Epilepsy
Conditions
Sponsors
UCB BIOSCIENCES GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject or by the parent(s) or legal representative. The Informed Consent form or a specific Assent form, where required, will be signed and dated by minors. 2. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator. 3. Subject has remained seizure free and completed the Maintenance Phase of the SP0993 monotherapy study; or subject has experienced 1 or more seizures on the first or second target dose (ie second target does without dose reduction) during the SP0993 Maintenance Phase; or subject has been transferred from SP0993 to SP0994 as a result of SP0993 Protocol Amendment 6.2 (Bulgaria , Canada, Germany, Japan, Latvia, Lithuania, Mexico, Philippines, Romania, Russia, Slovakia, South Korea, Sweden, Ukraine, United States) 4. Subject is expected to benefit from participation in SP0994 in the opinion of the investigator. Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 510 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM) or Cabamazepine Controlled Release (CBZ CR). 2. Subject experienced a seizure at the third target dose during the Evaluation Phase or Maintenance Phase of the SP0993 study. 3. Subject is taking benzodiazepines for a nonepilepsy indication. Benzodiazepines as rescue therapy for epilepsy may be used as needed, but not more frequently than once per week. 4. Subject meets a withdrawal criterion (ie, 'must withdraw') (other than the criterion of a seizure during the Maintenance Phase at the first or second target dose without dose reduction) for the previous study SP0993. 5. Subject is experiencing an ongoing SAE from the previous study SP0993. 6. For France, subject is covered by a judicial protection measure (ie, articles L.1121-6 and L.1121-8 of the French Public Health Code). 7. Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening. Or subject has a positive response (Yes) to either Question 4 or Question 5 of the C-SSRS at Screening in the “Since Last Visit” version.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are: • To obtain information about the long term safety of Lacosamide (LCM) in comparison with Carbamazepine Controlled Release (CBZ CR) when used as monotherapy in subjects with recently diagnosed partial onset or generalized tonic clonic seizures • To allow subjects who completed the monotherapy study SP0993 to continue to receive LCM or CBZ CR ;Secondary Objective: See section 4.1.2 and 4.2 of the protocol.;Primary end point(s): The primary safety variables are as follows: • AEs reported spontaneously by the subject and/or caregiver or observed by the investigator • Subject withdrawals due to AEs • SAEs The exploratory efficacy variables are: • Percentage of subjects seizure free • Time to discontinuation The exploratory health outcomes variables are: • Health care resource use: Additional health care provider visits unforeseen by the protocol and hospitalizations;Timepoint(s) of evaluation of this end point: End of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The other safety variables are as follows: • Changes in hematology, chemistry, and urinalysis parameters • Changes in 12-lead electrocardiograms (ECGs) • Changes in vital sign measurements (ie, blood pressure [BP] and pulse rate) • Changes in physical or neurological examination findings • Changes in body weight;Timepoint(s) of evaluation of this end point: End of trial | — |
Countries
Australia, Belgium, Bulgaria, Canada, Czech Republic, European Union, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, Ukraine, United Kingdom
Contacts
Public ContactClin Trial Registries and Results
UCB Biosciences GmbH
Outcome results
None listed