ong-Term Eslicarbazepine Acetate Extension Study

Phase 1

• Conditions: Partial epilepsy; MedDRA version: 19.0Level: LLTClassification code 10065336Term: Partial epilepsySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-019000-22-CZ
• Lead Sponsor: Sunovion Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-03
• Last Update Posted: 17 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

1.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.
2.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.
3.Subject must continue to meet the inclusion and not meet the exclusion criteria defined in Protocols 093-045 or 093-046 and not present with any safety concerns (as determined by the Investigator).
4.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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 338
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Subject with serum sodium level =125 mmol/L.
2.Subject with any kind of hypersensitivity (especially manifested as rash) suspected to be induced by eslicarbazepine, carbamazepine, oxcarbazepine, or chemically-related substances.
3.Subject who needs to initiate prohibited concomitant medications.
4.Subject who needs to reduce eslicarbazepine acetate dose to <800 mg QD or increase dose to >2400 mg QD.
5.Subject who needs to use >2 additional AEDs. If applicable, provide sufficient study drug to taper subject off of study drug (taper schedule is at the Investigator’s discretion). Schedule a follow-up (unscheduled) visit, if applicable, to assess AEs and to collect all remaining study drug in the original container (including any empty containers).
Please also refer to Section 12, Discontinuation and Replacement of Subjects.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified