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        New Message Board Archives >> Medications, Treatments, Therapies 2005 >> Zomig Clinical Trial - NECH & Jefferson
        
(Message started by: Magman on Feb 18^th, 2005, 8:57am)

Title: Zomig Clinical Trial - NECH & Jefferson
Post by Magman on Feb 18^th, 2005, 8:57am

Dear Clusterville:

O.U.C.H. received a call from Lori Choyce at the New England Center for Headaches (NECH). They need 16 people for the Zomig trials to get Zomig labeled by the FDA for clusters.

If you are chronic, now in cycle, or expecting a cycle in the next month, contact Lori Choyce, RN at NECH by phone at 203-322-2748.

This study is being held in 3 different locations, Arizona, Texas and Connecticut, but the only one they are enrolling for is Connecticut at the NECH at this time.

Following quoted message as posted on March 16, 2004 on the O.U.C.H-US website. The protocol of this study remains as stated below.

Quote:

Dear OUCH Member,

We are ready to move forward with our cluster headache study, which we are very excited about. As we discussed with you at the last OUCH meeting, zolmitriptan nasal spray may be a very interesting alternative for patients with CH. It is locally absorbed and the migraine studies that have been conducted show it gets into the blood stream in just 2 minutes. We just received FDA and IRB authorization to conduct this study on cluster headache.

Because this is a study that may pursue a new indication for the drug (which matches your needs), this MUST be a placebo-controlled study. This will be a 6-attack study. However, patients will treat just 2 attacks with placebo, and 4 with zolmitriptan (double blind).

This is a study for both episodic and chronic cluster headache sufferers. Certain escape medication will be allowed 30 minutes after study spray administration if there is no relief. Not allowable escape medications will include sumatriptan or any other triptan after use of study medication.

As we said, we are very excited about this study. We think that it may bring help for many CH sufferers. However, we need your help to spread the word about this study, as well as to help us to find participants. CH is not very common; it will take a lot of time for us to complete the study if we were to just include patients from our Center.

During the study, patients will receive the drug and related medical care at no cost. Please contact Lori for any additional information you need, or to discuss logistics. We also appreciate any suggestion you may have.

With best regards,
Marcelo Bigal and Lori Choyce
203-322-2748
The New England Center for Headache

Kind regards,
Dan Bemowski, President
O.U.C.H.

Title: Re: Zomig Clinical Trial - NECH
Post by Lizzie2 on Feb 18^th, 2005, 9:05am

Have you talked to Lori about this lately? Last I was told, both Texas and Arizona were open and testing. Also, Jefferson is a part of the study as well. Our sect is being run by Dr. Alan Stiles. I keep bugging them about getting up and running, but things have been a little slow going getting through IRB on this end.

Title: Re: Zomig Clinical Trial - NECH
Post by Magman on Feb 18^th, 2005, 9:22am

Lori called just last night and requested assistance in filling 16 enrollment slots at NECH.

That is the latest information available.

Thanks,
-dan

Title: Re: Zomig Clinical Trial - NECH
Post by Lizzie2 on Feb 18^th, 2005, 9:44am

OK...so just keep in mind that the Jefferson site is also still considered a location for the study. The contact is Melissa Bloom. Don't have her phone number off the top of my head, but if you call 215-955-2243 and ask for Melissa, then you should be in business.

Title: Re: Zomig Clinical Trial - NECH
Post by E-Double on Feb 18^th, 2005, 1:31pm

I would do it just to seen over there!!!!

TO be honest, zomig worked in the very beginning for me but then did not....so I went to trex...that was 7 months ago...

I have been thinking about trying it again just because of the half life and the stories of people having longer relief....

I just wouldn't want to do this if it would skew data away from our favor.....

Feedback please before I make the call!

Best,

Eric

Title: Re: Zomig Clinical Trial - NECH
Post by Lizzie2 on Feb 18^th, 2005, 2:25pm

E2--
IMHO, you should do it. In clinical research, even if it isn't a success for you, it is still helpful to the overall goal. You never know if you are getting a placebo for them to test the results against. Also, the FDA is more likely to believe a report that at least has some deviation from the norm than a report with 100% success and 0% success for placebo. That's a bit unrealistic.

Ultimately, the goal is to help yourself. If you are interested in trying it again, I say to go for it! I wanted to join the study trial at Jefferson, but they are so behind in getting it going that I wound up simply asking my doc to just prescribe it for me, and I pay my little copay and live happily ever after. Of course, I'm only allowed 6 sprays/month (by the headache center...not by the insurance company...), but I still have my Amerge and my O2.

Amerge has saved my life in a preventative sense when I really need it. Although it is not yet accepted in the headache profession for the longest acting triptans (amerge and frova) to be used in a preventative way instead of as a simple abortive, I think it would sure help a lot of us out! Amerge doesn't work fast enough to abort a CH if I take it when one comes on. However, if I take Amerge at, let's say....5pm or so. Then it prevents clusters though much of the night for me. I have to head them off.

