EUCTR2007-005440-25-PTActive, not recruitingNot Applicable
A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-onset Seizures
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- SCHWARZ BIOSCIENCES, Inc.
- Enrollment
- 225
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
- •2. Subject has entered the Maintenance Phase of the double-blind trial, SP902 (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902.
- •3. Subject is expected to benefit from participation in an open-label extension trial with LCM, in the opinion of the investigator.
- •4. Subject is willing and able to comply with all trial requirements.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Subject is receiving any investigational drugs or using any experimental devices in addition to LCM.
- •2. Subject meets the withdrawal criteria (excluding exit criteria) for the previous trial (SP902) or is experiencing an ongoing serious adverse event (SAE).
Investigators
Similar Trials
Active, not recruiting
Phase 1
A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-onset SeizuresEUCTR2007-005440-25-FRSCHWARZ BIOSCIENCES, Inc.322
Active, not recruiting
Phase 1
A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-onset Seizures Ensayo de extension abierto multicentrico para evaluar el uso a largo plazo de la monoterapia con lacosamida y la seguridad de la momoterapia y el tratamiento complementario con lacosamida en pacientes con crisis parcialesPartial-onset seizures (with and without secondary generalization) Crisis parciales ( con o sin generalización secundaria)EUCTR2007-005440-25-ESSCHWARZ BIOSCIENCES, Inc.322
Active, not recruiting
Not Applicable
A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-onset SeizuresEUCTR2007-005440-25-ATSCHWARZ BIOSCIENCES, Inc.225
Active, not recruiting
Not Applicable
A continuation study to assess long term safety of Lacosamide (approved drug in Europe) monotherapy and safety of Lacosamide monotherapy and Adjuctive therapy in people with partial-onset seizuresPartial-onset seizures (with and without secondary generalization)MedDRA version: 14.1Level: PTClassification code 10010145Term: Complex partial seizuresSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.1Level: PTClassification code 10040703Term: Simple partial seizuresSystem Organ Class: 10029205 - Nervous system disordersEUCTR2007-005440-25-Outside-EU/EEACB BIOSCIENCES, Inc.294
Active, not recruiting
Not Applicable
Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset SeizuresPartial Epilepsies Partial Onset SeizuresMedDRA version: 17.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersEUCTR2014-004384-21-Outside-EU/EEACB BIOSCIENCES, Inc.100