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New Fibromyalgia Drug Trial Recruiting More Than 1,100 Subjects at 124 Locations in US and Canada

  [ 122 votes ]   [ 7 Comments ] • June 10, 2008

A major new trial of the drug reboxetine for Fibromyalgia pain and fatigue is now recruiting subjects at 124 locations in the US and Canada. [Note: Owing to the large number of study locations, trial organizers are now routing enquiries through a central 800 number. See "Important Contact Information" in footnote.]

The Phase III safety & efficacy study - titled “A 14-Week, Multi-Center Study of [S,S]-Reboxetine in Patients with Fibromyalgia” – is sponsored by Pfizer.

With a target enrollment of some 1,148 subjects, the trial will involve four arms – 3 different doses of reboxetine and placebo (fake) dose.

Reboxetine, which is an antidepressant also used in treatment of ADD/ADHD and panic disorder in Europe but not prescribed in the US, is a norepinephrine reuptake inhibitor (NRI). It acts by blocking the reuptake of the neurotransmitter norepinephrine (maintaining higher levels).

As part of the trial, participants (diagnosed with Fibromyalgia and over age 18) will receive: free study related medication and procedures, physical exams and lab tests, monitoring and evaluation, and financial compensation for participation & travel.

For more information on this study ( ID number NCT00612170) - and to review the study locations see the listing at

* * * *

Important Contact Information: Enquiries about the 124 study locations are being routed through a central 800 number. To get contact information for the study location nearest you, use the Pfizer Call Center for the study (1-800-718-1021). The service will ask you to leave a message with:

  • Your name
  • A phone number where you can be reached
  • Your city, state, and zip code.
  • The study ID number (NCT00612170)
  • Its title "A 14-week, multi-center study of [S,S]-Reboxetine in patients with fibromyalgia."

The service promises to get back to you "within 2 business days."

This information has not been evaluated by the FDA. It is not meant to prevent, diagnose, treat or cure any illness, condition, or disease. It is very important that you make no change in your healthcare plan or health support regimen without researching and discussing it in collaboration with your professional healthcare team.

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Article Comments Post a Comment

new single drug for "treatment"of FM
Posted by: barbarap
Jun 25, 2008
Given the multifactorial nature of FM/CFS, I don't see how 1 medication can do anything but act as a Band-Aid.
Reply Reply

Fatigue worse than pain
Posted by: suemorr
Jun 25, 2008
I'm just glad that they're trying to find something new that will help. I really wish for something for the fatigue. The pain doesn't bother me half as much as the fatigue does. And the fibro fog makes it difficult to learn new things.
Reply Reply

New Drug trial
Posted by: wattzdad
Jun 26, 2008
Another antidepressant. I see the government has approved cymbalta for treatment of FMS. I've been taking 60 mg of Cymbalta once a day since it came out in 2004 for the treatment of depression. Before that I took Lexapro. After taking the Cymbalta for 4 months and a reoccurance of some of the worst symptoms of depression, I asked my GP if I could try taking Lexapro along with the Cymbalta. After some research he ok'd it and together the meds have kept a lid on things. I have not seen any reduction in FMS symptoms at all during this time. If anything it's gotten worse. Dan Matthews
Reply Reply

Posted by: ccurdncr
Jul 2, 2008
I just finished this 14 week study and can't wait to start the open label study of Reboxetine. It didn't help my pain as much as it totally did away with my fatigue and gave me so much motivation to get up and go. I love this drug and I hope it passes the tests for FDA is terrific! Cheryl
Reply Reply

Cheryl it helped that much?
Posted by: hensue
Jul 14, 2008
It did not help your pain? What if any are the side affects? when do you think it will go on market? thanks Sue


Posted by: froggyv
May 17, 2011
I was on a drug trial for this medication. The first phase was "blind" however, I knew fairly quickly I was on live drug (I have a very low tolerance). I was approved for phase 2 which was live drug. It felt like a miracle "cure" for me. My pain decreased significantly, my energy level was up, I was losing a little weight (probably because I could exercise again) and I was sleeping!!! I was devastated to learn that it was not available in the US. I did order on line for a time, but soon found it to be back ordered for weeks and weeks on most on-line pharmacies (plus you risk fraud with the drug). I keep watching and praying that the FDA will see the benefit and get approval out there.
Reply Reply

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