Small EPO trial

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Small EPO trial

Postby bromley » Thu Aug 30, 2007 12:32 am

EPO is being trialled for neuro-protection. This small study shows promise.

Exploring recombinant human erythropoietin in chronic progressive multiple sclerosis 30 August 2007

The neurodegenerative aspects of chronic progressive multiple sclerosis (MS) have received increasing attention in recent years, since anti-inflammatory and immunosuppressive treatment strategies have largely failed. However, successful neuroprotection and/or neuroregeneration in MS have not been demonstrated yet. Encouraged by the multifaceted neuroprotective effects of recombinant human erythropoietin (rhEPO) in experimental models, we performed an investigator-driven, exploratory open label study (phase I/IIa) in patients with chronic progressive MS. Main study objectives were (i) evaluating safety of long-term high-dose intravenous rhEPO treatment in MS, and (ii) collecting first evidence of potential efficacy on clinical outcome parameters.

Eight MS patients, five randomly assigned to high-dose (48 000 IU), three to low-dose (8000 IU) rhEPO treatment, and, as disease controls, two drug-naïve Parkinson patients (receiving 48 000 IU) were followed over up to 48 weeks: A 6-week lead-in phase, a 12-week treatment phase with weekly EPO, another 12-week treatment phase with bi-weekly EPO, and a 24-week post-treatment phase. Clinical and electrophysiological improvement of motor function, reflected by a reduction in expanded disability status scale (EDSS), and of cognitive performance was found upon high-dose EPO treatment in MS patients, persisting for three to six months after cessation of EPO application. In contrast, low-dose EPO MS patients and drug-naïve Parkinson patients did not improve in any of the parameters tested. There were no adverse events, no safety concerns and a surprisingly low need of blood-lettings.

This first pilot study demonstrates the necessity and feasibility of controlled trials using high-dose rhEPO in chronic progressive MS.

Hannelore Ehrenreich1, Benjamin Fischer1, Christine Norra1, Felix Schellenberger1, Nike Stender1, Michael Stiefel2, Anna-Leena Sirén1, Walter Paulus3, Klaus-Armin Nave1,4, Ralf Gold4 and Claudia Bartels1

1Max Planck Institute of Experimental Medicine, Departments of 2Radiology and 3Clinical Neurophysiology, Georg-August-University and 4Hertie Institute of Multiple Sclerosis Research, Göttingen, Germany

Source: Brain Copyright © 2007 Guarantors of Brain (30/08/07)
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Postby Toyoterry » Fri Aug 31, 2007 12:40 am

And unless I'm wrong, it could make you a great cyclist or distance runner as well.
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Postby Tony » Thu Sep 06, 2007 2:02 am

Hi all!

I participated in this trial. I was the first one they started with, so I was treated for 2 years and I know that I received the 48.000 units dosage. No side effects.

During the first months, I did infact better, but during the six months break, I fell back to more or less the status of the beginning, maybe a bit better. During the second year, it did not help any more.

So I can say that maybe for one year, it held more or less my status, the longer walking distances of the first months may be due to a placebo effect (Ms Ehrenreich is a very convincing person, but also very difficult as I discovered at a later stage of the trial) or a doping effect, however, my blood parameters did not change a lot, in particular the hematocrit did not increase much which is curious!

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