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MS Charcot Project: INSPIRE Trial fully recruited HERVs & EBV


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Charcot Project: INSPIRE Trial fully recruited

"In response to several requests, I can now confirm that recruitment for the INSPIRE Study is now complete. The study will be closed when the last subject completes 6 months, i.e. early January. Hence the results of the study will only be know in April/May. It takes this long to clean the data, lock the database and for our statistician to complete the analysis."
"I would like to thank all the staff for their dedication and hard work at getting to this point in time, my colleagues for referring patients for the study, Merck for funding the study, Queen Mary University of London for sponsoring the study and last but not least for the participants for volunteering for the study. Without volunteers we could never have got this far; thank you!"

A Phase II Baseline Versus Treatment Study to Determine the Efficacy of Raltegravir (Isentress) in Preventing Progression of Relapsing Remitting Multiple Sclerosis as Determined by Gadolinium-enhanced MRI

There is accumulating research evidence that Human Endogenous Retrovirus (HERV) and herpes viruses (in particular Epstein-Barr Virus) are involved in the pathogenesis of MS. People with active MS have higher levels of HERVs than people either without MS or who have other neurological conditions.

It has been shown that HERVs may produce neurotoxic proteins/antigens associated with MS activity and disease progression. This is the first clinical trial investigating the hypothesis that the antiretroviral drug raltegravir may suppress HERV activity and ameliorate progression of relapsing remitting MS. Raltegravir is an integrase inhibitor which blocks retroviral replication. A recent experimental study suggests that raltegravir may also be active against herpes viruses.

Eligible participants (see Inclusion/Exclusion Criteria) will be observed for 3 months having monthly brain Gadolinium enhanced MRIs and blood/urine/saliva sampling (baseline). Then they will be treated with raltegravir (one 400mg pill taken twice a day) for 3 months. During treatment period participants will continue to have monthly MRIs and blood/saliva/urine sampling. Participants will have monthly clinical and neurological examinations and they will complete questionnaires assessing response to treatment. Participants will have screening and study visits at The Royal London Hospital, Whitechapel. Monthly MRIs will be performed at the Institute of Neurology, UCL, Queen Square, London.

Why is this important to ME/CFS community? It opens the door to a new way of thinking concerning HERVs, EBV and other herpes viruses infections in other patient communties as well as possible new treatment protocols. We will know more on the completion of their trial as well as when Lipkins research paper is released in which he found HERV expression in Montoya samples (unknown if reference to both patient and controls).