Junior Member
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Join Date: Aug 2006
Posts: 43
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Junior Member
Join Date: Aug 2006
Posts: 43
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Paula -
I found this in my Informed Consent:
If it is determined at the conclusion of this study that it is appropriate to provide CERE-120 to people with Parkinson's disease, those assigned to the sham surgery group may be permitted to enroll into an open-label follow-up study in which CERE-120 will be given"
The Questionnaire has this:
After the study is completed, you will be informed about which groiup (active treatment with Cere- 120 or sham surgery) you were assigned. If you were assigned to the sham surgery group, are you aware that you will
have the option to receive active treatment with CERE-120? Yes/No
I sent the coordinator the following:
" Someone asked me about the option of having the surgery - did that end with the completion of phase 2 or does it carry over to phase ?
Her reply:
"...I have not heard anything regarding a possible phase 3. I was told the last time I inquired that they were still in discussions as to what and if there
would be a next step even with the sham group".
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