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The IVIG Study Needs 3 More Participants ASAP


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http://pandasnetwork.org/2011/12/ivig-study-needs-participants-asap/

 

 

It’s crunch time, everyone! We need every parent to step up to the plate and pass the word TODAY about the NIMH IVIG study.

 

PANDAS Network.org received notification that the NIMH needs only 3 more participants then they will be able to do an interim analysis of the progress of the study!

 

We know the determination of this community and the ability to network and communicate. If you know of any new onset cases (6 months into onset or less) and they fit the criteria of the IVIG study, tell them to contact the NIMH TODAY!

 

You do not have to pay to join the study. All travel expenses are covered.

 

CRITERIA REMINDER:

 

New onset cases. This means your child’s onset is 6 months or less at this point in time.

 

INCLUSION CRITERIA as noted on the Clincial Trial page:

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

 

Male and female children 4-12 years of age.Presence of (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision) DSM-IV TR OCD with or without a tic disorder. Moderate or greater severity of symptoms, with a score of greater than or equal to 20 on the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) and greater than or equal to 4 on the Clinical Global Impression Severity scale (CGI-S).

 

*The acute onset within the previous six months of symptoms in a child previously well, or the first acute recurrence within the previous six months, after a period of relatively complete remission of symptoms. The acuity of symptom onset/exacerbation is key and must be severe, dramatic in onset, and proceed from no/minimal symptoms to maximum severity within 24-48 hours.

*Symptom onset or first exacerbation temporally related to GAS infections, as documented by positive throat culture, exposure to documented GAS infection (in a close contact, such as a sibling sharing a bedroom), and/or documented two-fold rise in one or more anti-GAS antibody titers.

*Onset/exacerbation of OCD is accompanied by at least three of the following 7 clinical signs and symptoms. The acuity of the comorbid symptoms must be similar to the OCD symptoms and occur in the same time interval.

 

1.Markedly increased level of anxiety, particularly new onset of separation anxiety.

2.Emotional lability, irritability, aggressive behavior and/or personality change.

3.Sudden difficulties with concentration or learning.

4.Developmental regression (“baby-talk,” temper tantrums; behaviors atypical for actual chronological age).

5.Sleep disorder (insomnia, night terrors, refusal to sleep alone).

6.Handwriting deterioration or other sign of motoric dysfunction (including new onset of motor hyperactivity, or presence of choreiform finger movements).

7.Urinary frequency or increased urge to urinate; daytime or night-time secondary enuresis.

 

All other information can be found on the Clincial Trial Page.http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01281969

 

 

 

If you feel your child fits all criteria and you were dismissed as a possible participant, feel free to contact us at PANDAS Network at pandasnetwork@gmail.com. Tell us when you attempted to enroll, give us a brief history (following the criteria) and we’ll look at it. Again, only if you feel your child filled all the criteria and was passed up.

 

We really need to hit this milestone in the study and we are only 3 participants away from the NIMH being able to a interim analysis if the progress. Let do this!

If you read this post, share it!

 

 

 

Contact(s) for study:

Patient Recruitment and Public Liaison Office

Building 61

10 Cloister Court

Bethesda, Maryland 20892-4754

Toll Free: 1-800-411-1222

TTY: 301-594-9774 (local),1-866-411-1010 (toll free)

Fax: 301-480-9793

 

Electronic Mail:prpl@mail.cc.nih.gov

 

Or contact rachel.kuschner@yale.edu

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