A clinical study to investigate the long-term use of Lacosamide as monotherapy in subjects who completed SP0994.
- Conditions
- Epilepsy with partial-onset seizures or generalized tonic-clonic seizuresMedDRA version: 20.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-001549-96-FI
- Lead Sponsor
- CB BioPharma SPR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
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, visit schedule, and medication intake according to the judgment of the investigator.
3. Subject has completed the Termination Visit of SP0994 and has been treated with Lacosamide monotherapy.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 134
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
1. Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide.
2. Subject experienced a seizure at the third target dose (ie, Lacosamide 600 mg/day) during SP0994.
3. Subject requires another antiepileptic drug for the treatment of seizures.
4. Subject meets a must” withdrawal criterion for the previous study, SP0994.
5. Subject is experiencing an ongoing serious adverse event from the previous study, SP0994.
6. Female subject who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 year postmenopausal or does not practice one highly effective method of contraception (according to ICH guidance defined as those that result in a failure rate of less than 1% per year when used consistently and correctly), unless sexually abstinent, for the duration of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term safety and tolerability of Lacosamide dosed at 200mg/day to 600mg/day when used as monotherapy in subjects, with partial-onset seizures or generalized tonic-clonic seizures (without clear focal origin), who completed SP0994.;Secondary Objective: Not applicable;<br> Primary end point(s): 1. Number of adverse events reported spontaneously by the subject and/or caregiver or observed by the investigator<br> 2. Percentage of withdrawals due to adverse events<br> 3. Number of serious adverse events reported spontaneously by the subject and/or caregiver or observed by the investigator<br> ;Timepoint(s) of evaluation of this end point: From Visit 1 (Week 0) to Final Visit (up to week 158)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable