaceuticals, Paris/France, 17Marseilles/

Background/aims
High dose of Biotin, a co-enzyme for acetylCoA carboxylase, a potentially key-enzyme in myelin synthesis, was evaluated over placebo in patients with progressive multiple sclerosis (MS)

Methods or Materials or Case Report
This is a randomized, double-blind, multicenter, placebo-controlled (2:1) trial of oral biotin 300 mg / day in patients with secondary or primary progressive MS with EDSS between 4.5 and 7 and evidence of EDSS progression within the past two years. Treatment duration was 48 weeks. The primary endpoint was the proportion of patients who improved at M9 and confirmed at M12, defined as decreased EDSS (by at least 1 point for EDSS ≤5.5 and .5 point for EDSS ≥6) or improved TW25 of at least 20%. Other endpoints included MSWS, CGI, mean EDSS, % patients with stable or worsened EDSS, SF36, FIS, 9HPT and conventional as well as non-conventional brain MRI

Results
The last patient is scheduled to complete the study January 2015. Baseline characteristics: 154 subjects (41% PPMS and 59% SPMS) from 16 sites across France were randomized; mean age 51.4; mean disease duration 16.6 years; mean EDSS 6.1. The database will be locked by March 2015. Detailed results from primary and other outcomes including MRI will be presented

Conclusion
This trial will evaluate the efficacy of Biotin 300 mg/d in a randomized, placebo-controlled trial. Results will be discussed in the context of future development of high doses of biotin as a novel potential treatment in progressive MS

Disclosure
This study is sponsored by MEDDAY Pharmaceuticals

[NHE]

Could somebody explain this: Mean CGI and SGI scores assessed at month 12 were statistically significantly better in the intervention group compared with the placebo group (p<0.0001 and p=0.0094, respectively).

what are these p numbers and what do they mean based on the article with these numbers?

In statistics, some people incorrectly believe that the P value is the level of significance. However, alpha is the level of significance. Alpha is usually set to 0.05. This represents +/- two standard deviations from the mean in a standard distribution. The region beyond alpha is known as the critical region. A calculated statistic must fall in the critical region in order for the data, i.e., the sample mean, to be considered significant. In effect, < 0.05. Thus, a sample mean falling in 95% of the center area under the standard distribution is not significant while if it's in 2.5% at either end then it's significant. That said, P is the probability of obtaining a sample mean with a given population mean. In general, a lower P value is better. However, nearly all journal articles incorrectly use P values to express the idea that some data is more significant than other data, i.e., P <0.01 vs. P<0.0001 etc. Any P value less than alpha, or < 0.05, is significant.

A good explanation with graphs as visual aids can be found at http://blog.minitab.com/blog/adventures ... statistics

This explanation is also helpful. http://blog.minitab.com/blog/adventures ... t-p-values

[EricDrake]

Thanks for explanation,

I hope they will show us some more concrete numbers tomorrow on the EAN congress.

[DrGeoff]

Could somebody explain this: Mean CGI and SGI scores assessed at month 12 were statistically significantly better in the intervention group compared with the placebo group (p<0.0001 and p=0.0094, respectively).

what are these p numbers and what do they mean based on the article with these numbers?

In statistics, some people incorrectly believe that the P value is the level of significance. However, alpha is the level of significance. Alpha is usually set to 0.05. This represents +/- two standard deviations from the mean in a standard distribution. The region beyond alpha is known as the critical region. A calculated statistic must fall in the critical region in order for the data, i.e., the sample mean, to be considered significant. In effect, < 0.05. Thus, a sample mean falling in 95% of the center area under the standard distribution is not significant while if it's in 2.5% at either end then it's significant. That said, P is the probability of obtaining a sample mean with a given population mean. In general, a lower P value is better. However, nearly all journal articles incorrectly use P values to express the idea that some data is more significant than other data, i.e., P <0.01 vs. P<0.0001 etc. Any P value less than alpha, or < 0.05, is significant.

A good explanation with graphs as visual aids can be found at http://blog.minitab.com/blog/adventures ... statistics

This explanation is also helpful. http://blog.minitab.com/blog/adventures ... t-p-values

The way that I was taught statistics was to assume an Alpha of 0.05, and proceed directly to a p-value of 0.05 or less as being of statistical significance (and to treat anything less than 0.01 as highly significant).
NHE's comment on journal editors misses covering one vital point:
Most editors will not publish anything that does not hit that magic p=0.05 (or less). This takes us into a discussion of Type I and Type II errors - and it is an easy step from there into a discussion of what science really is.. A lot of folk use this as a way to discredit the work of Popper, while missing the point that he regarded the ability to test (or in our terms trial) a hypothesis as being essential.

In the present discussion the real point is:
Do we reject the clinical value of the specified Biotin dose, when it really would work for most people (Type I error), or
Do we accept the clinical value of the specified Biotin dose, when it really would not work for most people (Type II error).

Personally, I have got mine on order.

G

[EricDrake]

So here are some numbers.

http://www.news-medical.net/news/201506 ... rosis.aspx

Anybody nows if we can take a look somewhere at what they shown at this conference exactly? I was looking for it but could not find

[DrGeoff]

You can buy a copy from:
http://ipp.netkey.at/ean/ean2015/index. ... fdd58898b5
or read the abstract again for free.
G

[Simvic]

fyi - Biotin June Press Release
http://www.medday-pharma.com/news-and-events/

[Simvic]

and this
http://www.firstwordpharma.com/node/129 ... z3e6nxFqaz

[CureOrBust]

oooo.... that's a bit of a worry...

Different sources of D-Biotin currently exist for low-dose food supplements or veterinary use. DSM is currently producing the only pharmaceutical grade biotin having a CEP (Certificate of suitability of Monographs of the European Pharmacopoeia) suitable for chronic administration of high doses in patients.

Hopefully its simply marketing hype, or a rubber stamp issue.

DSM's current page on their Biotin.
http://www.dsm.com/markets/foodandbever ... iotin.html

[DrGeoff]

As I read this, DSM are the only source in Europe.
They may be the only manufacturer, but there are at least two sources in the US (PureBulk and Bulk Powders).
Note that MedDay have appointed a Swedish company to handle distribution of MD1003 in Europe.
This suggests that the marketin people have looked at the supply chain.
Geoff

[seeva]

HI FRENDS i appreciate any one kindly help me how can i get pure bulk biotin
regards
seeva

[CureOrBust]

if you get pure bulk biotin, it will come as a powder in bag. You will need to break it up into the correct dose into individual capsules by yourself. Ensure you know how to perform this step before you simply buy a bag of powder, or pre-arrange it with your local compounding pharmacy.

[ElliotB]

Here are two sources that I know of here in the USA. I don't know if they ship internationally:

http://www.bulksupplements.com/pure-bio ... in-b7.html

http://purebulk.com/biotin-pure/

[CureOrBust]

They both ship internationally. I got my Biotin from one of them.

[Music]

I too have ordered from one of the above places.

One question tho, on the website it says to heat your water as "it's not water soluble" when using the pure biotin. Is anyone else doing this when not making up capsules? I was just going to mix the biotin in water and take it.

Thanks!