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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01830400
Other study ID # E2093-E044-404
Secondary ID
Status Completed
Phase N/A
First received April 8, 2013
Last updated August 18, 2015
Start date April 2012
Est. completion date June 2014

Study information

Verified date August 2015
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 254
Est. completion date June 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- The decision to prescribe ESL was made by the physician before and independently of his/her decision to include the patient in the study

- Patients treated with one drug licensed for monotherapy in partial onset seizures

- Based on the physician's clinical judgment, the patient seizure activity was not controlled sufficiently with a current monotherapy and it was in the patient's best interest to be prescribed adjunctive ESL

- Patient was prescribed ESL no longer than 2 weeks before the baseline

- Treatment with ESL was to be commenced in line with the drug's license and Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC)

- Aged 18 years or older

- Signed written informed consent

Exclusion Criteria:

- Patients that had started ESL outside the approved SPC at enrolment

- Simultaneous participation in an interventional clinical trial

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eisai Inc.

Countries where clinical trial is conducted

Czech Republic,  Denmark,  France,  Germany,  Ireland,  Norway,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline 6 months
Secondary 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. Baseline, 3 months and 6 months
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