A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
NCT00855738
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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 | ||||
|---|---|---|---|---|
| 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:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||