I called on the Yale study- but need help

[SSS]

Hi, thank you-

So, before she wanted to do a 5 minute screen with me, to see if we are eligable for a longer screen, I said I have a ? first.

I asked: Is this a HD IVIG, or a low dose? Because it it my understanding that low dose IVIG will increase/not help at all with inflammation, but the HD actually is the IVIG that will decrease inflammation, and my daughter is all about the inflammation.

 

She tried to look it up, said it was 1,000 per killigram? Is this the 1.0 low dose? My understanding (limited!) is HD IVIG is considered 1.5-2.0?

 

She is double checking and calling me back.

Please advise me if you can!

[thereishope]

The total for the study is 2.0 gm/kg total. It's given over a course of two days...so probably 1gm/kg each day.

 

http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01281969

 

Intervention(s) in this Clinical Trial

•Drug: Gamunex Intravenous Immunoglobulin

◦2.0 gm/kg total, IV (in the vein), over 2 days

•Drug: Placebo

◦Normal saline, IV (in the vein), over 2 days

[SSS]

Thank you Vickie :-)

 

Well, just got off the phone, I guess we passed the very short screening, have set up for a longer phone screening tomorrow.

They were very concerned about dates- what I have is a documented case of strep at 2.4 years old- and truthfully, everything did go downhill for us after that (but she was also exposed to strep as an infant, no documentation of this, nor was their a dx of strep as an infant, nor treatment) and they wanted dates for specific OCD symptoms starting after strep.

I certainly had some OCD to talk about--

I guess we will see...not having done and IVIG or steriods before was a plus.

I have no idea of their timeline of when they want to do this.

And, of course, flying my dd5 who has major anxiety clear across the United States for a placebo is a concern for me...

I'll update tomorrow after our 2nd screening.

Sarah &

Samantha 5

Edited January 31, 2011 by S & S

[thereishope]

Well, if by chance she gets the placebo, it does state "Subjects who fail to improve 6 weeks after blinded IVIG/placebo administration (1.0 gm/kg/day of IVIG on two consecutive days; total dose 2.0 gm/kg) will be eligible to receive open-label IVIG."

 

Good luck on the second phone interview!

[SSS]

Yes, the going back and getting a real IVIG is the, selfishly, reason I would do it.

But, wouldn't it be something if this study pans out successfully, and insurance companies would perhaps start covering IVIG?

Sounds like it is based specifically in OCD related to strep only, what with penicillian being the antibiotic they provide afterwards.

They did not ask me anything about tics. Just OCD.

Sarah &

Samantha 5

[EAMom]

Yes, the going back and getting a real IVIG is the, selfishly, reason I would do it.

But, wouldn't it be something if this study pans out successfully, and insurance companies would perhaps start covering IVIG?

Sounds like it is based specifically in OCD related to strep only, what with penicillian being the antibiotic they provide afterwards.

They did not ask me anything about tics. Just OCD.

Sarah &

Samantha 5

 

I think this is actually good...since it seems that IVIG is supposed to work better for OCD (vs. tics). So, it makes sense to do a study which is more likely going to be sucessful and show clear improvement.

[SSS]

UPDATE:

My husband has said No Way to this- he will not put her through a 6 hour plane ride (she's never been on a plane) and the traumatic experience of IVIG for a placebo-

our daughter is extremely anxiety ridden (although it's gotten better on Azith.)

so I understand where he is coming from.

He was clear: NO WAY.

So, I'll let the Yale folk know right away.

Looking into things closer to home, meanwhile, that won't make us flat broke.

[thereishope]

I would ask the screener from the study what the cut off time frame is that your child would no longer be eligible. Ask them to keep her on file. In the unfortunate event things worsen, there's a chance you and your husband may have a change of mind. Leave the lines of communication open with the study people just in case.

 

There is always a chance your child could get better with antibiotics, time, etc. Don't feel just because you pass on the study right now, things can't get better. Stay optimistic!

 

 

UPDATE:

My husband has said No Way to this- he will not put her through a 6 hour plane ride (she's never been on a plane) and the traumatic experience of IVIG for a placebo-

our daughter is extremely anxiety ridden (although it's gotten better on Azith.)

so I understand where he is coming from.

He was clear: NO WAY.

So, I'll let the Yale folk know right away.

Looking into things closer to home, meanwhile, that won't make us flat broke.

[EAMom]

I would ask the screener from the study what the cut off time frame is that your child would no longer be eligible. Ask them to keep her on file. In the unfortunate event things worsen, there's a chance you and your husband may have a change of mind. Leave the lines of communication open with the study people just in case.

 

There is always a chance your child could get better with antibiotics, time, etc. Don't feel just because you pass on the study right now, things can't get better. Stay optimistic!

 

 

UPDATE:

My husband has said No Way to this- he will not put her through a 6 hour plane ride (she's never been on a plane) and the traumatic experience of IVIG for a placebo-

our daughter is extremely anxiety ridden (although it's gotten better on Azith.)

so I understand where he is coming from.

He was clear: NO WAY.

So, I'll let the Yale folk know right away.

Looking into things closer to home, meanwhile, that won't make us flat broke.

 

I agree with Vickie!

 

Plus, she might think a plane ride is lots of fun.

[SSS]

Thank you, everyone---

My husband rarely says: No Way! So when he does, it is serious. I did sit him down and have a talk on the severity of this, what we are dealing with- he is not opposed to IVIG, and would rather pay for it to have it the easiest possible way on Samantha (5) She is tender and fragile (when she is not in a rage/episode) and to fly her all the way out, stay for 2 days, put her through the hospital experience, for placebo, then do it all over again, he can't do it that way.

Although we have seen improvement on our nearing 30 days on Azthiromycin (and our dose gets cut in half after tomorrow) and ibuprofen, we still have real issues here- just can't go on like this- awaiting our CAM test results, should be this week, but in reality, I think we are looking at IVIG.

[EAMom]

Hi Again,

I haven't read all of your posts...I don't know if you've seen this list from our helpful docs list. There are several No. CA docs on it. Also, Amyjoy has some contacts (she's in Sonoma area) in the medical community (works with a group that offers IVIG?) so you might contact her as well http://www.latitudes.org/forums/index.php?showuser=6014

 

Dr. Brock Bernsten - Pediatrician, willing to listen and support whatever recommendations immunologist made including open IVIG order if required. Willing to do additional research but not very familiar with PANDAS

3838 California St.

San Francisco, CA

Phone: (415) 666-1860S

 

Frederick A. Lloyd, M.D. - Has several PANDAs patients, knows Margo Thienemann, listens well, responsive, will provide antibiotics in conjunction with other Dr. recommendation, open to IVIG prescription if recommended by another Dr.

Palo Alto Center

795 El Camino Real

Palo Alto, California 94301

Phone: (650) 853-2992

 

Margo Thienemann MD - Specializes in Forensic Psychiatry, Geriatric Psychiatry, Internal Medicine, Adolescent Psychiatry & Pediatric Psychiatry, Psychiatry.... OCD & Has well over 20 PANDAS Patients

900 Welch Road

Suite 207

Palo Alto CA 94304

Phone mail: 650 324 3241

 

Dr. Frederick Lloyd, Pediatrician - helped with diagnosis, prescribed antibiotics, did a prednisone trial, and IVIG at Lucile Packard.

Palo Alto Medical Foundation, Palo Alto

 

and from JBG50

In San Francisco East Bay, we have seen:

Herb Schrier MD(Psychiatrist) at Childrens Hosp, Oakland. He supported antiobiotics with pediatrician. Has seen several PANDAS children. Recently has 4 more PANDAS cases. Has been very helpful and flexiblewith treatment strategies. Supports IVIG although we do not have referral yet.

 

Katherine Martinez, Psychologist, CBT/ERT. Excellent. Is on leave from practice in Oakland. Was helpful with eating issues.

 

Denice Killingsworth, OT, Walnut Creek. Wonderful with sensory integration/reintegration. Was helpful with eating issues.

 

Marianna Eraklis MD, behavioral pediatrician, in Orinda. Very supportive and knows a little about PANDAS. Just started working with her.

Edited February 1, 2011 by EAMom

[dcmom]

S- I have to say- I agree with your DH. I am happy for the study, and hope it gives us good info. Yet I would not consider putting my child and family through the uncertainty of placebo, and the inconvenience of travelling multiple times. The only reason I would consider is if I didn't have access and funds for IVIG.

 

Just wanted to let you know your DH is not alone in his thinking.....

[SSS]

Thank you-- and EAMom, that was very, very thoughtful of you :-)

 

I started working w/ a SO. CA DAN! Dr. 4 months ago, because I just could not figure out what the heck was going on (my dd5 does not have autism, per say) we have come to PANDAS, and he is the one prescribing the Azith. we've been on- and the ibuprofen. He would write a script for IVIG. He does treat/have PANDAS patients.

Of course, I am going to take this all (CAM results) to my medical insurance people, which is an HMO, but not holding my breath for real help from them. But I'm going to try!

And, I do want to set up a phone consult w/ a 'pandas expert' to get a 2nd opionion.

Yes, the $ just keeps flying out the door, and I thought that might appeal to my husband, but he is adament, and would rather we pay for it, if necessary. I can certainly see his point.