Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00530855
Recruitment Status : Completed
First Posted : September 18, 2007
Results First Posted : June 3, 2015
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE September 14, 2007
First Posted Date  ICMJE September 18, 2007
Results First Submitted Date  ICMJE May 18, 2015
Results First Posted Date  ICMJE June 3, 2015
Last Update Posted Date July 18, 2018
Study Start Date  ICMJE February 2008
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2015)
  • 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) ]
    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) ]
    Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2007)
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. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2015)
  • 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) ]
    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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2007)
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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Lacosamide
Lacosamide tablets for dosing 100 -800 mg/day
Intervention: Drug: Lacosamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2013)
322
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2007)
225
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Denmark,   Germany,   Italy,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00530855
Other Study ID Numbers  ICMJE SP0904
2007-005440-25 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date July 2017

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