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Sökning: WFRF:(Pålhagen Sven E) > (2001-2004) > Rufinamide :

LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00003356naa a2200397 4500
001oai:DiVA.org:liu-47472
003SwePub
008091011s2001 | |||||||||||000 ||eng|
024a https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-474722 URI
024a https://doi.org/10.1016/S0920-1211(00)00185-62 DOI
040 a (SwePub)liu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
100a Pålhagen, Svenu Linköpings universitet,Hälsouniversitetet,Geriatrik4 aut0 (Swepub:liu)svepa72
2451 0a Rufinamide :b A double-blind, placebo-controlled proof of principle trial in patients with epilepsy
264 1c 2001
338 a print2 rdacarrier
520 a Objective: This was the first proof of principle clinical trial assessing the efficacy and safety of rufinamide as adjunctive therapy in epileptic patients. The pharmacokinetic (PK) profile of rufinamide was also determined. Methods: Fifty patients with diagnoses of partial or primary generalized tonic-clonic seizures were enrolled in this 28-day double-blind, placebo-controlled, weekly rising dose (400-1600 mg/day) trial. PK profiles were obtained after administration of single-dose rufinamide prior to and after the Double-blind phase. Results: In the evaluable patient population, seizure frequency decreased by 41% in the rufinamide group and increased by 52% in the placebo group (P = 0.040). Thirty-nine percent (39%) of rufinamide-treated and 16% of placebo-treated patients experienced reduction in seizure frequency of at least 50% relative to baseline (P = 0.096). Safety: Treatment-emergent adverse events (AEs) consisted mainly of neurologic signs and symptoms commonly associated with antiepileptic drugs (AEDs). Pharmacokinetics: At steady state, rufinamide reached a peak plasma concentration with a mean time (Tmax) of 3.4 h and a mean half-life (t1/2) of 7.3 h. No autoinduction of rufinamide metabolism occurred. Rufinamide did not influence the plasma concentration of carbamazepine, phenytoin or valproate when added to these single AED regimens. Conclusion: Rufinamide has been shown, in this proof of principle trial, to be safe and effective in reducing seizure frequency in epileptic patients with no relevant influence on the metabolism of other AEDs. © 2001 Elsevier Science B.V.
653 a AED
653 a Antiepileptic agents
653 a Pharmacokinetics
653 a Rufinamide
653 a Seizures
653 a MEDICINE
653 a MEDICIN
700a Canger, R.u Centro Per l'Epilessia, Ospedale S. Paolo, Milan, Italy4 aut
700a Henriksen, O.u National Centre for Epilepsy, Postbox 900, N-1337 Sandvika, Norway4 aut
700a Van, Parys J.A.u Van Parys, J.A., Instituut Voor Epilepsie Bestrijding, Heemstede, Netherlands4 aut
700a Riviere, M.-E.u Rivière, M.-E., CRD, S-27.7.061, Novartis Pharma AG, CH-4002 Basel, Switzerland4 aut
700a Karolchyk, M.A.u CRD, S-27.7.061, Novartis Pharma AG, CH-4002 Basel, Switzerland4 aut
710a Linköpings universitetb Hälsouniversitetet4 org
773t Epilepsy Researchg 43:2, s. 115-124q 43:2<115-124x 0920-1211x 1872-6844
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-47472
8564 8u https://doi.org/10.1016/S0920-1211(00)00185-6

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