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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Phase 4, randomised, parallel‐design, open‐label safety trial
2 treatment arms: TPM and ZNS
Participants Participants > 13 years with at least 2 seizures and 1 in the 3 months prior to screening and no AEDs in the previous 4 months
Estimated number enrolled = 140
Interventions Monotherapy with TPM or ZNS
Initial doses: TPM = 25 mg/d, ZNS = 100 mg/d. Maximum doses: TPM = 400 mg/d, ZNS = 600 mg/d
Outcomes Cognitive function (change from baseline at 24 weeks)
Notes Trial registered as NCT00154076 on ClincalTrials.gov and listed as completed but no results published. Trial sponsored by Eisai Korea, inquiries regarding this trial made to the sponsor but no data could be provided.
If more information on this trial can be found, this trial will be included in future updates of the review.