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

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NCT00855738

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Focal Epilepsy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Focal EpilepsyA Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
NCT00855738
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 Allocation: N/A
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 CenterPfizer
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