Autonomic Technologies indleder europæisk forsøg med en helt ny neurostimulator til behandling af svær migræne
Virksomheden bygger videre på positive resultater med klyngehovedpine
Autonomic Technologies, Inc. (ATI), har udviklet et helt nyt implanterbart system i miniaturestørrelse til svær hovedpine og offentliggjorde i dag indledningen af et forsøg i Europa til evaluering af virkningen og sikkerheden af virksomhedens implantertbart forsøgsprodukt, et neurostimulationssystem, til behandling af hyppigt forekommende og stærkt invaliderende migræne. Det randomiserede multicenterforsøg Pathway M-1 vil optage 30 patienter, indledningsvist på førende hovedpinecentre i Danmark, Belgien, Spanien, Frankrig og Tyskland.
Migræne er den mest almindelige, invaliderende hovedpine og berører 11 % af befolkningen i Vesteuropa og i USA.1 Den kendetegnes ved dunkende, moderate til svære smerteanfald, der varer fra 4-72 timer, og som kan være forbundet med kvalme og følsomhed over for lys eller lyd. I henhold til Verdenssundhedsorganisationen (WHO) er svær migræne forbundet med betydelig invaliditet, højere end for visse hjertesygdomme, Parkinsons og Alzheimers sygdom.2
“Nuværende migrænebehandlinger inkluderer forebyggende medikamenter og akut anfaldsmedicin men disse lægemidler er ikke effektive for alle migrænepatienter,” udtaler professor, dr. med. Rigmor Højland Jensen, leder af Dansk Hovedpinecenter på Glostrup Hospital i Danmark og forsøgsansvarlig læge. “Nogle patienter kan ikke bruge disse lægemidler pga. hjertesygdom eller bivirkninger, og andre opnår ikke effektiv lindring. Der er et klart behov for en anden effektiv behandling for de mest svært berørte migrænikere, som ikke får lindring fra medicin.”
ATI-neurostimulationssystemet bliver aktuelt undersøgt i Pathway CH-1 forsøget til behandling af klyngehovedpine (Hortons Hovedpine), en usædvanlig svær hovedpinesygdom. Foreløbige resultater fra dette forsøg blev præsenteret på et møde i North American Neuromodulation Society i december 2011 af professor, dr. med. Jean Schoenen, der er koordinator på forskningsafdelingen for hovedpine på universitetet i Liege i Belgien. Disse foreløbige resultater påviste smertelindring ved 59 % af de behandlede hovedpiner. Et andet vigtigt fund var en halvering af hyppigheden af hovedpine hos 63 % af de behandlede patienter.
“På baggrund af de lovende resultater af vores behandling for klyngehovedpine er ATI og vores forskningsteam meget interesserede i starte tilsvarende undersøgelser på svært ramte migrænepatienter,” udtaler Ben Pless, administrerende direktør for Autonomic Technologies. “Vi håber, at vores arbejde en dag kan give lindring til tusindvis af patienter med svær hovedpine.”
Om ATI-neurostimulationssystemet
Forsøgsproduktet ATI-neurostimulationssystem er et helt nyt genopladeligt system med en implanterbar stimulator i miniaturestørrelse, som omtrent er på størrelse med en mandel, og som er beregnet til behandling af svær hovedpine, herunder klyngehovedpine og migræne. Neurostimulatoren indføres gennem en operation i overkæben og efterlader ikke udvendige ar. Spidsen af implantatets elektrode placeres ved sphenopalatine ganglion (SPG) nervebundtet dybt i ansigtet på hovedpines foretrukne side. I mange år har læger haft SPG som mål for at lindre svær hovedpine, primært ved at anvende lidocain og andre midler for at opnå en nerveblokering.
Ved at bruge en ekstern fjernbetjening, der er på størrelse med en stor mobiltelefon, giver patienten stimulation efter behov, så hovedpinen lindres. Når hovedpinen er behandlet, flyttes fjernbetjeningen blot væk fra kinden, hvilket slukker stimulationsbehandlingen.
ATI forventer at få det europæiske CE-mærke til brug af ATI-neurostimulationssystemet til behandling af klyngehovedpine i den nærmeste fremtid.
FDA (fødevare- og lægemiddelstyrelsen) i USA har godkendt ATI-neurostimulationssystem til forskningsbrug i USA til behandling af klyngehovedpine.
Om Pathway M-1 forsøget
Det nye multicenterforsøg Pathway M-1 vil starte i førende hovedpinecentre i Danmark, Belgien, Spanien, Frankrig og Tyskland. Der vil blive tilføjet andre europæiske centre senere hen på året. Forsøget vil optage mindst 30 patienter, som har mindst 4 migræneanfald om måneden og som har migrænesmerter mindst 8 dage om måneden. Få yderligere oplysninger om forsøget og de deltagende centre på www.ati-spg.com/m1/da1 .
Om Autonomic Technologies
Autonomic Technologies, Inc. (ATI) er en virksomhed i San Franciscoområde, som producerer medicinsk udstyr og får støtte fra blue chip-investorerne Kleiner Perkins Caufield and Byers, InterWest Partners, Versant Ventures, Novartis Ventures, Aberdare Ventures og Cleveland Clinic. Få yderligere oplysninger på www.ati-spg.com .
# # #
1 Goadsby, PJ, Lipton, RB, Ferrari, MD. (2002). "Migraine--current understanding and treatment." N Engl J Med 346(4): 257-270.
2 The Global Burden of Disease: 2004 Update. World Health Organization.
Contact:
Storbritannien:
Mike Sinclair
+44 (0)20 7318 2955
msinclair@halsin.com
eller
USA:
Mary
Bellack
+1 650 868 8450
mbellack@ati-spg.com
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