Back to resultsA Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
Primary Purpose
Focal Epilepsy
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide
Sponsored by
About this trial
This is an interventional treatment trial for Focal Epilepsy focused on measuring epilepsy antiepileptic biotherapy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1.0
Arm Description
Outcomes
Primary Outcome Measures
Percent of Participants Classified as Responders
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
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
Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment
Percent of Days Without Crisis During the Study
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
Number of days to first seizure after baseline.
Percent of Participants Who Continued on Study Medication 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 to Discontinuation Due to Safety, Tolerability, or Treatment Compliance
Time to Discontinuation Due to Other Reasons
Treatment Satisfaction Evaluated by Patient Global Impression of Change Visual Analog Scale (VAS)
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
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)
Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy
Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS)
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)
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)
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)
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)
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
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
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
Percent of participants with cessation of usual occupation, requirement of an informal caregiver, and who required admission to the intensive care unit (ICU).
Full Information
NCT ID
NCT00855738
First Posted
March 3, 2009
Last Updated
January 21, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00855738
Brief Title
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
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Epilepsy
Keywords
epilepsy antiepileptic biotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1.0
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide
Other Intervention Name(s)
Neurontin, Lamictal, Lyrica, Keppra, Topamax, Gabatril, Episen, Zonegran
Intervention Description
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
Primary Outcome Measure Information:
Title
Percent of Participants Classified as Responders
Description
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).
Time Frame
Baseline, Month 3, Month 6 (last 3 months of treatment)
Secondary Outcome Measure Information:
Title
Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment
Description
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.
Time Frame
Baseline, Month 3, Month 6 (last 3 months of treatment)
Title
Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation
Time Frame
Baseline, Month 3, Month 6 (last 3 months of treatment)
Title
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)
Title
Percent of Days Without Crisis During the Study
Description
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 Frame
Baseline through Month 6 (or end of treatment)
Title
Time to First Seizure
Description
Number of days to first seizure after baseline.
Time Frame
Baseline to Month 6 (or end of treatment)
Title
Percent of Participants Who Continued on Study Medication to Month 6
Description
Retention rate: percent of participants who continued on study medication throughout the 6 Month period after inclusion in the study.
Time Frame
Baseline to Month 6
Title
Time to Discontinuation Due to Lack of Efficacy
Time Frame
Baseline, Month 3, Month 6
Title
Time to Discontinuation Due to Safety, Tolerability, or Treatment Compliance
Time Frame
Baseline, Month 3, Month 6
Title
Time to Discontinuation Due to Other Reasons
Time Frame
Baseline, Month 3, Month 6
Title
Treatment Satisfaction Evaluated by Patient Global Impression of Change Visual Analog Scale (VAS)
Description
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).
Time Frame
Baseline, Month 3, Month 6
Title
Percent of Participants Reaching Monotherapy
Description
Percent of participants who started on more than one treatment (bitherapy) and reached monotherapy by end of study.
Time Frame
Baseline through Month 6 (or end of study)
Title
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)
Title
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)
Title
Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Baseline to Month 6
Title
Change From Baseline to Month 6 in Quality of Life 10 Domains (QOLIE-10)
Description
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.
Time Frame
Baseline to Month 6
Title
Change From Baseline to Months 3 and 6 in Health Condition: Euro Quality of Life Scale (EQ-5D) Visual Analog Scale (VAS)
Description
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.
Time Frame
Baseline, Month 3, Month 6
Title
Change in Sleep Disturbances From Baseline to Month 6: Medical Outcomes Study Sleep Scale (MOS-SS)
Description
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).
Time Frame
Baseline to Month 6
Title
Percent of Participants Indicating Optimal Sleep on the Optimal Sleep Subscale: Medical Outcomes Study Sleep Scale (MOS-SS)
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline to Month 6 in Visits to a Specialist or the Emergency Room Because of Epilepsy
Description
Numerical assessment of change in the number of visits to a specialist or the emergency room because of epilepsy needed during the study.
Time Frame
Baseline to Month 6
Title
Change From Baseline to Month 6 in Total Number of Days Hospitalized Because of Epilepsy
Description
Numerical assessment of change in total number of days hospitalized because of epilepsy during the study.
Time Frame
Baseline to Month 6
Title
Percent of Participants With Cessation of Occupation, Requirement of Caregiver, or Admission to Intensive Care Unit
Description
Percent of participants with cessation of usual occupation, requirement of an informal caregiver, and who required admission to the intensive care unit (ICU).
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081144&StudyName=A%20Prospective%2C%20Observational%20Study%20On%20The%20Effectiveness%20Of%20New%20Antiepileptic%20Drugs%20As%20First%20Bitherapy%20In%20The%20Daily%20Clinical%20Practice
Description
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Learn more about this trial
A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
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