What is MS Phase 3 Fingolimod TRANSFORMS?

Category: Others

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Generic name: Fingolimod Clinical Trial

See also: Clinical Trial

NCT00340834 is a completed 12-month double-blind, randomized study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod administered orally once daily versus interferon ß-1a administered IM once weekly in patients with relapsing-remitting MS. Other study ID #CFTY720D2302.

Side effects

Side effects as an overall problem

Side effects as an overall problem
Severity Evaluations
Severe
0
Moderate
1
Mild
5
None
7

Commonly reported side effects and conditions associated with MS Phase 3 Fingolimod TRANSFORMS

Side effect Patients
Elevated blood pressure 1
Hair loss 1
Heart rate low (bradycardia) 1
Low white blood cell count (leukopenia) 1

Why patients stopped taking MS Phase 3 Fingolimod TRANSFORMS

Multiple reasons could be selected

Reason Patients
Other 3
Did not seem to work 2
Course of treatment ended 1
Side effects too severe 1
See all 6 patients who've stopped using MS Phase 3 Fingolimod TRANSFORMS

Duration

Stopped using MS Phase 3 Fingolimod TRANSFORMS

Duration Patients
1 - 6 months 1
6 months - 1 year 2
2 - 5 years 3
Adherence
Adherence Evaluations
Always 12
Usually 1
Sometimes 0
Never taken as prescribed 0
Burden
Burden Evaluations
Very hard to take 0
Somewhat hard to take 1
A little hard to take 0
Not at all hard to take 12
Cost per month
Cost per month Evaluations
$200+ 0
$100-199 1
$50-99 0
$25-49 0
< $25 6
Not specified 6
Last updated:

1 patient evaluation for MS Phase 3 Fingolimod TRANSFORMS

Apr 6, 2010 (Started Aug 20, 2007)

  • Effectiveness
    Major (for multiple sclerosis)
  • Side effects
    Mild
  • Adherence
    Always
  • Burden
    Not at all hard to take
Dosage: 1 Daily
Advice & Tips: I have been on this treatment, which is now being evaluated by the FDA under Fast Track status, for 2.5 years. My MS has been in total remission since the first dose. The trial was unblinded in January and that's when I found out I have been on the .5mg dose all along. I have recently been told that my liver enzymes are slightly elevated and we are monitoring them, but not high enough to mandate stopping treatment. Fingolimod (a.k.a. FTY720) now known as Gilenia, has given me back my life -- and my will to live it! Sounds corny and dramatic, but nonetheless, it's still true.
Cost: < $25 monthly

Dec 22, 2008 (Started Aug 20, 2007)

  • Effectiveness
    Major (for multiple sclerosis)
  • Side effects
    None
  • Adherence
    Always
  • Burden
    Not at all hard to take
Dosage: 1 Daily
Advice & Tips: This medication, when approved by the FDA, will be the first ever pill form of a disease modifying drug for MS. The capsule is tiny and you don't even notice when you swallow it. It's 1/3 the size of my daily vitamin. It has given me back my life. I have not relapsed in 22 months now, where before the study, I was relapsing every 3 months. My EDSS has improved and I no longer have to take any meds to manage any symptoms (for spasticity, fatigue or depression). While all meds have side effects, I have been fortunate enough to be taking this with minimal negative effects. The most negative thing I can say is that I had an increase in head colds and UTIs for the first 6 months, but none since. I hope to stay on it once the study is over.
Cost: < $25 monthly

Sep 14, 2008 (Started Aug 20, 2007)

  • Effectiveness
    Major (for multiple sclerosis)
  • Side effects
    None
  • Adherence
    Always
  • Burden
    Not at all hard to take
Dosage: 1 Daily
Advice & Tips: This medication is sure to hit the market and when it does I hope all MSers experience the dramatic reduction in relapses that I have enjoyed. I have gone from relapsing every 3 months to being 17 months relapse free now. I am entering the extension phase tomorrow (Sept. 15th.2008) and will continue for a year taking Fingolimod, but not knowing the dose. After another year it will change to Open Label where all subjects will know the dose they are on.
Cost: < $25 monthly

  • 1 helpful mark
Last updated:
Showing 1 of 1 patient evaluation for MS Phase 3 Fingolimod TRANSFORMS