An international open-label extension trial to determine safety and efficacy of long-term oral SPM 927 in patients with partial seizures

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000152-16-LT

Enrollment

577

Registered

2004-10-11

Start date

2004-10-13

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Partial seizures MedDRA version: 6.0 Level: LLT Classification code 10034089

Interventions

Trade Name: Vimpat Product Name: Lacosamide Product Code: SPM 927 Pharmaceutical Form: Film-coated tablet CAS Number: 175481-36-4 Concentration unit: mg milligram(s) Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects must fulfill the following 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 completed the Maintenance and Transition Phases of the clinical trial, SP755, for the treatment of partial seizures. 3. Subject is expected to benefit from participation, 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

Exclusion criteria: Subjects are not permitted to enroll in the trial if any of the following criteria are met: 1. Subject is receiving any investigational drugs or using any experimental devices in addition to SPM 927. 2. Subject meets the withdrawal criteria for the previous trial (SP755) or is experiencing an ongoing serious adverse event.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objectives of this trial are: • To obtain information about the safety of SPM 927 during long-term exposure • To obtain data on seizure reduction and the maintenance of efficacy by SPM 927 during long-term exposure • To allow subjects who have completed an SPM 927 epilepsy trial to receive SPM 927 ;Secondary Objective: ./.;Primary end point(s): Safety and tolerability will be assessed using the following variables: • Adverse events reported spontaneously by the subject and/or caregiver or observed by the investigator • Subject withdrawal due to adverse events • Changes in hematology, blood chemistry, and urinalysis parameters • Changes in 12-lead ECGs • Changes in vital sign measurements (i.e., blood pressure, heart rate) • Changes in physical or neurological examination findings • Changes in body weight	—

Measure

Time frame

Main Objective: The objectives of this trial are: • To obtain information about the safety of SPM 927 during long-term exposure • To obtain data on seizure reduction and the maintenance of efficacy by SPM 927 during long-term exposure • To allow subjects who have completed an SPM 927 epilepsy trial to receive SPM 927 ;Secondary Objective: ./.;Primary end point(s): Safety and tolerability will be assessed using the following variables: • Adverse events reported spontaneously by the subject and/or caregiver or observed by the investigator • Subject withdrawal due to adverse events • Changes in hematology, blood chemistry, and urinalysis parameters • Changes in 12-lead ECGs • Changes in vital sign measurements (i.e., blood pressure, heart rate) • Changes in physical or neurological examination findings • Changes in body weight

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Countries

Czech Republic, Finland, Hungary, Lithuania, Spain, Sweden, United Kingdom

Outcome results

None listed

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