A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Focal Epilepsy |
Intervention | Drug: Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide |
Phase | Phase 4 |
Sponsor | Pfizer |
Responsible Party | Pfizer |
ClinicalTrials.gov Identifier | NCT00855738 |
First Received | March 3, 2009 |
Last Updated | November 23, 2010 |
Last verified | November 2010 |
Tracking Information[ + expand ][ + ]
First Received Date | March 3, 2009 |
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Last Updated Date | November 23, 2010 |
Start Date | May 2007 |
Estimated Primary Completion Date | June 2009 |
Current Primary Outcome Measures | Percent of Participants Classified as Responders [Time Frame: Baseline, Month 3, Month 6 (last 3 months of treatment)] [Designated as safety issue: No]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). |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice |
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Official Title | 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 | Interventional |
Study Phase | Phase 4 |
Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Focal Epilepsy |
Intervention | 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 Names: Neurontin, Lamictal, Lyrica, Keppra, Topamax, Gabatril, Episen, Zonegran |
Study Arm (s) | Other: 1.0 |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 111 |
Estimated Completion Date | June 2009 |
Estimated Primary Completion Date | June 2009 |
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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00855738 |
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Other Study ID Numbers | A0081144 |
Has Data Monitoring Committee | Yes |
Information Provided By | Pfizer |
Study Sponsor | Pfizer |
Collaborators | Not Provided |
Investigators | Study Director: Pfizer CT.gov Call Center Pfizer |
Verification Date | November 2010 |