Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01422720
• Date of registration: 29/07/2011
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients
• Scientific title: Safety and Efficacy of Eslicarbazepine Acetate (ESL) as Adjunctive Therapy for Partial Seizures in Elderly Patients
• Date of first enrolment: April 2010
• Target sample size: 72
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01422720
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Austria, Bulgaria, Croatia, Czech Republic, Czechia, France, Germany, Poland, Portugal, Romania, Spain

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Written informed consent form;

2. Of age 65 years or older;

3. A documented diagnosis of epilepsy for at least 12 months,

4. At least 2 partial-onset seizures (including subtypes of simple partial, complex
partial and/or partial seizures evolving to secondarily generalised) in the 4 weeks
prior to screening;

5. Currently treated with 1 or 2 AEDs (any except oxcarbazepine) in a stable dosage
regimen for at least 4 weeks prior to screening. Vagus nerve stimulation (VNS) is to
be considered as an AED (i.e., only one concomitant AED is allowed in patients with
VNS);

6. Willing and able to comply with all trial requirements, in the judgment of the
investigator;

7. At least 2 partial-onset seizures (documented in the diary) per 4 weeks during the
8-week baseline period;

8. Satisfactorily complied with the study requirements during the baseline period

Exclusion Criteria:

1. Only simple partial seizures with no motor symptomatology (classified as A2-4)
according to the International Classification of Epileptic Seizures);

2. Primarily generalised seizures;

3. Known progressive neurological disorders (progressive brain disease, epilepsy
secondary to progressive central nervous system lesion) and progressive dementia;

4. Occurrence of seizures too close to count accurately;

5. History of status epileptic or cluster seizures 8i.e. 3 or more seizures within 30
minutes) within the 3 months prior to screening;

6. Seizures of non-epileptic origin;

7. Major psychiatric disorders;

8. History of suicide attempt;

9. Currently treated with oxcarbazepine;

10. Previous use of ESL or participation in a clinical study with ESL;

11. Known hypersensitivity to other carboxamide derivatives (e.g. oxcarbazepine,
carbamazepine) or to any of the excipients;

12. Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic,
haematological or oncology disorder, hypo - or hyper thyroidism of any type;

13. Second or third-degree atrioventricular blockade or any clinically significant
abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator;

14. Relevant clinical laboratory abnormalities as determined by the investigator (e.g.
plasma sodium <130 mmol/L, alanine or aspartate aminotransferases >2.0 times above the
upper limit of the range, or white blood cell count <3,000 cells/mm3;

15. Calculated creatinine values < 30 mL/min at screening;

16. Any other condition or circumstance that, in the opinion of the investigator, may
compromise the patient's ability to comply with the study protocol;

17. Received an investigational drug (or a medical device) within 3 months of screening or
is currently participating in another trial of an investigational drug (or medical
device) trial.



Age minimum: 65 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: Eslicarbazepine Acetate

Primary Outcome(s)

Number of Subjects With Reported Adverse Events (AE) [Time Frame: throughout the study]

Secondary Outcome(s)

Change From Baseline in Standardized Seizure Frequency [Time Frame: 8-week Baseline Period and 26-week Treatment Period]

Secondary ID(s)

0140BI17.MPB

2009-012587-14

BIA-2093-401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/07/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01422720