MN-001 Clinical Trial Has Begun!

[icnmgrjill]

(Jill's note - Proof yet again that the IC research frontier is looking good. Here's another new treatment possibility for IC that has been studied extensively for use in asthma. Early studies show that it can help reduce the symptoms of IC. Research centers are located around the USA. Read them now in our clinical trial at: http://www.ic-network.com/clinicaltrials/)

MN-001 Clinical Trial Begins In USA
A new phase II multicenter, placebo-controlled study will evaluate the safety and efficacy of a new oral medication for IC. MN-001 is a novel, anti-inflammatory compound that has been demonstrated to affect many of the downstream mechanisms activated by mast cell degranulation. MN-001 and its primary metabolite MN-002 block leukotriene receptors and inhibit phosphodiesterase IV. Results from early clinical studies have suggested that leukotriene antagonists have positive effects on symptoms of IC. MN-001 may reduce bladder hyper-reactivity much in the same way that is reduces airway hyper-reactivity in models of asthma.

This clinical research study is for adults experiencing chronic bladder and pelvic pain coupled with urinary frequency and urgency. The study term is 8 weeks. The clinical study will evaluate the therapeutic response, safety, and tolerability of an investigational study drug in the treatment of interstitial cystitis and its symptoms.

During the course of the study, two-thirds of participating patients will receive the study drug and one-third will receive placebo. All study participants will receive supervised medical care as it relates to the study. There will be no cost for participation. Research centers are located throughout the USA. Patients diagnosed with IC as well as those who have bladder and pelvic pain, urinary frequency, and urgency are encouraged to call 1-866-652-6938 or to visit Web site www.BladderPainStudy.net to learn more about this clinical research study

[K9wife]

I posted this 5/29 under "Flare coping strategies", but then kinda forgot about it....does it look promising?????

[ICNJess]

Ohhh I hope this works out well, it sounds great!

[Dianne]

Jill, do you know if there's sodium in this drug? I wasn't able to handle singulair, etc. that affect mast cell activity because I can't handle anything with sodium.

[Cheries]

I have severe reactions (bladder) to a lot of meds. What is your resonse to sodium? I am trying to figure out what is in all of these meds that flare me up. Meds include trazadone, elmiron, cymbalta, almost anything flares me up!! Help! Any websites that you know of that could check what is in these meds?

[Dianne]

Any meds. with sodium cause intense burning and pressure both bladder and urethra. That can also mean sodium chloride that the drug is mixed with. Even one drop is too much although table salt in moderation isn't a problem but I'm told that sodium is much stronger than table salt. I couldn't begin to name all the drugs with sodium in them: heparin sodium, sodium chloride, sodium bicarbonate, singulair, many antibiotics, steroids are mixed with NaCl, Uracyst, Cystistat, elmiron (pentosan polysulfate sodium) lidocaine is mixed with NaCl - excepting urojets - the lidocaine gel doesn't have NaCl so I can tolerate that one. I quit trying drugs with sodium since I know I can't tolerate it anyway. I too reacted to Cymbalta but not til the 3rd day. On two retries I reacted the first day each time although no sodium in Cymbalta so no idea on that one.

[Cheries]

Diane thanks for all of your info. You seem to be very sensitive to meds like myself. I am noing to look al of these meds u and see ifthey in fact have sodium as well. What kind of reaction do you get from it? Did ou stay on cymbalta for awhile?

[ICNDonna]

I'd like to participate, but I don't see any Oregon test sites. :(

Donna

[Dianne]

The way I know if the problem is something I just put in my mouth versus ordinary day pain is if the pain/burning/pressure go away after emptying - it's every day pain. If it doesn't go away with emptying and still feels the same - it's something I put in my mouth in the last 1-2 hours and leaves 24 hours after I don't take another one of whatever it is. I never got past the 3rd pill on the Cymbalta. I was just too inflammed to continue. I liked the fact that I couldn't feel any effects of the Cymbalta as opposed to other anti-depressants I tried and it almost wiped out my hot flashes too which was a bonus, but the burning/pressure were too great to continue.

Donna, I'm looking at the Ogden site and will call to see if I qualify but I've always been turned down as too severe in the past. I need to know too if the placebo has sodium in it because I can never tolerate that. Ogden is about 7-8 hours from here. It's 350 miles. If I could get in before winter hits, it might be doable.

