The purpose of this study is to determine whether CERE-120 is a safe and effective treatment for people with Parkinson’s disease (PD). http://www.ceregene.com/

CERE-120 is a gene transfer agent comprised of an adeno-associated virus (AAV2) carrying the gene for neurturin (NTN). NTN is a naturally occurring protein very similar to GDNF (Glial Derived Neurotrophic Factor) , whose role is to improve the health and function of degenerating dopamine-secreting neurons and to keep them alive and functioning normally. CERE-120 is administered during a neurosurgical procedure to the nigrostriatal region of the brain by bilateral stereotactic injections. This region, rich in dopamine-secreting neurons, degenerates in PD and this degeneration has been linked to the major motor deficits that characterize the disease.

The design of the study calls for approximately 34 participants to receive CERE-120 and approximately 17 participants to receive sham surgery (i.e., no CERE-120 will be administered). Neither the patient nor the patient’s neurologist will know whether treatment or sham surgery was given (i.e., this is a ‘double-blind trial design’). PD study assessment tests and safety tests will be performed on all participants throughout the course of the study. Participants in the trial will be followed for one year after the neurosurgical procedure. At the end of the study, the results from the two groups will be compared to determine if CERE-120 is a safe and effective treatment for PD. If at the end of the study, CERE-120 is shown to be safe and effective, the people who received the sham surgery will be offered treatment with CERE-120, as long as their neurologist and neurosurgeon deem them suitable for the surgical procedure. Less than half of the participants enrolled in this trial will undergo brain imaging by Positron Emission Tomography (PET) twice during the trial.

http://www.pdtrials.org/front/trial_...p?trial_id=128

Tena, thanks for posting this information. I am bumping the prior post by including the following information.

Perry Cohen and I are both possible candidates for the trial that is based in Philadelphia.

Cross posted from http://neurotalk.psychcentral.com/sh...light=ceregene

PDTrials.org
Study of CERE-120 in People with Parkinson’s Disease
Official Study Title: Randomized, Double-Blind, Sham Surgery-Controlled Study of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) to Assess the Efficacy and Safety of Bilateral Intraputaminal (IPu) Delivery in Subjects with Idiopathic Parkinson’s Disease
http://www.pdtrials.org/front/trial_...p?trial_id=128


ClinicalTrials.gov
Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 For Efficacy and Safety in Subjects With Idiopathic Parkinson's Disease
This study is currently recruiting patients.
Verified by Ceregene March 2007
http://clinicaltrials.gov/show/NCT00400634


Recombinate DNA Advisory Committee
Meeting Minutes
September 2006
http://www4.od.nih.gov/oba/RAC/minut...utes_09-06.pdf



PowerPoint Presentation
CERE-120 (AAV-Neurturin) for Parkinson’s Disease
NIH OBA Protocol # 0501-689
A Phase I, Open-Label Study of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN] to Assess the Safety and Tolerability of Intrastriatal Delivery to Subjects with Idiopathic Parkinson's Disease
http://www.webconferences.com/nihoba...des16Mar05.pdf

Just a reminder - neurturin (NTN) is a neurotrophic factor in the same family as GDNF. Amgen has denied us its synthetic gdnf - to our great anger & disappointment. But NTN may prove to work as well as GDNF. Time - and clinical trials - will tell.

Thanks to all the folks who are in clinical trials or considering joining one! It's easy to find an excuse not to join one - and many people talk about the importance of clinical trials but never join one. It takes courage and time and energy and effort to take part in clinical trials. I salute those of you who do!

Slide presentation...see page 9 thru 13
http://www.webconferences.com/nihoba...ar%20Final.pdf


Molecular Therapy
http://www.nature.com/mt/journal/v15.../6300010a.html
This links to the abstract.
See "Full Text" on the right.


Ceregene, Inc. Announces Promising Phase 1 Results From Gene Therapy Trial For Parkinson's Disease
http://www.biospace.com/news_story.a...D=32623&full=1


Ceregene Presents Long Term Follow-Up Data From Phase 1 Trial of CERE-120 Demonstrating Improved Motor Function in Parkinson's Patients
http://biz.yahoo.com/prnews/070416/sfm077.html?.v=87


All articles posted to the BioSpace website:
http://www.biospace.com/news_company...mpanyID=366304

this is very very encouraging!!!
thank you~ dear carolyn and jeanb!

Tena, I had a very nice train ride today, and did attend a Q&A in Philadelphia about the trial...around a conference table with the Investigational neurologist, in a non-clinical setting...slide presentation and all the questions I, and the other patient, could think to ask.

CERE-120 [Adeno-Associated. Virus (AAV2)-Neurturin (NTN)]
With the exception of GDNF, I personally believe this is the most promising therapy to come down the pipeline EVER. It may be light years before something of the magnitude comes along. It is similar to GDNF, and is synthetic.

It surprises me that no one has moved this thread into discussion-mode.

apr0114.gif

I had the great honor of meeting Dr. Greg Gerhart, he went to meet
President Clinton with Congressman Lane Evans.
I went to the University of Kentucky, and was so thrilled that the rhesus
monkeys, went from bad to great, loved Dr. Gregs video -
rhesus monkeys eating lil marshmallows slow, then after the gdnf, the monkeys could not only eat them fast but with both hands,
that was in 2000 -2001 -went to the Parkinson's Gala with Jo Rosen,
and her husband -who has latter stage PD now, such a lovely man and very witty!
I was able to see and had such hope for Dr. Leveques autologus stem cells,
actually introduced Dr. Leveque and Dr. Gerhart, and then all was looking so good,
then it all crashed, doors that were open -slammed shut, and after
all our hard work we all felt the let down and a smack in the face by Amgen...
So God Bless you, for being brave, it aint easy being a patient
and a drug trial like this -seems it would have similiar anti -apoptosis
effects...


take care dear carolyn!
you I will add to my heart prayers as are everyone I know with PD, MS, Cancer, some illnesses without names...have peace overflowing in your spirit.

This is going to be a major trial, lots of hope. time, money, and lives being invested in its success. They are fast tracking with careful results, collecting good data, the lead researcher wears a smile.

Positive thoughts, action, and team spirit go out to the participants.

paula

If this is the path you choose to take - love & best wishes to you! If you choose to participate in this clinical trial, you will help all people with PD! (We need more people like you.. )