PMID- 11164700
OWN - NLM
STAT- MEDLINE
DCOM- 20010419
LR  - 20190915
IS  - 0920-1211 (Print)
IS  - 0920-1211 (Linking)
VI  - 43
IP  - 2
DP  - 2001 Feb
TI  - Rufinamide: a double-blind, placebo-controlled proof of principle trial in 
      patients with epilepsy.
PG  - 115-24
AB  - 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.
FAU - Palhagen, S
AU  - Palhagen S
AD  - Department of Neurology, University Hospital, SE-58185, Linkoping, Sweden.
FAU - Canger, R
AU  - Canger R
FAU - Henriksen, O
AU  - Henriksen O
FAU - van Parys, J A
AU  - van Parys JA
FAU - Riviere, M E
AU  - Riviere ME
FAU - Karolchyk, M A
AU  - Karolchyk MA
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Netherlands
TA  - Epilepsy Res
JT  - Epilepsy research
JID - 8703089
RN  - 0 (Anticonvulsants)
RN  - 0 (Triazoles)
RN  - WFW942PR79 (rufinamide)
SB  - IM
MH  - Adult
MH  - Anticonvulsants/adverse effects/blood/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Epilepsy/*drug therapy
MH  - Female
MH  - Half-Life
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Nervous System Diseases/chemically induced
MH  - Seizures/epidemiology
MH  - Triazoles/adverse effects/blood/*therapeutic use
EDAT- 2001/02/13 11:00
MHDA- 2001/04/21 10:01
CRDT- 2001/02/13 11:00
PHST- 2001/02/13 11:00 [pubmed]
PHST- 2001/04/21 10:01 [medline]
PHST- 2001/02/13 11:00 [entrez]
AID - S0920-1211(00)00185-6 [pii]
AID - 10.1016/s0920-1211(00)00185-6 [doi]
PST - ppublish
SO  - Epilepsy Res. 2001 Feb;43(2):115-24. doi: 10.1016/s0920-1211(00)00185-6.