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Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures

This study has been completed.
Information provided by (Responsible Party):
UCB Pharma Identifier:
First received: September 14, 2007
Last updated: May 18, 2015
Last verified: May 2015
This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).

Condition Intervention Phase
Drug: Lacosamide
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ] [ Designated as safety issue: No ]
    Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.

  • Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ] [ Designated as safety issue: No ]
    Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.

Secondary Outcome Measures:
  • Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ] [ Designated as safety issue: No ]

    A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.

    An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).

  • Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ] [ Designated as safety issue: No ]

Enrollment: 322
Study Start Date: February 2008
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide
Lacosamide tablets for dosing 100 -800 mg/day
Drug: Lacosamide
50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years
Other Name: Vimpat


Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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; subject is allowed up to 2 concomitant Antiepileptic Drugs (AEDs)

Exclusion Criteria:

  • Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00530855

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Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Responsible Party: UCB Pharma Identifier: NCT00530855     History of Changes
Other Study ID Numbers: SP0904  2007-005440-25 
Study First Received: September 14, 2007
Results First Received: May 18, 2015
Last Updated: May 18, 2015
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines
Denmark: Danish Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Italy: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB Pharma:
Partial-onset Seizures

Additional relevant MeSH terms:
Anticonvulsants processed this record on May 26, 2016