Investigator Initiated Trial for Low Dose Naltrexone

[Guest guest]

Wouldn't we all like to read a headline like that?

Anyone have ideas, leads or tips on where to start on this topic? I

will pursue all leads and report back. This drug works as far as I

can gather from our shared anecdotes, and positive personal

experience for the past month on 2.0 mg. Wed. night I slept 8.5 hours

straight - first time in a DECADE!

Is there any chance to find a medical professional or institution

that might take interest in pursuing an Investigator Initiated Trial

for LDN?

What I have learned from this group discussion is that there is no

money in it for any pharma, so it's got to be the government, a

university or researcher who can provide/find a grant to pursue this.

I plan to start writing to targets, starting with NMSS, to see if

there is any interest. Any leads would help me cover more ground. And

I am sure this is a topic Dr. Bihari has been immersed in, anyone had

that discussion with him? There may be some issue about him not

wanting to do trials himself, but he might be able to point us in the

right direction.

Or am I out of my depth to approach this?

Thank you all for the insights and experience you have shared, I

wouldn't have this treatment that is helping me now w/o your help!

redtruck99@...

[Guest guest]

> Is there any chance to find a medical professional or institution

> that might take interest in pursuing an Investigator Initiated

> Trial for LDN?

I hear that there is alot of monies involved, Infact I recently read

this below on the Goat serum trial site

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The three phases of clinical development

Clinical Phase I involves studies performed on a small group of

healthy volunteers. The purpose initially is to study how the new

product is metabolised in the human body, and then to determine the

dose and dosage interval that will have a positive effect on the

disease without causing unwanted side-effects.

Clinical Phase II involves treating a larger group of patients

(usually 50-200). The purpose is to demonstrate the drug's efficacy

and to confirm its safety. Comparisons are often made with a group

receiving inactive placebo treatment.

Clinical Phase III is sometimes referred to as confirmation studies.

The main goal is to prove that the promising effects seen in Phase II

are also obtained in larger patient groups (usually 100-1,000

people). At Phase III, great importance is also attached to safety

issues, documentation and production preparations.

SEK 500 - 700 million for a successful project

The costs involved in the clinical development of a new drug are

somewhere in the region of SEK 500-700 million for a successful

project.

The average development time is six to seven years from the first

human trials. This includes the time required for reporting and for

the compilation of the documentation necessary to obtain the

permission of the authorities to proceed from one phase to the next.

The probability that a project that has reached clinical Phase I will

reach the market is on average around 20 per cent. This means that a

maximum of one in five projects is successful. For projects that

reach Phase II, the probability of success is higher, or around 30

per cent, and rises to around 70 per cent in Phase III.

Clinical Phase I Clinical Phase II Clinical Phase III

1-1.5 years 1.5-2.5 years 2-4 years

SEK 50-75 million SEK 100-200 million SEK 250-500 million

The sale of a product that successfully reaches the market has to

cover not only its own development costs, but also the costs involved

in projects that are not successful. A pharmaceutical's total

development costs can thus be estimated to total SEK five to ten

billion.