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A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice

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: NCT00855738
Recruitment Status : Completed
First Posted : March 4, 2009
Results First Posted : July 23, 2010
Last Update Posted : December 10, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 3, 2009
First Posted Date  ICMJE March 4, 2009
Results First Submitted Date  ICMJE June 23, 2010
Results First Posted Date  ICMJE July 23, 2010
Last Update Posted Date December 10, 2010
Study Start Date  ICMJE May 2007
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2010)
Percent of Participants Classified as Responders [ Time Frame: Baseline, Month 3, Month 6 (last 3 months of treatment) ]
Responder = decrease in number of seizures by >=50 percent (%) during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the number of seizures that occurred during the 3 months before the baseline visit (baseline).
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2009)
Effectiveness (efficacy and tolerability) of the new antiepileptic drugs (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and topiramate, used as associated first therapy (bitherapy) in patients with focal epilepsy. [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT00855738 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2010)
  • Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment [ Time Frame: Baseline, Month 3, Month 6 (last 3 months of treatment) ]
    Percent of participants with reduction in number of seizures >=25% and >=75% during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the 3 month period before the baseline visit.
  • Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation [ Time Frame: Baseline, Month 3, Month 6 (last 3 months of treatment) ]
  • Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment [ Time Frame: Baseline, Month 3, Month 6 (last 3 months of treatment) ]
  • Percent of Days Without Crisis During the Study [ Time Frame: Baseline through Month 6 (or end of treatment) ]
    Crisis was defined as the total number of seizures during the study, the seizures at month 3 plus the seizures at month 6. The percent of days without crisis is number of days of study (date of last visit minus date of baseline visit) without crisis divided by number of days of study, multiplied by 100.
  • Time to First Seizure [ Time Frame: Baseline to Month 6 (or end of treatment) ]
    Number of days to first seizure after baseline.
  • Percent of Participants Who Continued on Study Medication to Month 6 [ Time Frame: Baseline to Month 6 ]
    Retention rate: percent of participants who continued on study medication throughout the 6 Month period after inclusion in the study.
  • Time to Discontinuation Due to Lack of Efficacy [ Time Frame: Baseline, Month 3, Month 6 ]
  • Time to Discontinuation Due to Safety, Tolerability, or Treatment Compliance [ Time Frame: Baseline, Month 3, Month 6 ]
  • Time to Discontinuation Due to Other Reasons [ Time Frame: Baseline, Month 3, Month 6 ]
  • Treatment Satisfaction Evaluated by Patient Global Impression of Change Visual Analog Scale (VAS) [ Time Frame: Baseline, Month 3, Month 6 ]
    Patient Global Impression of Change VAS: subject rated instrument to measure subject's change in overall status; range from 0 (much better) to 10 (much worse).
  • Percent of Participants Reaching Monotherapy [ Time Frame: Baseline through Month 6 (or end of study) ]
    Percent of participants who started on more than one treatment (bitherapy) and reached monotherapy by end of study.
  • Percent of Participants That Reduced, Maintained and Increased Their Doses of New Antiepileptic Drugs (AED) [ Time Frame: Baseline to Month 6 (or end of treatment) ]
  • Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy [ Time Frame: Baseline through Month 6 (or end of treatment) ]
  • Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline to Month 6 ]
    HADS: subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
  • Change From Baseline to Month 6 in Quality of Life 10 Domains (QOLIE-10) [ Time Frame: Baseline to Month 6 ]
    QOLIE-10: 10-item questionnaire evaluates health-related quality of life in individuals with epliepsy. Comprised of 7 components: seizure worry, overall quality of life, emotional well-being, energy, cognitive functioning, medication effects (physical and mental effects), and social function (work, driving, social function). Total score rated 0 to 100; higher score = higher quality of life.
  • Change From Baseline to Months 3 and 6 in Health Condition: Euro Quality of Life Scale (EQ-5D) Visual Analog Scale (VAS) [ Time Frame: Baseline, Month 3, Month 6 ]
    Assessment of the health condition of the subjects using the EQ-5D VAS: subject rated questionnaire to assess health-related quality of life in terms of a single index value. Using the VAS subjects rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