Ahh anyways I digress. If I were in your place, I'd jump in on the study. But ultimately the choice is up to you! :)

L2 :)

Title: Re: Zomig Clinical Trial - NECH
Post by E-Double on Feb 18^th, 2005, 2:35pm

Just left a message.

Now to wait and see!

Thanks

_E ²

Title: Re: Zomig Clinical Trial - NECH
Post by E-Double on Feb 21^st, 2005, 3:53pm

Got the call today.
I'm scheduled to go to NECH on 3/2 @ 10am.....

Will let you all know how it goes.

Best,

Eric

Title: Re: Zomig Clinical Trial - NECH
Post by catlind on Feb 21^st, 2005, 5:08pm

For anyone else wanting to participate, remember that once you go through the trial you can remain a patient of NECH afterward and you will not have to go through the consultation (or pay the resulting fee).

This clinic is very very knowledgeable about clusters, so it is a great opportunity.

Also, the way the placebo works is that you would get say 6 pills - of those 6 one or two would be placebo. You would not be given an entirely placebo trial, the docs there consider that unethical for a cluster patient.

Cat

Title: Re: Zomig Clinical Trial - NECH
Post by E-Double on Feb 21^st, 2005, 5:35pm

on 02/21/05 at 17:08:59, catlind wrote:

Really? wow!!!!
Then I'm even more excited!!!
I really just figured that I'd be taking one for the team!
PF wishes!!
Eric

Title: Re: Zomig Clinical Trial - NECH
Post by purpleydog on Feb 21^st, 2005, 8:36pm

Congrats, E. You got an in! :)

Title: Re: Zomig Clinical Trial - NECH via-USPS
Post by Magman on Feb 23^rd, 2005, 2:08pm

We have just been informed that participation in the Zomig trial is available to sufferers in all geographical areas via mail.

Please contact Lori Choyce, RN, NECH, at 203-322-2748 for details.

Regards,
-dan

Title: Re: Zomig Clinical Trial - NECH via-USPS
Post by catlind on Feb 23^rd, 2005, 10:34pm

Lori asked me to add that you can email her at lc@nech.net anytime, but to call between 8a.m. and 4p.m. EST Mon. - Thurs.

Cat

Title: Re: Zomig Clinical Trial - NECH via-USPS
Post by Mr. Happy on Feb 23^rd, 2005, 11:53pm

on 02/23/05 at 22:34:12, catlind wrote:

Lori asked me to add that you can email her at lc@nech.net anytime, but to call between 8a.m. and 4p.m. EST Mon. - Thurs.
Cat

I'll see your Lori, and raise you one Bigal.
This request by NECH should be filled by noon tomorrow. They've made it so easy, you don't have to get out of your chair.
(I'm hoping somebody besides me(et.al.) realizes how important it is that they'll still contact us. ) 17 people in cycle. 17 subjects. 17. It's hard listening to years worth of agony posts, when all that's needed is 17. By fone or mail. 17. Free, too.

17,
RJ

Title: Re: Zomig Clinical Trial - NECH via-USPS
Post by eyes_afire on Feb 24^th, 2005, 12:09am

Quote:

We have just been informed that participation in the Zomig trial is available to sufferers in all geographical areas via mail.

This is awesome. Even though my 'cycle is wacked' I've been getting popped a couple times a week. Email sent. Only bummer will be surviving the 2 'blanks'. It can be done.

--- Steve

Title: Re: Zomig Clinical Trial - NECH via-USPS
Post by TxBasslady on Feb 25^th, 2005, 1:35am

Email sent.......

Glad to hear that NECH has not given up on us!

Jean

Title: Re: Zomig Clinical Trial - NECH via-USPS
Post by catlind on Feb 26^th, 2005, 12:09am

To the top.

C'mon folks, only 17 people needed from anywhere in the country.

Cat

Title: Re: Zomig Clinical Trial - NECH via-USPS
Post by E-Double on Feb 26^th, 2005, 12:55am

bump

Title: Re: Zomig Clinical Trial - NECH via-USPS
Post by ckelly181 on Feb 27^th, 2005, 11:23am

I would love to participate, but I don't know if I'll get a round this year. Is it wise to sign up "in case?"

If I do get a cycle, it'll probably be sometime in May/June or Sept/Oct.

Thanks!

Chris

Title: Re: Zomig Clinical Trial - NECH via-USPS
Post by catlind on Feb 27^th, 2005, 6:35pm

Chris, either email or call Lori and ask her. You are better off (in my opinion) to go ahead and call just in case, rather than not do anything.

Cat

Title: Re: Zomig Clinical Trial - NECH via-USPS
Post by ckelly181 on Feb 27^th, 2005, 8:00pm

Okay, I sent off an email.

Now I kind of hope I'll never get the suckahs again, which would negate my testing.

A girl can dream...

