An observational study in Partial Onset Seizures, sponsored by Eisai Inc.. Completed at 107 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-19.
Sponsored by Eisai Inc. · Observational
This was a Non-interventional Prospective Study. Centres enrolled adult patients with partial-onset seizures with or without secondary generalisation for whom the clinician had decided to initiate Eslicarbazepine Acetate (ESL) as an adjunctive therapy prior to the decision to take part in this study. Patients enrolled into the study were not sufficiently controlled with one drug licensed for the use as monotherapy in partial-onset seizures. Patients were seen at baseline and then during normal clinical visits at intervals. Patients in this study were assessed for efficacy and tolerability at baseline and then at least 3 and 6 months after the baseline.
881 studies on the registry are indexed under Seizures; 143 are open to participants now.
This study's enrollment of 254 is above the median of 150 across 235 observational studies indexed under Seizures.
Browse Seizures studies →Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Normal clinical practice setting/ centre.
Exclusion Criteria:
Drug: Eslicarbazepine Acetate tablets
The Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC) recommended a starting dose of 400 mg once-daily (QD) which was increased to 800 mg QD after one or two weeks. Based on individual response, the dose was increased to 1200 mg QD. Treatment decisions were made by clinicians in agreement with the participant, and were independent of participation in the study.
Also known as: ESL
Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline
Time frame: 6 months
Change in Overall Seizure Frequency after 3 and 6 months from Baseline
Change in overall seizure frequency calculated as absolute and percent changes after 3 and 6 months from baseline compared to the seizure frequency 3 months before introduction of ESL.
Time frame: Baseline, 3 months and 6 months
Showing the first 100 of 107 sites across 8 countries.
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Eisai Inc.