Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00955357
First received: August 6, 2009
Last updated: June 10, 2014
Last verified: June 2014

August 6, 2009
June 10, 2014
August 2009
April 2013   (final data collection date for primary outcome measure)
The Proportion of Subjects Who Achieved "Seizure-free Status" During the First 12 Weeks of the Maintenance Phase [ Time Frame: From Week 7 (end of Week 6) to end of Week 18 ] [ Designated as safety issue: No ]

A subject will be considered seizure-free if the subject completes the first 12 weeks of the Maintenance Phase, reports zero seizures, and has no seizure data missing for any day during the period of time.

This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn.

The proportion of subjects who achieve "seizure-free status" during the first 12 weeks of the Maintenance Phase. [ Time Frame: First 12 weeks of the Maintenance Phase ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00955357 on ClinicalTrials.gov Archive Site
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Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
An Open-Label, Multicenter, Multinational Study of Lacosamide as First Add-On Anti-epileptic Drug (AED) Treatment in Subjects With Partial-Onset Seizures

To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.

The study consisted of 3 Periods: Period 1: a 1-week Screening Phase, Period 2: a 30-week Treatment Phase (consisting of a 6-week Titration Phase and a 24-week Maintenance Phase), and Period 3: a 3-week Taper/Safety Follow-Up Phase.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Partial Epilepsies
Drug: Lacosamide

Oral Lacosamide:

Subjects Titration Phase (6 Weeks):

Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks):

200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks):

50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

Other Names:
  • SPM927
  • Harkoseride
  • Vimpat
  • Experimental: First Add-on
    Lacosamide added to first adequate monotherapy (no history of Antiepileptic Drug [AED] polytherapy) and epilepsy diagnosis < or = 24 months at Screening.
    Intervention: Drug: Lacosamide
  • Experimental: Later Add-on
    Lacosamide added to 1 to 3 Antiepileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.
    Intervention: Drug: Lacosamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
461
August 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Group 1:

  • Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
  • Currently taking adequate monotherapy (defined as a single Antiepileptic Drug (AED) for at least 28 days prior to Screening) and has no history of AED polytherapy. Prior use of rescue medication (short-term intermittent use) is acceptable
  • Epilepsy diagnosis should be ≤24 months at the time of the Screening Visit
  • The minimum allowed seizure frequency at any time during the 12 weeks prior to the Screening Visit is ≥3 partial-onset seizures

Group 2:

  • Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
  • Currently taking 1 to 3 AEDs, and has tried at least 2 prior AED treatment regimens (concurrently or sequentially)
  • Epilepsy diagnosis should be ≥5 years at the time of the Screening Visit
  • The minimum allowed seizure frequency during the 12 weeks prior to the Screening Visit is ≥1 partial-onset seizure per 28 days

Exclusion Criteria:

  • Previous use of Lacosamide
  • History of seizure disorder characterized primarily by isolated auras
  • History of primary generalized seizures
  • History of status epilepticus within last 12-months
  • History of cluster seizures during the 12 week period prior to Visit 1
  • Nonepileptic events, including pseudoseizures that could be confused with seizure
  • Lifetime history of suicide attempt or suicidal ideation in the past 6 months
  • Hypersensitivity to any component of Lacosamide
  • History of drug or alcohol abuse
  • History of an acute or subacutely progressive Central Nervous System (CNS) disease
  • Undergone cranial surgery within the last year prior to study entry
  • Concomitant treatment of Felbamate or previous Felbamate therapy within the last 6 months
  • Prior or concomitant Vigabatrin use
Both
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Bulgaria,   Czech Republic,   Denmark,   Finland,   France,   Greece,   Italy,   Mexico,   Romania,   Russian Federation,   Spain,   Switzerland,   Turkey
 
NCT00955357
SP954, 2009-011181-28
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP