Re: Update Autism/LDN trial in Isreal

[Guest guest]

Hello everyone

Unfortunately the LDN trial for Autism has been all set in place since 2006 but has not been able to get off of the ground because there were no applicants. Dr. Gluck contacted the doctor in charge to see why it was not off the ground. His reply is below. This is a tremendous shame to loose a precious potential for getting LDN tested for children with Autism. I wonder what else can be done to help this funded trial get off the ground. Any ideas? How about newspaper adds alerting people in Israel or something along that scale?

Quick story about my husband 's nephew with Autism:

Within 10 days my husbands 2 year old Autistic nephew in New Jersey went from making babbling sounds to saying words, playing with his toys rather than lining them up and looking into his parents faces rather then being in his own world thanks to LDN. His sensory issues have also gone away as he used to scream when he needed to go into water, and now they can't get him out of the bath. His physical therapist says it is like he is a normal 2 year old now but with some slight speech delays. LDN can be a savior for many children around the world.

Aletha

------------------------------------------------------------------------------------ (doctor Wilensky's reply to Dr. Gluck)

I don't know why it is listed as not open to recruitment. In fact we tried actively to recruit families in Israel, but with no success. None of the medical professionals I approached referred. Among the parents those who don't believe in alternative type treatments were not interested, and those who were interested either were not willing to suspend adding on any other treatments for five months of the study or they were not willing to wait for the double blind condition and wanted to start right away on the ldn. The bottom line was that after doing all the work to get irb approval nothing came of the study. This was most frustrating for me , but basically I have given up at this point.

Dr. Wilensky

From: dgluck@ Sent: Sunday, March 30, 2008 9:59PM davidvil@ Subject: Jerusalem Institute for Child Development clinical trial (gov identifier: NCT00318162) for autism

Dear Dr. S Wilensky,

Two years ago, the Jerusalem Institute for Child Development announced that a clinical trial (gov identifier: NCT00318162) would study the possibility of using low dose naltrexone (LDN) in the treatment of childhood autism and that you would be the Principal Investigator. Thus far it is still reporting “not yet open for participant recruitment”.

And yet, Dr. Jaquelyn McCandless, a neurologist who has been a pioneer in the use of LDN in ASD, is now averring that over 7,000 families have reported about LDN’s effects and 75% of them are documenting positive results (e.g., “Wow! My child is asking questions now and playing with his siblings!”). It seems a shame that there has been such a prolonged delay in helping test such a clearly useful medication, which has no significant side effects and no toxicity whatsoever at these low dosages.

Do you hold out any hope that the trial will indeed be implemented soon? Can we here in the help in any way?

Sincerely,

Gluck, MD

Hadassah Medical Organization and Jerusalem Institute for Child Development are in phase 1 clinical trials (NCT00318162) for LDN therapy for autism. Same site www.clinicaltrials.gov. This may not be new to everyone as started in May, 2006. I was under the impression no clinical trials were being done for LDN period.

[Guest guest]

TO ALL: It is very sad that this study has not

happened. However, as an autism specialist, I must

say that to tell parents of autistic children that

they cannot use any other intervention for five months

of a study is unrealistic and unwise and was not well

thought out. No one says LDN is a stand alone

treatment for autism, (THERE IS NO STAND ALONE

TREATMENT FOR AUTISM, WHICH IS AN INCREDIBLY

MULTI-FACTORIAL DISORDER WITH MULTI-FACTORIAL

TREATMENTS) and I would not dream of giving a child

LDN without having a strict dietary regime in place,

healing the gut, giving the needed nutrients, and

dealing with toxicity measures. One does not have to

wait until these are all completed to start LDN, but

they should be started and accompany it as needed. If

it were adults that would be another issue, but there

is a window where children are much more responsive

which gets less so as they age. I myself though I

love LDN and have many hundreds of patients on it,

would not ask any parent to forego all other

treatments for LDN or any one treatment, as all of

them are necessary for healing. But no one asked me;

I personally think they SHOULD ask me and re-propose

the study. Jaquelyn McCandless MD

--- Aletha Wittmann <aletha@...> wrote:

> Hello everyone

>

> Unfortunately the LDN trial for Autism has been all

> set in place since 2006 but has not been able to get

> off of the ground because there were no applicants.

> Dr. Gluck contacted the doctor in charge to see why

> it was not off the ground. His reply is below.

> This is a tremendous shame to loose a precious

> potential for getting LDN tested for children with

> Autism. I wonder what else can be done to help

> this funded trial get off the ground. Any ideas?

> How about newspaper adds alerting people in Israel

> or something along that scale?

>

> Quick story about my husband 's nephew with

> Autism:

> Within 10 days my husbands 2 year old Autistic

> nephew in New Jersey went from making babbling

> sounds to saying words, playing with his toys rather

> than lining them up and looking into his parents

> faces rather then being in his own world thanks to

> LDN. His sensory issues have also gone away as he

> used to scream when he needed to go into water, and

> now they can't get him out of the bath. His physical

> therapist says it is like he is a normal 2 year old

> now but with some slight speech delays. LDN can be a

> savior for many children around the world.

>

> Aletha

>

>

--------------------------------------------------------------------------------\

----

>

> (doctor Wilensky's reply to Dr. Gluck)

>

> I don't know why it is listed as not open to

> recruitment. In fact we tried actively to recruit

> families in Israel, but with no success. None of the

> medical professionals I approached referred. Among

> the parents those who don't believe in alternative

> type treatments were not

> interested, and those who were interested either

> were not willing to suspend

> adding on any other treatments for five months of

> the study or they were not

> willing to wait for the double blind condition and

> wanted to start right away

> on the ldn. The bottom line was that after doing all

> the work to get irb approval

> nothing came of the study. This was most frustrating

> for me , but basically I

> have given up at this point.

> Dr. Wilensky

>

>

>

------------------------------------------------------------------------------

>

> From: dgluck@

> Sent: Sunday, March 30, 2008 9:59PM

> davidvil@

> Subject: Jerusalem Institute for Child Development

> clinical trial (gov identifier: NCT00318162) for

> autism

>

>

>

>

> Dear Dr. S Wilensky,

>

>

>

> Two years ago, the Jerusalem Institute for Child

> Development announced that a clinical trial (gov

> identifier: NCT00318162) would study the possibility

> of using low dose

> naltrexone (LDN) in the treatment of childhood

> autism and that you would be the Principal

> Investigator. Thus far it is

> still reporting " not yet open for participant

> recruitment " .

>

>

>

>

> And yet, Dr. Jaquelyn McCandless, a neurologist

> who has been a pioneer in the use of LDN in ASD, is

> now averring that over 7,000 families have

> reported about LDN's effects and 75% of them are

> documenting positive results (e.g., " Wow! My child

> is

> asking questions now and playing with his

> siblings! " ). It seems a shame that there has been

> such a prolonged delay in helping test such a

> clearly

> useful medication, which has no significant side

> effects and no toxicity whatsoever at these low

> dosages.

>

>

>

> Do you hold out any hope that the trial will

> indeed be implemented soon? Can we here in the help

> in any way?

>

>

>

>

> Sincerely,

>

>

>

>

> Gluck, MD

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

> Hadassah Medical Organization and Jerusalem

> Institute for Child

> Development are in phase 1 clinical trials

> (NCT00318162) for LDN

> therapy for autism. Same site

> www.clinicaltrials.gov. This may not

> be new to everyone as started in May, 2006. I was

> under the

> impression no clinical trials were being done for

> LDN period.

>

>

>

> Messages in this topic (1)

[Guest guest]

Have the people who were planning to conduct this trial contact Dr.

McCandless.