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

January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: 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 Names:
  • Neurontin, Lamictal, Lyrica, Keppra, Topamax, Gabatril, Episen, Zonegran

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline, Month 3, Month 6 (last 3 months of treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 3, Month 6 (last 3 months of treatment)
Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation
Time Frame: Baseline, Month 3, Month 6 (last 3 months of treatment)
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)
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.
Baseline through Month 6 (or end of treatment)
Time to First Seizure
Time Frame: Baseline to Month 6 (or end of treatment)
Number of days to first seizure after baseline.
Baseline to Month 6 (or end of treatment)
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.
Baseline to Month 6
Time to Discontinuation Due to Lack of Efficacy
Time Frame: Baseline, Month 3, Month 6
Baseline, Month 3, Month 6
Time to Discontinuation Due to Safety, Tolerability, or Treatment Compliance
Time Frame: Baseline, Month 3, Month 6
Baseline, Month 3, Month 6
Time to Discontinuation Due to Other Reasons
Time Frame: Baseline, Month 3, Month 6
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).
Baseline, Month 3, Month 6
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.
Baseline through Month 6 (or 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)
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)
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.
Baseline to Month 6
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.
Baseline to Month 6
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.
Baseline, Month 3, Month 6
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).
Baseline to Month 6
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.
Baseline, Month 6
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.
Baseline to Month 6
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.
Baseline to Month 6
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).
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2009

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A0081144
  • LICEO STUDY

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