A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
NCT00855738
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- 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.
- 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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Descriptive Information | ||||
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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
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 | 111 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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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 |