My Clinical Trial-Milnacipran for pain-IT'S WORKING

Discussion in 'Fibromyalgia Main Forum' started by IndianPrincess, Aug 19, 2006.

  1. IndianPrincess

    IndianPrincess New Member

    I am participating in a double-blind placebo study of Milnacipran for pain and fatigue in Fibromyalgia.

    In 2004, I also was involved in a double-blind placebo study for Xyrem. During that study I was the only person participating at the Middleburg Heights location who, not only showed NO IMPROVEMENT but my pain and sleep got WORSE.

    At the end of this study, we found out that I was on placebo.

    However, since I don't respond to placebo-effect I believe I am taking the actual meds in the Milnacipran study.

    My elbows, hips, and knees have been the most bothersome for me regarding pain. That pain that woke me, prevented me from lifting and holding something as light as a sauce pan is GONE!

    The article below appeared on this website in 2002. The pharmaceutical company involve in the study I am doing is Forest Industries.

    Milnacipran is widely used in Europe. Forest Industries is seeking FDA approval here in the states.

    READ ON!

    Cindy

    P.S. - The Milnacipran clinical trial info is accessable from this site. Click on Clinical Trials, scroll down to Fibromyalgia section then click. This study is the fifth one down on the list.


    Milnacipran Significantly Improves Pain and Fatigue in Fibromyalgia Syndrome Patients
    Fibromyalgiasupport.com

    12-13-2002

    Cypress Bioscience Inc.'s Milnacipran Significantly Improves Pain and Fatigue in Fibromyalgia Syndrome Patients.
    Milnacipran, Cypress Bioscience Inc.'s (NASDAQ:CYPB) drug currently being evaluated for treatment of the Fibromyalgia Syndrome (FMS) was shown to provide statistically significant improvement of pain and fatigue symptoms in a preliminary analysis of the Company's Phase II clinical trial.

    This trial is the first to evaluate milnacipran as a potential treatment for FMS.

    FMS is a chronic pain syndrome that is estimated to affect 2-4% of the general population. The symptoms of FMS can be debilitating, and are characterized by chronic and widespread pain throughout the body, often accompanied by severe fatigue and poor sleep. Treatment options are limited as there are no drugs specifically approved by the U.S. Food and Drug Administration for the treatment of FMS.

    A preliminary analysis of the randomized, double blind, placebo-controlled, flexible dose escalation mono-therapy trial was conducted on 95 patients, or 76% of the total patients enrolled in the trial, who had completed the trial as of Oct. 31, 2002. A total of 125 patients are enrolled in the trial - the remaining 30 patients have recently completed the study. Patients were randomized to receive placebo or milnacipran (either once or twice per day) for four weeks of dose escalation, followed by eight weeks of constant dose.

    The study evaluated the efficacy and safety of milnacipran for the treatment of pain and associated symptoms such as fatigue, depressed mood and sleep. Patients were asked to characterize their pain, fatigue, sleep and related symptoms several times each day on an electronic diary.

    Milnacipran-treated patients randomized to the twice a day dosing group (BID) showed statistically significant improvements in pain compared to those who received placebo. Of the 95 patients that had completed the trial as of the date of this analysis, 87 percent of all milnacipran-treated patients reported overall improvement, compared to 33 percent in the placebo group (p less than 0.001). Further, 36 percent of milnacipran BID-treated patients reported at least a 50 percent reduction in pain intensity, compared to 9 percent of patients who received placebo, a difference that was statistically significant (p=0.030, intent to treat analysis). In addition, milnacipran-treated patients showed significant improvements in fatigue and depressed mood.

    "It is extraordinary to see such a significant improvement in symptoms in this patient population," said Dr. Daniel Clauw, Professor of Medicine, Division of Rheumatology; director, Center for Advancement of Clinical Research; and director, Chronic Pain and Fatigue Research Center, The University of Michigan and chairman of Cypress' Rheumatology Advisory Board.

    "Attempts to treat the complex pain of FMS with existing medications have met with limited success," noted Jay D. Kranzler, MD, PhD, chairman of the board and chief executive officer of Cypress Bioscience Inc. "Milnacipran, a novel dual-acting reuptake inhibitor that acts on two key neurotransmitters in the human body, norepinephrine and serotonin, which are involved with the central modulation and processing of chronic pain, is distinguished from other dual reuptake inhibitors by its preference for norepinephrine reuptake inhibition over serotonin reuptake inhibition. Based on these preliminary results, milnacipran appears to have the potential to relieve several of the symptoms associated with FMS, and perhaps other related Functional Somatic Syndromes."

    Eighty-four percent of all milnacipran patients escalated to the highest dose with no tolerability issues. The most common dose-related side effect reported by patients was nausea, particularly early in the study. Most adverse events were mild to moderate in intensity, and transient in duration.

    A final analysis of the trial, including all enrolled patients, will be available early in 2003. It should be noted that response rates and significance levels may change when the final analysis is performed.

    About Cypress Bioscience Inc.

    Cypress is committed to be the innovator and commercial leader in providing products for the diagnosis and treatment of patients with Functional Somatic Syndromes, such as Fibromyalgia Syndrome, or FMS, and other related chronic pain and central nervous system disorders. In August 2001, Cypress licensed from Pierre Fabre Medicament its first product for clinical development, milnacipran. Milnacipran, the first of a new class of agents known as NSRI's, or Norepinephrine Serotonin Reuptake Inhibitors, shares a pharmacological profile with the tricyclic antidepressants (TCAs), considered the most effective drugs for treatment of FMS, while appearing to lack the side effects associated with the latter. Cypress recently completed a Phase II trial in which milnacipran is being evaluated as a potential treatment for FMS. For more information about Cypress, please visit the company's Web site at. For more information about FMS, please visit www.FMSresource.com.

    This press release, as well as Cypress' SEC filings and Web site at http://www.cypressbio.com, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements about the potential of milnacipran to treat FMS. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress Annual Report on Form 10-K and any subsequent SEC filings. In addition, there is the risk that the final results from the Phase II trail of milnacipran will be significantly different than the preliminary analysis, that we may not be able to successfully develop or market milnacipran or any other products for the treatment of FMS; that our clinical development plan or timeline for milnacipran may be delayed, including the final results of our Phase II clinical trial; that our current working capital will not allow us to execute our business plans into 2003; that we may encounter regulatory or other difficulties in the development of milnacipran for FMS; and that milnacipran may not significantly improve the treatment of FMS. Cypress undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.



    [This Message was Edited on 08/19/2006]
  2. 69mach1

    69mach1 New Member

    did you have any weight gain or puffiness or any other side effects?

    thank you

    jodie
  3. IndianPrincess

    IndianPrincess New Member

    So far it is difficult to monitor the side effects because I had trouble with dizziness and IBS anyway so I think it is still the Fibro talking and not a reaction. The dizziness has been less for me.

    My Fibro Fog is clearing.

    As far as weight gain, not so far. It is early in the study for me, but I am changing my eating habits and have lost a few pounds. I have eliminated sugared beverages and the weight is dropping. Also my snacks are cheese and crackers, salads, veggies and fruit. No more chips and candy bars.

    Also, I did a Google search on this med. From what I found, I get the impression Milnacipran is available in the states BUT doesn't have the FDA approval for the pharmaceutical company to state that it is a pain reliever for Fibro. That's what the study is about-does it relieve Fibro pain!

    I am sleeping considerably better!

    Cindy




  4. blondie45

    blondie45 New Member

    This is great to read. How many times a day do you take it? At this point though I suppose you have no idea though the total milligrams you are taking a day. Would love to know that when you find out. I see lots of websites say max dose of 100 mg a day to treat depression, but I thought I read somewhere that some of the trials for fibro were 200 mg a day. Do you have any idea?

    Also, do you remember how many days or weeks you were on it before you started noticing you were feeling better?
    [This Message was Edited on 08/20/2006]
  5. IndianPrincess

    IndianPrincess New Member

    I started taking the study drug Wednesday, August 16 starting with the evening dose. I took the evening dose ONLY for three nights. On the 19th, I started the morning dose and have been taking it twice a day since.

    For a month prior I stopped taking Wellbutrin SR, Visteril for anxiety and sleep and Volterin for pain. I could take no aspirin or ibuprophen during this wash period also.

    I noticed feeling better Saturday August 19th. The pain doesn't stay gone all day. It will come back but no where like it was. I can hold onto objects longer but still lose my grip but not from pain!

    The pharmaceutical company also provided a care package of snacks - pretzels, cookies, saltines to make sure that the meds are taken with food. The saltines are for nausea which is a side effect of the drug. For me this is minimal and I don't feel it is a side effect since I often experienced this prior to the study with the IBS.

    The company also provided a large container of TUMS and Pepto Bismol. Haven't needed them yet.

    Acetaminiphen (500 mg tablets) were also provided. I took two today to hold me over till this evening but I did it as a preventative precaution since I was going to have an active day away from home today. I was not in pain when I took the pills.

    In the morning, followed by random prompts throughout the day and a final prompt at 8 p.m. I answer one question on a Palm Pilot asking me to rate my pain. However, with the final prompt I have an additional question rating the average pain experienced in a 24 hour period.

    Occassionally, there is a question about my fatiguewhich is not as severe as before. Over the last two days I am not falling asleep on the bus.

    Please note, and I guess I did not explain this, I am free of Fibro pain. I have degenerative discs in my back and neck and the drug has not eleviated that pain.

    Now, I filled for SSDI two years ago and am in appeal to go before a judge. Since I don't know if this drug is available in the state or if Medicaid will cover it. I am proceeding with my regular doctors as if I have the pain, fatigue and brain fog.

    I am truthful in my report to the researchers. They would not have accepted me in the study if they knew that I had a disability determination pending. But that is just that particular lab.

    The researchers in Middleburg Heights, Ohio know my disability is pending and they wanted me to do the study with them.

    It pays too little to travel by buses (with all the connections) to go 25 miles for $40 per office visit.

    Cindy
  6. Hootie1

    Hootie1 New Member

    The study sounds very interesting. Keep us posted.

    Isn't it interesting that while disability is pending we are concerned about getting better? What a shame. I struggle with that myself.
  7. blondie45

    blondie45 New Member

    Thanks for your information. As far as I know milcipracin is not yet available in the states. From what I have read looks to me like possibly another 2 years possibly.
  8. sueliza

    sueliza New Member

    Cindy,

    Good luck with the study - it sounds like you are tolerating the medicine well!

    I was signed up for this study and got to the day I would have received the medication and I was bumped out because of the way I filled out the impact questionaire.

    That is what I get for being so stubborn! :) When it asked about what pain had kept me from doing over the course of a week I put very low numbers. In my mind if I somehow accomplished the task then pain did not affect me - wrong answer!!

    Please keep us informed about how you are doing.

    Someone said that this medicine is not yet available in the US and that was also my understanding. When it is approved by the FDA it will be the first medication approved specifically for the treatment of Fibro.

    All of our other medications are prescribed off label.

    Good luck,

    Sue
  9. PatsyK

    PatsyK New Member

    DEAR INDIAN PRINCESS> I HAVE SOME MILNACIPRIN I GOT FROM ANTI AGING SITE> ARE YOU ALLOWED ANY SLEEP MEDS> I HAVE TRIED CYMBALTA AND COULD NOT SLEEP WITHOUT TRAZODONE> I LIVE IN A REMOTE AREA AND THE DRS> HERE SAY FIBRO IS ALL IN MY HEAD> YEAH FOR TWENTY SIX YEARS>
  10. IndianPrincess

    IndianPrincess New Member

    HI!

    I had to drop out of the study due to atrial fibulation.

    This is listed as one of the side effects of the drug and we don't know yet if the drug was the actual cause.

    I was stressed and hurried to catch the bus to get to an eye appointment and had a bad spell. My heart started racing and I could see the beating of my chest. I got very lightheaded, nauseous and disoriented.

    I ended up in the ER with a heart rate of 156 and my blood pressure was near stroke level. I spent two days in the hospital and came home with a cardiac event monitor which I wore for one months to record any spells I had. I turned this in two months ago and we are waiting for the results from the lab.

    Despite this, I highly recommend this drug for pain and sleep. My pain level dropped dramatically while on this trial, my sleep improved as did my focus and concentration.

    What I want to know from you is how did you get this drug without a script?

    Do not take any sleep meds or other antidepressants with this drug unless your doctor approves!

    Also, where do you live? Perhaps someone on this board can recommend a doctor to you!

    Cindy