[CINDY3]

I need help finding my DR.can anyone out there help me? I have seen 2 letters about Dr. Brookoff because it was explaining why he is no longer with the Methodist. He is suppose to be opening his new practice.Well, they won't tell me anything where he use to be, where I would go for my visits...I NEED TO FIND HIM!!! I have been lost without him, HE IS THE BEST DOCTOR OUT THERE, HE CARES (with his heart) ABOUT ALL OF US 1,000 PATIENTS!!! PLEASE, if anyone out there knows anything please write me and let me know...
THANKS ! ! !

[mela414]

Diane,

dDoes sea salt irritate you? I'm starting to think that I am sodium sensitive as well. It seems to be in a lot of the things that irritate the heck out of me. I'm just not sure anymore.

[Dianne]

I have no idea. Table salt in moderation doesn't bother my bladder although it gives me canker sores but I'm told sodium is way stronger than salt.

[Cheries]

Wish me well everyone. I am going to drive about 3 1/2 hours tomorrow to Corscicana Texas to be a part of the new study MN-001. I am excited to actually participate. I have been involved in other studies before and at least I won't have to have an instillation! I will keep you posted. I hope I don't get the placebo! Unfotunately I have to drive alone up there, but I guess it will make it easier if I have to stop!

[Dianne]

I'm interviewing on Mon. It'll be an 8 hour drive for me. Can you share what all you learned about the trial? Previews! LOL

[Cheries]

I just went today and was very impressed with the study and the criteria. Hopefully everything will work out well and I can participate. I have to go back in one week. It is 3 1/2 hours for me. The staff was wonderful and I feel good knowing that I am helping in a small way to move science forward. Go for it!!

[Dianne]

Just an update. I took the prelim questionaire and passed it. They forwarded to the Ogden site. She EM me on a Fri. 7/29 and asked for times to contact me, said she wanted to interview me early the next week. I gave her all available times. Didn't hear from her all week. I called the main number back and left a msg. saying that. They called me Fri. a.m. (a week after original call from the woman who was to interview me) and asked if Ogden lady had contacted me. No, she hasn't. I told him I didn't think it was very responsible to make appts. with potential candidates and not even keep them. Then he says "well do you want her to still call you?" "Uh, YES, like I wouldn't have applied if I wasn't interested..." He says ok, he will contact her. Never heard from her. I hope this is a valid trial because I haven't been impressed so far.

[Derrick]

I'm driving to Miami next Monday to meet with some doctor down there to see if I'm a fit for the study.

[SandyRN]

I just took the prescreen test and sent it in...after reading Diane's comments I'm not so sure about it anymore. The trial is about 90 minutes or so from my house, but if it helps me, or anyone else out there with IC, I'd be very willing to go. Guess we'll see if I hear anything from them.

Sandy

[Dianne]

I got yet another call from the guy at main center wanting to pre-screen me. I reminded him that I had already done that and reminded him that the site co-ordinator didn't keep her appt., etc. for the next step. I really gave him the whole load of hay this time which he promptly remembered the story and couldn't get me off the phone fast enough. Then I got a very nice email/apology from the site co-ordinator. She said though that anyone on elmiron can't participate without going off it for a couple of months. I'm instilling it, but still probably wouldn't be accepted. She also said the trial lasts 4 months, not 2 months which would put me into winter driving conditions so I don't think I'll be able to do this. I'll be anxious to hear from those that did. Good luck, everyone.

[philly]

I am going for my first visit in Marlton, NJ on Thursday morning. I am told it will take up to 2 hours and will include a fasting blood draw, physical exam (including a vaginal exam) and I'm not sure what else that will add up to 2 hours. I was also told that you have a 1/3 chance of getting a placebo, that the study requires only 4 visits to the study site, and that you get $550 for participation.

I will update after the first visit and let you know how it goes!

Debra

[philly]

I had my first visit last Thursday (8/11), my second of four visits is this Thursday, when I get randomized to one of the treatment groups (500mg vs 1000mg vs placebo). The first visit involved filling out some IC symptom questionnaires, a very brief physical exam by the study urologist, a urine test and a fasting blood draw. The whole thing didn't take much more than an hour. I'm not sure whether I prefer to be in the placebo group or a treatment group!

