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Trial record 1 of 1 for:    NCT00530855
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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00530855
First received: September 14, 2007
Last updated: May 8, 2013
Last verified: May 2013
History of Changes

September 14, 2007
May 8, 2013
February 2008
December 2014   (final data collection date for primary outcome measure)
  • Incidence of Subjects on Lacosamide (LCM) Monotherapy 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 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 ]
To obtain information about the percentage of subjects who remain on lacosamide monotherapy, and the duration of lacosamide monotherapy treatment. [ Time Frame: Subject participation can extend for 2 years following Visit 1, or until lacosamide is commerically available. ]
Complete list of historical versions of study NCT00530855 on ClinicalTrials.gov Archive Site
  • 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 ]

    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).
Obtain information about the long-term safety of lacosamide when used as monotherapy or adjunctive therapy by assessing adverse events, subject withdrawals, changes in hematology, blood chemistry and vital signs. [ Time Frame: Subject participation can extend for 2 years following Visit 1, or until lacosamide is commerically available. ]
Not Provided
Not Provided
 
Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
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

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).
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
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
Experimental: Lacosamide
Lacosamide tablets for dosing 100 -800 mg/day
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.
 
Active, not recruiting
322
December 2014
December 2014   (final data collection date for primary outcome measure)

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)
Both
16 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Denmark,   Germany,   Italy,   Poland,   Spain,   United Kingdom
 
NCT00530855
SP904
Not Provided
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
May 2013

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