Phase 3
Completed N=274
Eslicarbazepine Acetate Monotherapy Long Term Study
Source: ClinicalTrials.gov NCT00910247 ↗Enrolled (actual)
274
Serious AEs
11.7%
Results posted
Jul 2018
Primary outcomePrimary: Number and Percent of Subjects With Treatment Emergent Adverse Events — 220 Participants
Summary
This is a long term, open-label, safety extension study in subjects with partial onset seizures.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percent of Subjects With Treatment Emergent Adverse Events |
220 | — |
| SECONDARY Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations |
186 | — |
| SECONDARY Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L |
48; 22; 4 | — |
| SECONDARY Percentage of Subjects With Increase of Body Weight ≥7% |
27 | — |
| SECONDARY Number and Percentage of Subjects With Orthostatic Effects. |
67 | — |
| SECONDARY Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline. |
0; 9; 1; 0; 42 | — |
| SECONDARY Percentage of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS). |
4.0; 0.7; 3.6 | — |
| SECONDARY Time on Eslicarbazepine Acetate Monotherapy. |
NA | — |
| SECONDARY Change in Seizure Frequency From Baseline. |
-66.4 | — |
| SECONDARY Responder Rate (Percentage of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline). |
62.4 | — |
| SECONDARY Percentage of Subjects That Are Seizure-free During Study |
7.3 | — |
| SECONDARY Completion Rate (% of Subjects Completing the One Year Treatment) |
74.8 | — |
| SECONDARY Treatment Retention Time (Time to Withdrawal Due to Lack of Efficacy or Adverse Events) |
NA | — |
| SECONDARY Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31). |
6.6 | — |
| SECONDARY Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS). |
-1.5 | — |
| SECONDARY Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in Those Subjects With a MADRS Score of ≥14 at Screening |
-1.5 | — |
| SECONDARY Completion Rate (% of Subjects Completing Each Visit Post-one Year). |
66.7 | — |
Eligibility Criteria
Subject Inclusion/Exclusion Criteria:
- Subject who completed, exited, or discontinued for reasons other than safety from the 18-week treatment phase of Protocols 093-045 or 093-046 and are willing to continue participation in this study are eligible. Subject must have completed at least the first 3 weeks of the 18-week double-blind treatment period of Protocols 093-045 or 093-046 to be eligible.
- Subject must give written informed consent prior to participation in the study. For subjects <18 years of age, the informed consent must be signed by the subject's parent or legal guardian, and, when appropriate and/or required by state or local law, minor subjects must give written informed assent prior to participation in the study. All subjects must sign privacy authorization form, if applicable. All females of child bearing potential (≤65 years of age) must also sign the "Women of Childbearing Potential" Addendum.
- Subjects must, in the opinion of the Investigator (with consultation with Medical Monitor as appropriate), continue to potentially benefit from continued study participation and have no new medical conditions that would preclude study participation.
- If female subject, must continue the accepted method of birth control defined in Protocols 093-045 or 093-046 for the duration of this study as well
- Criterion for Continuation into the Post 1 year Part of Study:
For subjects to continue into the post 1 year part of the study, subjects must, in the opinion of the Investigator (with consultation with Medical Monitor, as appropriate), continue to potentially benefit from continued study participation and have no new medical conditions that would preclude study participation.
Data sourced from ClinicalTrials.gov (NCT00910247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.