[donutgirl]

Hi all. I haven't been to the boards in a while...haven't really felt like it, but glad I signed on tonight. I checked the information a week ago, entered my zip code and found out there is a trial being conducted in Winston-Salem, NC, so I completed the survey. The next day I received a phone call and was interviewed over the phone right then (they asked if I had time first). Two days later I got the information packet in the mail. I talked to Dr. Evans, my urologist about it, and I think I'm going to participate if I qualify (see info. below). There are a couple of things you have to do before participating. 1) You have to stop Elmiron 4 mos. BEFORE you can participate 2) You have to stop Atarax I think it is 2 wks BEFORE you participate 3) You can not take these 2 drugs while participating in the 8-9 week study. 4) They "may not" accept me because I have IBS...they said the drug they are testing has gastrointestinal side effects and they want to ensure they are not getting IBS symptoms vs. side effect symptoms. They are going to ask the doctor in charge of the study if I choose to participate. Just wanted you to be a little more informed. OH....the good thing is...if you make it through the full 8 wks, there is a good pay scale for making it. Anyone who wants to email me can do so & I'll try to look at my paperwork to answer your questions.

Diane

[donutgirl]

Also got a phone call from the main number the day after I received my packet to ensure I had gotten it and to ask if I had any questions.

Diane

[Dianne]

I heard back from the test site that this drug does in fact have sodium in it so that eliminated me since I can't tolerate any form of sodium. I'll sure be interested to hear how others are doing on the study.

[philly]

Today I went for visit 2 of 4 for the study. More fasting bloodwork, another EKG, a rectal exam (it's either that or you producing a stool sample - thought the rectal was mildly less gross), and I got my study medication - medium-sized white tablets. Stomach upset is supposed to be a fairly common side effect, so we'll see what happens. I'm still undecided as to whether I'd prefer to be in the placebo group or one of the study groups. That's probably a good thing, since I don't have choice!

I don't have to go back agian for another month, and then another 8 weeks after that. I'll report back her if I think I am having any side effects from the study drug.

For the folks that live in the South Jersey/Philly area, the nurse managing the site in Marlton is very nice. She's funny, and she really makes it as quick and painless as possible to be there.

[SandyRN]

I keep forgetting to call the nurse back down here about the study. Its in Winston Salem (Jen!!) so I have an excuse to go up there now. She told me that from my questioinaire answers I sounded like I was acceptable, but I need to talk to her in more detail.

Gotta make that call tomorrow!

[Derrick]

I got back from Miami late yesterday with the meds. Took my first dose this morning at 8am. So far so good, but I think i got the placebo as i didn't taste pill residue that you can get with some medications.

Anyone notice anything after they took it?

[philly]

I was wondering that myself (if I got the placebo) as I haven't noticed anything (and I get side effects from many things) since I started taking the meds on Saturday. The nurse at my site (Marlton, NJ) said that there is only one other person enrolled in the study thus far, and she started experiencing diarrhea within a day of starting.

Also, Derrick, same experience for me in that the pills are tasteless...I was wondering if that was a placebo thing also. Who knows????

[Derrick]

Any chance we can add MN-001 to the TREATMENTS - Experimental section of the ICN website?

[Derrick]

Hi,

I drove down to Miami, FL and finished the MN-001 clinical trial yesterday.

Haven't seen much in the way of posts, but it appears that this treatment is a complete B-U-S-T.

The doctor and the researcher both told me that out of the 6 that particpated, no one reported any improvement or got worse. They seem to think that it would be unlikely that all six of us got the placebo, but stranger things have been known to happen I guess.

The doctor in charge of the study told me that they are launching another IC clinical trial some time early next year with a new drug that has estrogen as a base. Not clear if males will be able to particpate at this time, but at least they are coming out with another oral medication to try.

Anyone else finished???????????

Derrick

[fayecarole]

I started on a pill Oct 8 and had some side affects. After 8 days I was still having them. They told me to quit taking the pill and when all the side affects were gone to try taking it again to be sure it was the pill causing the affects. I had headache, nausea and anxiety. Don't know if the first two caused the anxiety or not. I am feeling better and am going to try it again. I asked the nurse and she said I was the only one actually taking the pill and she had two more patients ready to start. This is at UAB in Bham, Alabama. Of course I may have the placebo but she said sometimes the placebo could cause side affects.

I would like to hear from anyone else who is in this trial and if they had this problem. Thanks, Carole Williams

[MBB]

I finished the research study earlier this summer and had great results. Within approximately 2 weeks of starting the medication I noticed a huge decrease in my level of pain. It was the first time in a very long time that I started to participate in activities without worrying about getting sick. I was actually very sad when the study was over and have since gone back to having varying levels of pain most every day. I know we all respond differently to medications, and that we can't even say for sure with this study whether we're on the medication or not. I do know that for those two months this summer I felt better than I have in years and I'm very glad that I participated. Just wanted to let you know about my experience with the study.

[mlb]

Call me crazy, but haven't we all read that estrogen and mast cells don't mix?

