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

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NCT00855738

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT00855738
Pfizer
Completed
A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice

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A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Focal Epilepsy
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
1.0
Intervention: Drug: Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
June 2009
June 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00855738
A0081144
LICEO STUDY
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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