  • Change in Sleep Disturbances From Baseline to Month 6: Medical Outcomes Study Sleep Scale (MOS-SS) [ Time Frame: Baseline to Month 6 ]
    Subject rated instrument to assess key constructs of sleep; assesses sleep quality and quantity. Consists of a 6-item and 9-item overall sleep problems index measuring time to fall asleep and sleep duration in past 4 weeks; 5 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy. Transformed scores range = 0 to 100; higher score indicates greater intensity of attribute. Two additional subscales = sleep quantity (range 0-24 hours) and optimal sleep (number of participants with optimal sleep 7-8 hours per night).
  • Percent of Participants Indicating Optimal Sleep on the Optimal Sleep Subscale: Medical Outcomes Study Sleep Scale (MOS-SS) [ Time Frame: Baseline, Month 6 ]
    MOS-SS: subject rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Optimal sleep subscale is derived from sleep quantity average hours of sleep over the past 4 weeks; percent of participants with response YES (optimal) if sleep quantilty was 7-8 hours of sleep per night.
  • Change From Baseline to Month 6 in Visits to a Specialist or the Emergency Room Because of Epilepsy [ Time Frame: Baseline to Month 6 ]
    Numerical assessment of change in the number of visits to a specialist or the emergency room because of epilepsy needed during the study.
  • Change From Baseline to Month 6 in Total Number of Days Hospitalized Because of Epilepsy [ Time Frame: Baseline to Month 6 ]
    Numerical assessment of change in total number of days hospitalized because of epilepsy during the study.
  • Percent of Participants With Cessation of Occupation, Requirement of Caregiver, or Admission to Intensive Care Unit [ Time Frame: Month 6 ]
    Percent of participants with cessation of usual occupation, requirement of an informal caregiver, and who required admission to the intensive care unit (ICU).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2009)
  • To establish the effect of each new AED on quality of life measured with the QOLIE-10 scale. [ Time Frame: 6 months ]
  • To establish the influence of new AEDs in possible anxiety and depression disorders (frequent in patients with epilepsy) assessed by the HAD questionnaire and the health condition of the patient by the visual analogue scale VAS [ Time Frame: 6 months ]
  • To establish the possible relationship between AEDs and sleep disturbances (frequent in patients with epilepsy) assessed by the MOS Sleep questionnaire. [ Time Frame: 6 months ]
  • Use of health and non-health resources. [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
Official Title  ICMJE Liceo Study: A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
Brief Summary Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and topiramate, used as first-choice combination therapy (bitherapy) in patients with focal epilepsy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Focal Epilepsy
Intervention  ICMJE Drug: Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide
  • Gabapentin: up to 3.600 mg/d
  • Lamotrigine: up to 400 mg/d
  • Levetiracetam: up to 3.000 mg/d
  • Pregabalin: up to 600 mg/d
  • Oxcarbazepine: up to 2.400 mg/d
  • Tiagabine: up to 30 mg/d
  • Topiramate: up to 400 mg/d
  • Zonisamide: up to 500 mg/d
Other Name: Neurontin, Lamictal, Lyrica, Keppra, Topamax, Gabatril, Episen, Zonegran
Study Arms  ICMJE 1.0
Intervention: Drug: Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide
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: November 24, 2009)
111
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2009)
32
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 18 years or older.
  • Diagnosis of focal epilepsy.
  • Previous failure of one or more AEDs used in monotherapy.
  • Background treatment with an antiepileptic drug.
  • The investigator has considered that the patient must start treatment with some of the seven new AEDs in combination therapy: lamotrigine, levetiracetam, gabapentin, oxcarbazepine, pregabalin, tiagabine and/or topiramate.
  • History of seizures in the patient in the past 3 months.
  • The patient or legal guardian must be able to understand the characteristics of the study and fill in the seizure diaries.
  • Written informed consent.

Exclusion Criteria:

  • Inability to comply with the study requirements.
  • Diagnosis of generalized epilepsy or inability to establish if focal or generalized.
  • Presence of serious or uncontrolled systemic disease, serious psychiatric disease or progressive neurological disease.
  • History of alcoholism, drug addiction, or abuse of medicines in the past two years.
  • Psychogenic seizures in the two years prior to inclusion in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00855738
Other Study ID Numbers  ICMJE A0081144
LICEO STUDY
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2010

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