[philly]

I just finished the study last week. I was pretty sure that I'd been getting the placebo, because I had no side effects whatsoever, no noticeable benefit, and no pill aftertaste....but who knows.

[JaniceB]

So when you complete the study, do they recommend treatment(s) for you?

[philly]

No, they didn't. They just said, "see ya later, good luck, check will be in the mail." The study does not involve a thorough IC/urological evaluation whatsoever, and therefore no treatment recommendations.

[JaniceB]

Hmmmm OK. I'm in the 12-week amitriptilyne study, mainly because I couldnt find a dr willing to help me, and the study nurse said they would, and I was desperate to find something to help. Its helped with my pain, but nothing else, I'm trying to stick it out till the end, just a month away, and hope they really do help me , or maybe my family dr will at that point, since she has been encouraging me to stick with the study.

I've already had pretty much all the IC tests, though, (been to a uro several times) feel like I'm tested out. . plus the pages and pages of questions I've answered that prove I have IC symptoms.

[philly]

if they said they would, hopefully they will help you, but maybe that would be part of a regular visit to them, and not part of the study itself....but I don't know. I wasn't asking for help so maybe that's why I didn't get it...who knows?

[MBB]

Carole,

For about the first week or so of the study I was nauseous and kind of felt like I had the flu. I was thinking that I was going to have to drop out of the study, but stuck with it and the symptoms went away. Hope you have better luck on your second try.

[fayecarole]

I stayed off the pill for a week and started taking it again last Sunday. I took it for two days and had the same results, headache and nausea. I think I was gettting the double dose. They told me 1/3 would get placebo, 1/3 single dose and 1/3 double dose. I have discontinued the pill and have appointment to go back on Nov 4. At the beginning they told me if it did help me that at the end of the eight weeks I would not be able to get any more unless I was selected for the next trial which was a bummer to think about if it had actually helped me. I had no improvements in my bladder symptoms at all but I guess I didn't take enough of it (40 pills altogether, 4 a day for 10 days), eight days consecutively off a week and then another two days. I am so disappointed because even if it didn't help me I thought it might help someone else. faycarole

[Cheries]

I became very sick on the pill after taking just two. I could not take them again. My stomach was excruciating and acid-like. I am sad.
Do you think Singulair would do the same thing because it is similar?

[fayecarole]

What is Singulair?

[mlb]

Singular is an anti-histimine drug.

[purpleviolet]

Hi Singulair is a not exactly anti-histamine - its not hydoxyzine - its a lukotriene inhibitor (I guess lukotrienes are what cause the inflamation in asthma and maybe the bladder.) It didn't really work for me, but I think I don't have an allergy related IC. I felt no side affects from it, though. It was OK to take with hydroxyzine or elavil according to doc and pharmacist.

[icsonja]

Wow, I just read all the posts about the trial, I see mixed results, but I got the feeling that if you were gastro sensitive this was not gonna be a good drug for you (that would include me :( .
I am starting a clinical trial for bion a nuero stim , a tiny matchstick sized device.
But unlike what i saw here, they are covering ALL my medical care for the length of the study, (up to five yrs) and I get to continue treatment with the bion after the 1 yr test is over and they will continue to care for me and it , but no monetary compensation.
I thought there were uniform laws about trials,about you being able to get the med if it worked for you, or is it all individual to the trial?
I was advised to have an attorney look over my consent(by the DR doing the trial) to be sure I understood what was involved. Did you all do that as well?Or did they ask you to?
I am sorry to be so nosy, but trials can be scary and it seems some companies do not look out enough for the patients involved, that scares me.
My attorney approved my consent/contract with a few modifacations, I think it was worth the$75.00 to have it checked out.Mine involves surgery, so life or death is resting on these peoples skill, as with a new Medication.
Did you get some sort of protection in your contract in case of catostrphic results?
Being a guienia pig is scary, but someone has to do it and Ifeel lucky to be chosen, lets hope I feel the same way in a year.
Thank you to all you brave souls who do trials, you are paving the way to our cure.
Heros for sure!!
Sonja

[fayecarole]

I don't remeber the consent form precisely. I have a copy of it somewhere. I do remember it said UAB would pay medical expenses for any complications but since it was experimental medication
they could not vouch for its safety. I just took the chance. Somebody has to if we are ever going to find something that will help this terrible disease. I was also to be paid $550 if I completed the study (four visits) I made three visits and it is my understanding I will be paid $350 at the end of the study. I would have done it for free. I just want a cure or at least something that will help the people suffering from this terroble disease.

