PMID- 16990078
OWN - NLM
STAT- MEDLINE
DCOM- 20061012
LR  - 20181201
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 28
IP  - 7
DP  - 2006 Jul
TI  - Efficacy and tolerability of topiramate 200 mg/d in the prevention of migraine 
      with/without aura in adults: a randomized, placebo-controlled, double-blind, 
      12-week pilot study.
PG  - 1002-11
AB  - BACKGROUND: Several large, randomized, double-blind, placebo-controlled trials 
      have found topiramate (TPM) to be effective and generally well tolerated as a 
      preventive therapy for migraine. OBJECTIVE: This paper evaluates efficacy and 
      safety data from a pilot study of TPM 200 mg/d as preventive therapy in adult 
      subjects with a history of migraine with or without aura. METHODS: The pilot 
      study had a randomized, double-blind, placebo-controlled design. Subjects were 
      randomized in a 2:1 ratio to receive TPM 200 mg/d or placebo. The double-blind 
      treatment phase consisted of an 8-week titration period (25 mg/d for the first 
      week, followed by weekly increases of 25 mg) and a 12-week maintenance period. 
      The primary efficacy measure was the change in mean monthly migraine frequency. 
      Additional measures were the median percent reduction in monthly migraine 
      frequency and the proportion of responders (those with > or =50%, > or =75%, or 
      100% reduction in monthly migraine frequency). RESULTS: The intent-to-treat (ITT) 
      population included 211 subjects (138 TPM, 73 placebo; mean [SD] mean weight, 
      76.7 [18.7] kg). Of 45 subjects who discontinued the study in the TPM group, 21 
      discontinued during the titration period, compared with 3 of 13 subjects who 
      discontinued in the placebo group. When the efficacy data were assessed using the 
      per-protocol, analysis-of-covariance model, TPM 200 mg/d was not associated with 
      a significant reduction in mean monthly migraine frequency compared with placebo. 
      A post hoc analysis using a Poisson regression model in the ITT population 
      suggested that TPM significantly reduced mean monthly migraine frequency compared 
      with placebo (P=0.04). A significantly larger proportion of TPM-treated subjects 
      had a > or =75% reduction in monthly migraine frequency compared with placebo 
      (P=0.03). At least 1 adverse event was reported by 90.0% and 69.9% of the TPM and 
      placebo groups, respectively. Treatment-emergent adverse events (AEs) occurring 
      in > or =10% of subjects in the TPM group were paresthesia (45%), dizziness 
      (16%), fatigue (16%), nausea (14%), and weight loss (14%). Most 
      treatment-emergent AEs were rated mild or moderate in severity. Of 3 serious AEs 
      (depression, abdominal pain, leg pain) occurring during the trial, none were 
      considered related to either TPM or placebo. CONCLUSION: In this pilot study, 
      mean monthly migraine frequency did not differ significantly between TPM and 
      placebo.
FAU - Silberstein, Stephen D
AU  - Silberstein SD
AD  - Jefferson Headache Center, Thomas Jefferson University Hospital, Philadelphia, PA 
      19107, USA. stephen.silberstein@jefferson.edu
FAU - Hulihan, Joseph
AU  - Hulihan J
FAU - Karim, M Rezaul
AU  - Karim MR
FAU - Wu, Shu-Chen
AU  - Wu SC
FAU - Jordan, Donna
AU  - Jordan D
FAU - Karvois, Debra
AU  - Karvois D
FAU - Kamin, Marc
AU  - Kamin M
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Anticonvulsants)
RN  - 0H73WJJ391 (Topiramate)
RN  - 30237-26-4 (Fructose)
SB  - IM
EIN - Clin Ther. 2006 Sep;28(9):1482
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anticonvulsants/*adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Fructose/adverse effects/*analogs & derivatives/therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Migraine with Aura/epidemiology/*prevention & control
MH  - Migraine without Aura/epidemiology/*prevention & control
MH  - Pilot Projects
MH  - Poisson Distribution
MH  - Topiramate
EDAT- 2006/09/23 09:00
MHDA- 2006/10/13 09:00
CRDT- 2006/09/23 09:00
PHST- 2006/06/13 00:00 [accepted]
PHST- 2006/09/23 09:00 [pubmed]
PHST- 2006/10/13 09:00 [medline]
PHST- 2006/09/23 09:00 [entrez]
AID - S0149-2918(06)00165-2 [pii]
AID - 10.1016/j.clinthera.2006.07.003 [doi]
PST - ppublish
SO  - Clin Ther. 2006 Jul;28(7):1002-11. doi: 10.1016/j.clinthera.2006.07.003.