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 seizures

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005440-25-GB

Enrollment

294

Registered

2008-07-15

Start date

2009-02-16

Completion date

Unknown

Last updated

2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial-onset seizures (with and without secondary generalization) MedDRA version: 16.1 Level: PT Classification code 10010145 Term: Complex partial seizures System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1 Level: PT Classification code 10040703 Term: Simple partial seizures System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Vimpat Product Name: Lacosamide Product Code: SPM 927 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Lacosamide CAS Number: 175481-36-4 Current Sponsor code: SPM 927 Concent

Eligibility

Sex/Gender

All

Inclusion criteria

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: 44 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 221 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 29

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
Main Objective: Obtain information about the percentage of subjects who remain on LCM monotherapy, and the duration of LCM monotherapy treatment. Obtain information about the long-term safety of LCM when used as monotherapy or adjunctive therapy in subjects with partial-onset seizures. ;Secondary Objective: There are no secondary objectives;Primary end point(s): Long-term use of LCM monotherapy will be assessed using the following variables: • Percentage of subjects on LCM monotherapy • Duration of LCM monotherapy treatment;Timepoint(s) of evaluation of this end point: Up to 2 years	—

Measure

Time frame

Main Objective: Obtain information about the percentage of subjects who remain on LCM monotherapy, and the duration of LCM monotherapy treatment. Obtain information about the long-term safety of LCM when used as monotherapy or adjunctive therapy in subjects with partial-onset seizures. ;Secondary Objective: There are no secondary objectives;Primary end point(s): Long-term use of LCM monotherapy will be assessed using the following variables: • Percentage of subjects on LCM monotherapy • Duration of LCM monotherapy treatment;Timepoint(s) of evaluation of this end point: Up to 2 years

—

Secondary

Measure	Time frame
Secondary end point(s): There are no secondary endpoints;Timepoint(s) of evaluation of this end point: There are no secondary endpoints	—

Countries

Australia, Austria, Canada, Denmark, France, Germany, Ireland, Italy, Portugal, Spain, United Kingdom, United States

Contacts

Public ContactClinTrial Reg & Results Disclosure

UCB BIOSCIENCES GmbH

clinicaltrials@ucb.com+49 2173 48 1515

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026