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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01235403
Other study ID # SP1007
Secondary ID 2010-019268-35
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2010
Est. completion date December 2011

Study information

Verified date March 2018
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy.

Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient has a diagnosis of partial-onset epilepsy with or without secondary generalization

- Currently taking 1 to 3 concomitant marketed antiepileptic drugs

- 18 years and older at study entry

Exclusion Criteria:

- Previous use of lacosamide

- Hypersensitivity to any component of lacosamide

- Patients with partial onset seizures not clearly identifiable

- History of generalized epilepsy

- History of status epilepticus within last 12 months

- Uncountable seizures due to clustering within last 12 weeks

- Non epileptic events, including pseudoseizures, conversion disorder that could be confused with seizures

- History of drug or alcohol abuse

- History of suicide attempt

- Progressive cerebral disease

- Concomitant treatment of felbamate

- Prior or concomitant vigabatrin use

- Under legal protection

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lacosamide
Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
UCB Pharma

Country where clinical trial is conducted

France, 

References & Publications (1)

Baulac M, Coulbaut S, Doty P, McShea C, De Backer M, Bartolomei F, Vlaicu M. Adjunctive lacosamide for focal epilepsy: an open-label trial evaluating the impact of flexible titration and dosing on safety and seizure outcomes. Epileptic Disord. 2017 Jun 1; — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed. During the study ( up to 24 - 28 weeks)
Primary Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed. During the study (up to 24 - 28 weeks)
Secondary Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100.
The overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase.
End of Treatment Period (24-week)
See also
  Status Clinical Trial Phase
Completed NCT00522275 - Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures Phase 3
Completed NCT00955357 - Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures Phase 4
Completed NCT00552305 - To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures Phase 2
Completed NCT00655551 - Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures Phase 3
Completed NCT00655486 - Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures Phase 3