They did tell me they were doing a trial on thalodymide(sp) but I am afraid of this with its bad history of birth defects.

faycarole

[angelaharrell]

faycarole,

I begin the clinical trial in January at UAB. I was really debating with myself on if I wanted to go through with it but after I read your posting and you said ever so wisely: "they could not vouch for its safety. I just took the chance. Somebody has to if we are ever going to find something that will help this terrible disease."

I have decided to do it. It's kinda like taking one for the team! But seriously,,,thanks for the posting, you've helped me make what I feel is the right decision.

-Angela

[Silverfox]

Dear Angela,

I would like to learn more about the study you are in at the University of Alabama.

I will send you a pm. My next appointment at the UAB is in Dec.

Best Wishes

[angelaharrell]

Hey Sheila,

Neat, my parents live in Opelika; they just love the area there. I'm in Dothan, not too far from you! Small world!

I'll be happy to talk to you about the study. Today is a bust because I have family on the way here for the Holidays but let's plan on talking right after Thanksgiving.

One of the studies at UAB is dealing with the link between Hormones and IC flares. I mentioned to Dr. Lloyd about how I think my IC is worse when it's "that time of the month". He asked me to consider participating in a study UAB was taking part of. I agreed and he said someone from his office would call me. They've never mentioned paying me for my participation but I'm sure there is some level of reimbursement.

About a week later, a woman name Wil called me from his office. She asked me certain questions to see if I qualified...the questions were...do I have a sodium allergy, antihistamine allergy, and what kind of drugs was I presently taking. She told me to stop taking all of the drugs for at least 3 months before the study. I go on the 24th of January to begin the clinical trial and at that time I will learn more.

I don't have Dr. Lloyds number on hand, but I'm sure that the receptionist at his office would be happy to give you info on the study.

I look forward to speaking with you soon,
Angela

[Mom of Twins]

Well, after talking to my urologist and my husband, I decided to see if I qualified for this MN-001 study. They sent me a packet and said that I prequalified on the phone. I have to go off Elimiron for 4 months.

Well, I went off Elmiron the first week in September, and I am completely suffering with pain. It has gotten so bad the past month. In fact, the past 3 days, it is difficult to walk. And, I am not even able to start the trial until January.

I am wondering if this is worth it for me...I was wondering if the Elmiron even worked for me, but now after being off of it since Sept. and with my pain increasing, it must have been working.

I see my urologist next week, and I will ask him what he thinks--my luck, I will get a placebo, anyway.

Just needed to vent, I guess. I am so tired of being in pain and not living my life the way I want to....

Thanks for reading.... :shake:

[purpleviolet]

Can you go on short term pain pills til then? Can you take pain pills during the trial if you feel bad? PV

[Cheries]

I did the study and got very sick from the meds the first time I took them. They effected my stomach, but I may just have too many stomach problems. I had the placebo the first time around. I do not regret trying it as I learned from it and if it helped me it would have been worth it. I had to travel 4 hours one way to do it and I am sad I wasn't able to complete the study. I don't know what it could have in it that would effect the stomach, but it sure got me. Also, I did figure out how to tell if you get the placebo or not by the way the pills look. Of course I didn't realize this until after I had the placebo and got the real thing.(placebo is very light-weight in comparrison!)

[Mom of Twins]

Purple Violet: Thanks for asking--yes, I am on CONSTANT pain meds--I am taking hydrocodone and it does not completely eliminate the pain, but it is all I can take and still function during the day. But at night, I am so tired and sleepy. I want to go to bed at 8PM, but of course, I can't do that. I understand that I can still take pain meds. I am going for a rescue treatment this morning--I hope that will help.

[purpleviolet]

Andrea - I hope your rescue treatment helped. Is it an instillation?

[Cheries]

How long have you been on hydrocodone? After awhile I no longer got the side-effects of tiredness from it. I am on the duragesic patch and I find it a lot better than hyrocodone for pain as well as side-effects.

[angelaharrell]

I just finished up my clinical trial. No side effects, but no improvement either. Well, I take that back, I did have a slight decrease in frequency, but then again I've quit my job so it's a little hard to tell.

Did everyone that participated get reimbursed? I have yet to be reimbursed for the study.

[fayecarole]

I had to quit the trial after 3 visits. I had terrible headaches and some stomach problems. I quit in November and received a check for $450.00 about a month ago. Angela I tried to send you an answer to your private message but am not sure if it went through. It was about three months before I got my money. I just thought they were waiting until the study was completed I have Wil's email address if you want it to inquire about your compensation. Carole Williams (faycarole)