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
  Purpose

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.


Condition Intervention Phase
Partial Epilepsies
Drug: Lacosamide
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Multinational Study of Lacosamide as First Add-On Anti-epileptic Drug (AED) Treatment in Subjects With Partial-Onset Seizures

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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.



Enrollment: 461
Study Start Date: August 2009
Study Completion Date: August 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955357

  Show 109 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00955357     History of Changes
Other Study ID Numbers: SP954, 2009-011181-28
Study First Received: August 6, 2009
Results First Received: March 28, 2014
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration
Austria: Agency for Health and Food Safety
Bulgaria: Bulgarian Drug Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Mexico: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Spain: Ministry of Health
Switzerland: Swissmedic
Turkey: Ministry of Health

Keywords provided by UCB, Inc.:
Epilepsy Treatment
Anti-epileptic drugs
Seizures
Vimpat

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014