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Novartis Study To Compare New MS Pill To Biogen's Avonex
Wednesday September 13rd, 2006 / 23h15


By Anita Greil
Of DOW JONES NEWSWIRES
ZURICH -(Dow Jones)- Swiss drugmaker Novartis AG (NVS) said Wednesday it has initiated a late stage study that is comparing its experimental Multiple Sclerosis pill against Biogen Idec Inc.'s (BIIB) Avonex, an older treatment that needs to be injected.
Novartis, based in Basel, said that more than 1,000 patients will be participating in the trial. They will be divided into equal numbers and will be randomly assigned to receive either the Novartis pill, dubbed FTY720, at a dose of 1.25 milligrams or 0.5 milligram of Avonex.

http://healthology.sparklist.com/t/9...579/2724850/0/

Here's a similar link to see if you qualify for the Clabradine Phase three oral trial.

Here's the New England Journal abstract:

http://www.ncbi.nlm.nih.gov/entrez/q...=pubmed_DocSum


N Engl J Med. 2006 Sep 14;355(11):1124-40. Links
Oral fingolimod (FTY720) for relapsing multiple sclerosis.Kappos L, Antel J, Comi G, Montalban X, O'Connor P, Polman CH, Haas T, Korn AA, Karlsson G, Radue EW; FTY720 D2201 Study Group.
Department of Neurology, University Hospital, Basel, Switzerland. lkappos@uhbs.ch

BACKGROUND: Fingolimod (FTY720) is a new oral immunomodulating agent under evaluation for the treatment of relapsing multiple sclerosis. METHODS: We randomly assigned 281 patients to receive oral fingolimod, at a dose of 1.25 mg or 5.0 mg, or a placebo once daily, and we followed these patients for 6 months with magnetic resonance imaging (MRI) and clinical evaluations (core study, months 0 to 6). The primary end point was the total number of gadolinium-enhanced lesions recorded on T(1)-weighted MRI at monthly intervals for 6 months. In an extension study in which the investigators and patients remained unaware of the dose assignments (months 7 to 12), patients who received placebo underwent randomization again to one of the fingolimod doses. RESULTS: A total of 255 patients completed the core study. The median total number of gadolinium-enhanced lesions on MRI was lower with 1.25 mg of fingolimod (1 lesion, P<0.001) and 5.0 mg of fingolimod (3 lesions, P=0.006) than with placebo (5 lesions). The annualized relapse rate was 0.77 in the placebo group, as compared with 0.35 in the group given 1.25 mg of fingolimod (P=0.009) and 0.36 in the group given 5.0 mg of fingolimod (P=0.01). For the 227 patients who completed the extension study, the number of gadolinium-enhanced lesions and relapse rates remained low in the groups that received continuous fingolimod, and both measures decreased in patients who switched from placebo to fingolimod. Adverse events included nasopharyngitis, dyspnea, headache, diarrhea, and nausea. Clinically asymptomatic elevations of alanine aminotransferase levels were more frequent with fingolimod (10 to 12%, vs. 1% in the placebo group). One case of the posterior reversible encephalopathy syndrome occurred in the 5.0-mg group. Fingolimod was also associated with an initial reduction in the heart rate and a modest decrease in the forced expiratory volume in 1 second. CONCLUSIONS: In this proof-of-concept study, fingolimod reduced the number of lesions detected on MRI and clinical disease activity in patients with multiple sclerosis. Evaluation in larger, longer-term studies is warranted. (Clinicaltrials.gov numbers, NCT00333138 [core study] and NCT00235430 [ClinicalTrials.gov] [extension].). Copyright 2006 Massachusetts Medical Society.

PMID: 16971719 [PubMed - in process]

You would think, after the Tysabri/Avonex/PML scare, they would quit mixing Avonex with anything for awhile. And remember the bad batch of Avonex a couple of years ago?

Sorry, I don't mean to diss Avonex, for those of you who are doing well on it. It almost killed me...well not really, but b/c of the side effects, I wanted to die.

I received a letter in the mail from NARCOMS today stating that there was a study starting for which I might be eligible. It is out of the University of Alabama at Birmingham and is entitled "Effects of Spinal cord injury on female sexual response: Effects of Multiple Sclerosis".

They are looking for study subjects that are female, 19-55 years of age, not pregnant, with normal periods. There is travel compensation and a study stipend if you participate.

For more information, call Paula Spath, the Clinical Coordinator toll free at 1-866-706-5545.

I get a number of notices of clinical trials but when NARCOMS sends information, I know it's a legitimate trial.