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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00855738
First received: March 3, 2009
Last updated: November 23, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Focal Epilepsy
 Drug: Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Liceo Study: A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percent of Participants Classified as Responders [ Time Frame: Baseline, Month 3, Month 6 (last 3 months of treatment) ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Percent of Days Without Crisis During the Study [ Time Frame: Baseline through Month 6 (or end of treatment) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Time to Discontinuation Due to Safety, Tolerability, or Treatment Compliance [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]
  • Time to Discontinuation Due to Other Reasons [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]
  • Treatment Satisfaction Evaluated by Patient Global Impression of Change Visual Analog Scale (VAS) [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percent of participants with cessation of usual occupation, requirement of an informal caregiver, and who required admission to the intensive care unit (ICU).
Enrollment: 111
Study Start Date: May 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1.0 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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855738

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00855738     History of Changes
Other Study ID Numbers: A0081144, LICEO STUDY
Study First Received: March 3, 2009
Results First Received: June 23, 2010
Last Updated: November 23, 2010
Health Authority: Spain: Consejeria de Sanidad y Consumo de la Comunidad de Madrid and AEMyPS

Keywords provided by Pfizer:
epilepsy antiepileptic biotherapy

Additional relevant MeSH terms:
Anticonvulsants
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015