Eslicarbazepine Acetate Monotherapy Long Term Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00910247
• Date of registration: 27/05/2009
• Prospective Registration: Yes
• Primary sponsor: Sunovion
• Public title: Eslicarbazepine Acetate Monotherapy Long Term Study
• Scientific title: Long Term Eslicarbazepine Acetate Extension Study
• Date of first enrolment: August 2009
• Target sample size: 274
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00910247
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Canada, Czech Republic, Czechia, Serbia, Ukraine, United States

Contacts

• Name: CNS Medical Director
• Affiliation: Sunovion Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: Eslicarbazepine acetate

Primary Outcome(s)

Number and Percent of Subjects With Treatment Emergent Adverse Events [Time Frame: One year]

Secondary Outcome(s)

Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in Those Subjects With a MADRS Score of =14 at Screening [Time Frame: baseline and Month 12]

Completion Rate (% of Subjects Completing Each Visit Post-one Year). [Time Frame: post 1 year]

Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium =135 mmol/L, =130 mmol/L, and =125 mmol/L [Time Frame: 1 year]

Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations [Time Frame: 1 year]

Responder Rate (Percentage of Subjects With a =50% Reduction of Seizure Frequency From Baseline). [Time Frame: One year]

Completion Rate (% of Subjects Completing the One Year Treatment) [Time Frame: One year]

Percentage of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS). [Time Frame: 1 year]

Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline. [Time Frame: Baseline, Month 12]

Treatment Retention Time (Time to Withdrawal Due to Lack of Efficacy or Adverse Events) [Time Frame: One year]

Time on Eslicarbazepine Acetate Monotherapy. [Time Frame: One year]

Change in Seizure Frequency From Baseline. [Time Frame: Month 12 from baseline]

Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31). [Time Frame: baseline and Month 12]

Percentage of Subjects With Increase of Body Weight =7% [Time Frame: 1 year]

Percentage of Subjects That Are Seizure-free During Study [Time Frame: 1 year]

Number and Percentage of Subjects With Orthostatic Effects. [Time Frame: 1 year]

Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS). [Time Frame: 1 year]

Secondary ID(s)

093-050

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/07/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00910247