Clinical trial NCT00855738: A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
Official title: Liceo Study: A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Focal Epilepsy
Keywords: epilepsy antiepileptic biotherapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-04
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percent of Participants Classified as Responders
timeFrame: Baseline, Month 3, Month 6 (last 3 months of treatment)
Secondary outcomes:
measure: Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment
timeFrame: Baseline, Month 3, Month 6 (last 3 months of treatment)
measure: Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation
timeFrame: Baseline, Month 3, Month 6 (last 3 months of treatment)
measure: Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment
timeFrame: Baseline, Month 3, Month 6 (last 3 months of treatment)
measure: Percent of Days Without Crisis During the Study
timeFrame: Baseline through Month 6 (or end of treatment)
measure: Time to First Seizure
timeFrame: Baseline to Month 6 (or end of treatment)
measure: Percent of Participants Who Continued on Study Medication to Month 6
timeFrame: Baseline to Month 6
measure: Time to Discontinuation Due to Lack of Efficacy
timeFrame: Baseline, Month 3, Month 6
measure: Time to Discontinuation Due to Safety, Tolerability, or Treatment Compliance
timeFrame: Baseline, Month 3, Month 6
measure: Time to Discontinuation Due to Other Reasons
timeFrame: Baseline, Month 3, Month 6
measure: Treatment Satisfaction Evaluated by Patient Global Impression of Change Visual Analog Scale (VAS)
timeFrame: Baseline, Month 3, Month 6
measure: Percent of Participants Reaching Monotherapy
timeFrame: Baseline through Month 6 (or end of study)
measure: Percent of Participants That Reduced, Maintained and Increased Their Doses of New Antiepileptic Drugs (AED)
timeFrame: Baseline to Month 6 (or end of treatment)
measure: Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy
timeFrame: Baseline through Month 6 (or end of treatment)
measure: Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline to Month 6
measure: Change From Baseline to Month 6 in Quality of Life 10 Domains (QOLIE-10)
timeFrame: Baseline to Month 6
measure: Change From Baseline to Months 3 and 6 in Health Condition: Euro Quality of Life Scale (EQ-5D) Visual Analog Scale (VAS)
timeFrame: Baseline, Month 3, Month 6
measure: Change in Sleep Disturbances From Baseline to Month 6: Medical Outcomes Study Sleep Scale (MOS-SS)
timeFrame: Baseline to Month 6
measure: Percent of Participants Indicating Optimal Sleep on the Optimal Sleep Subscale: Medical Outcomes Study Sleep Scale (MOS-SS)
timeFrame: Baseline, Month 6
measure: Change From Baseline to Month 6 in Visits to a Specialist or the Emergency Room Because of Epilepsy
timeFrame: Baseline to Month 6
measure: Change From Baseline to Month 6 in Total Number of Days Hospitalized Because of Epilepsy
timeFrame: Baseline to Month 6
measure: Percent of Participants With Cessation of Occupation, Requirement of Caregiver, or Admission to Intensive Care Unit
timeFrame: Month 6
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: