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Trial record 1 of 1 for:    NCT00520741
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Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures (ALEX-MT)

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ClinicalTrials.gov Identifier: NCT00520741
Recruitment Status : Completed
First Posted : August 27, 2007
Results First Posted : April 23, 2014
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Tracking Information
First Submitted Date  ICMJE August 24, 2007
First Posted Date  ICMJE August 27, 2007
Results First Submitted Date  ICMJE November 26, 2013
Results First Posted Date  ICMJE April 23, 2014
Last Update Posted Date July 19, 2018
Study Start Date  ICMJE August 2007
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2014)
Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s) [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ]
Pre-defined exit criteria:
  1. A 2-fold or greater increase in average monthly (28-day) partial seizure frequency (motor and non-motor) compared to average monthly partial seizure frequency (motor and non-motor) during the Baseline Phase
  2. A 2-fold or greater increase in consecutive 2-day partial seizure frequency (motor and non-motor) versus the highest consecutive 2-day partial seizure frequency (motor and non-motor) that occurred during the Baseline Phase. Note: if the highest consecutive 2-day partial seizure frequency during the Baseline Phase is 1, a 2-day partial seizure frequency of ≥3 is required to meet this exit criterion
  3. Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization
  4. A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation
  5. Status epilepticus, or new onset of serial/cluster seizures
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2007)
The primary outcome is the percentage of subjects who are identified as meeting pre-defined exit criteria by Day 112 relative to the start of withdrawal of background antiepileptic drug(s). [ Time Frame: 16 weeks (112 days) maintenance phase ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2014)
  • Time to First Occurrence of Any Exit Event During The Maintenance Period [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ]
    The time to first occurrence (days) of any exit event was estimated using Kaplan-Meier methods and was based on the time from the start of the Maintenance Phase to the earliest date a subject met an exit criterion. Subjects who discontinued during the Maintenance Phase due to non-exit criteria reasons or who completed the Maintenance Phase before 112 days and did not meet an exit criterion were censored as of the last Maintenance Phase dose date. Subjects completing 112 days in the Maintenance Phase were censored as of Day 112.
  • Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ]
    Subjects were classified as having an exit event if they experienced at least 1 of the following events during the Maintenance Phase as of Day 112:
    1. Met at least 1 exit criterion based on the calculations applied for the Primary Efficacy Analysis
    2. Withdrawal due to AE with onset during the Maintenance Phase
    3. Withdrew prematurely due to lack of efficacy during the Maintenance Phase
    The date the subject experienced the event was set to the earliest date the subject met an exit criterion or the date of the last Maintenance Phase dose for subjects not meeting an exit criterion but withdrawing due to an AE or lack of efficacy. The secondary analysis is only conducted on the Lacosamide 400 mg/day group.
  • Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12) [ Time Frame: Visit 9 - Visit 12 (approximately 10 weeks) ]
    Days on Monotherapy Treatment were defined as the number of days during the Monotherapy Phase when the subject took Lacosamide (LCM) only (ie, the total number of days exposed to LCM during the Monotherapy Phase minus any days where a concomitant or rescue Anti-epileptic Drug (AED) was taken by the subject). The days on Monotherapy Treatment did not need to be consecutive.
  • Clinical Global Impression of Change (CGIC) From Baseline To Last Visit [ Time Frame: Baseline; Last Visit (approximately 27 weeks) ]
    For the assessment of the Clinical Global Impression of Change (CGIC), the investigator should provide his/her assessment of the subject's clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status. He was asked the following:Please check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:
    1. Very much improved
    2. Much improved
    3. Minimally improved
    4. No change
    5. Minimally worse
    6. Much worse
    7. Very much worse
  • Patient's Global Impression of Change (PGIC) From Baseline To Last Visit [ Time Frame: Baseline; Last Visit (approximately 27 weeks) ]
    For the assessment of the Patient's Global Impression of Change, the subject should provide his/her assessment of his/her own clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status.The subject was asked to answer the following: Over the past 4 weeks, how have you felt compared to before you entered this clinical trial? (Please check the number that best describes your condition.)
    1. Very much improved
    2. Much improved
    3. Minimally improved
    4. No change
    5. Minimally worse
    6. Much worse
    7. Very much worse
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures
Official Title  ICMJE A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400 mg/Day Monotherapy in Subjects With Partial-onset Seizures
Brief Summary The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.
Detailed Description Sudden unexplained death in epilepsy have been reported in epilepsy patients. A causal relationship with the administration of antiepileptic drugs has not been established. The most important known risk factor for sudden unexplained death in epilepsy (SUDEP) is the occurrence and frequency of generalized tonic-clonic seizures (GTCS). Twenty-seven patients with only GTCS were enrolled in the conversion to monotherapy study. In this study, two patients with only GTCS had SUDEP. Due to the potential increased risk of SUDEP in patients with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from this study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • Drug: Lacosamide
    50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
    Other Name: Vimpat
  • Drug: Lacosamide
    50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
    Other Name: Vimpat
Study Arms  ICMJE
  • Experimental: Lacosamide 400 mg/day
    Lacosamide 400 mg/day
    Intervention: Drug: Lacosamide
  • Active Comparator: Lacosamide 300 mg/day
    Lacosamide 300 mg/day
    Intervention: Drug: Lacosamide
Publications * Wechsler RT, Li G, French J, O'Brien TJ, D'Cruz O, Williams P, Goodson R, Brock M; ALEX-MT Study Group. Conversion to lacosamide monotherapy in the treatment of focal epilepsy: results from a historical-controlled, multicenter, double-blind study. Epilepsia. 2014 Jul;55(7):1088-98. doi: 10.1111/epi.12681. Epub 2014 Jun 10.

*   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: March 20, 2014)
426
Original Estimated Enrollment  ICMJE
 (submitted: August 24, 2007)
357
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has a diagnosis of Epilepsy with Simple Partial Seizures (motor component) and or Complex Partial Seizures (with or without secondary generalization)
  • Must be experiencing 2 to 40 seizures per 28-day period
  • Stable dose of 1 or 2 marketed antiepileptic drugs
  • Second Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum recommended maintenance dose per USA product label at screening

Exclusion Criteria:

  • Subject has a history of primary generalized or unclassified seizures
  • Seizure disorder primarily characterized by isolated auras
  • History of status epilepticus
  • Seizures that are uncountable due to clustering
  • Has greater than 5 seizures/day
  • Subjects taking Benzodiazepines, Phenobarbital or Primidone
  • Subject has Vagus Nerve Stimulation (VNS)
  • Significant medical or psychiatric condition
  • History of alcohol or drug abuse
  • History of Ethosuximide use, Felbamate use after 1994 or Vigabatrin use after 1997
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,   Austria,   Canada,   Denmark,   France,   Germany,   Ireland,   Italy,   Poland,   Puerto Rico,   Spain,   United Kingdom,   United States
Removed Location Countries Switzerland
 
Administrative Information
NCT Number  ICMJE NCT00520741
Other Study ID Numbers  ICMJE SP0902
2007-005439-27 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB BIOSCIENCES, Inc. )
Study Sponsor  ICMJE UCB BIOSCIENCES, Inc.
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