Chris

Title: Re: Zomig Clinical Trial - NECH via-USPS
Post by catlind on Feb 28^th, 2005, 10:34am

I heard from Lori this morning and she has over 50 emails for participation, as well as the phone calls. It will take her a few days to get through the information.

She asked that anyone still interested please email her at lc@nech.net their information (name, phone, address, episodic, chronic) so that she can add you to a database they are compiling for future studies that will be occuring.

Cat

Title: Re: Zomig Clinical Trial - NECH via-USPS
Post by Bethany1 on Feb 28^th, 2005, 12:49pm

Wow, 50 emails--- I was probably #49--- :-/ Thanks for the update.

Beth

Title: Re: Zomig Clinical Trial - NECH via-USPS
Post by Magman on Feb 28^th, 2005, 2:57pm

Your response has been fantastic! Thank you for taking the time to contact Lori/NECH in the hopes of participating in this study.

Kind regards,
-dan

Title: Re: Zomig Clinical Trial - NECH
Post by Magman on Feb 28^th, 2005, 5:11pm

on 02/18/05 at 09:44:10, Lizzie2 wrote:

Lizzie,
You apparently made great strides at Jefferson by ‘bugging’ them to get the study under way. I just received the following email under direction of Dr. Silberstein.

“Dr. Silberstein wanted me to contact you and make sure you knew that we are, in fact, a participating site in the New England HA Center trial. If you know anybody who is interested in being involved in this study, please ask them to call Dr. Alan Stiles at 215-955-2097 or Raoul Aponte at 215-955-2037. Thank you for your interest in this very important research. We look forward to working with you.”

Kathleen C. Bradley, RN, BSN
Clinical Research Manager
Jefferson Headache Center

If there is anyone in the Jefferson Headache Center area, please feel at ease in contacting them concerning the Zomig trials.

And Lizzie....thanks for all you do!

Kind regards,
Dan

Title: Re: Zomig Clinical Trial - NECH & Jefferson
Post by Lizzie2 on Feb 28^th, 2005, 11:32pm

Dan,

I'm glad to hear this. Rather disappointed that they never contacted me since I've been doing a lot of work gathering people for their studies...not to mention that I worked in research there with Kathy Bradley and others.

But that's irrelevant. I'm just glad they are getting the study going. I guess they don't think I'm a candidate (even though Lori said I was) because I put my name on their list for cluster studies about 5 months ago, and nobody has ever contacted me.

But...I won't get into that!

If anyone has questions about Jefferson or is in the Philadelphia area, just PM me or email me at CarrieHOST@ha-support.com

Hugz,
Lizzie2/Carrie :)

Title: Re: Zomig Clinical Trial - NECH & Jefferson
Post by E-Double on Mar 2^nd, 2005, 5:01pm

I went this morning.
It was a very cool experience!!!!

and.......

I'm now a patient ;;D Have initial visit on 4/18...will be nice to see doctors who know their $hit!!!

YAY!!!

Title: Re: Zomig Clinical Trial - NECH & Jefferson
Post by E-Double on Mar 11^th, 2005, 11:23pm

I just finished with my 3rd "abort".......

This one had to be the 10 mg because it actually worked 10 minutes!! now I feel the nasty a$$ side-effects of damn triptans ....sunburned feeling and feel itchy and like my skin is crawling YUCK!!!!!!

The first one I think was a 5mg....didn't touch the attack yet I felt gross after.....

The second was definitely placebo.......didn't do a thing + no side-effects YET and this is weird, I had my shortest attack in 10 months which was "classic" Came and went as quick as onset....Weird b/c mine usually "taper down"......

I will call back Monday to set up the follow-up........

I don't think this is a med that I want to continue to use but hopefully it has helped some and I know in the long run it will help MANY others and this was pretty much MY main reason for participating.

Good luck all!!

Eric

Title: Re: Zomig Clinical Trial - NECH & Jefferson
Post by catlind on Mar 21^st, 2005, 1:40pm

I'm thrilled to hear there was an overwhelming response :)

Quote:

-----Original Message-----
From: Lori L Choyce
Sent: Monday, March 21, 2005 10:47 AM
To: Cathy Lind
Subject: Cluster study

Cat,

Can you please forward this email for me. I have had an overwhelming response to our request, Thank you to all who responded. At this time we have only 15 openings at our site for subjects. Due to a hand fracture I have occured, I am behind and still am reviewing the requests. We have written to the governing regulatory body and we are trying to get more spots in the study. We appreciate your patience while we undergo this process and my healing (I am worthless using my left hand!).

Lori

Title: Re: Zomig Clinical Trial - NECH & Jefferson
Post by catlind on Mar 30^th, 2005, 10:44am

Just wanted to update everyone and let them know that the responses are still being worked on. Lori had an injury to her hand and will be going in for surgery next week so she will be unable to do anything further with the study until she returns, approximately the 18th of April.

Cat