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Fluge & Mella – phase II – Under way
- An open-label study
- Aim: to test the impact of adding maintenance treatments of Rituximab (at 3, 6, 10 & 15 months) to their existing protocol
- Follow-up period: 36months
- n=30 (sample size)
- Expected completion of data collection December 2013 (so publication would be unlikely before mid 2014)
Fluge & Mella – phase II – Still recruiting (but might nevertheless have commenced the trial)
- An open-label study
- This study differs from their other current Phase II trial in two key ways:
(i) The cohort for this trial is to consist of (only) severely ill ME/CFS patients
(ii) Up to half of the patients in this trial are to receive plasma exchange as well as Rituximab (see notes below on plasma exchange therapy**)
- Follow-up period: 36mths
Fluge & Mella – phase III – Not yet underway
- This is to be a large sample, double-blinded placebo-controlled study;
- It is to be a multi-center study, conducted at several Norwegian university clinics;
- They have substantial funding from the Norwegian government, but are currently trying to raise additional funding;
- This study will utilize the findings from their current (n=30) study. It’s final design will be influenced by those findings, and so it can’t commence until they have collected at least preliminary data from that current study. It’s been reported in Norway that the study may commence in summer (ie northern hemisphere summer);
- Publication is presumably more than 3 years away.
Spanish researchers – ?? – Under way ??
Dr Derek Enlander has stated a desire to conduct a replication study in conjunction with Dr David Bell, but they would have to raise the funding first (ie they’d be trying to replicate the findings of Fluge and Mella’s 2011 publication).
Dr Andy Kogelnik is currently treating some ME/CFS patients with Rituximab (off-label), and is said to be expecting to have a formal clinical trial running by the end of 2012. He’s proposing to treat patients with the combination of Rituximab and an antiviral. He’s been trying to get this trial going since 2010.
[In his proposed trial, he'd like to use a new antiviral, valomaciclovir, but has been struggling to get permission to administer it for periods in excess of one month. If he can't use this, he'd use Valcyte instead.]
Dr Klimas might also be trying to arrange a study.