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

NCT00855738 | Completed Phase 4 Results DMC

• 2 other identifiers: A0081144LICEO STUDY
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Focal Epilepsy

Keywords

epilepsy antiepileptic biotherapy

Outcome Measures

Primary Outcomes (1)

• Percent of Participants Classified as Responders

  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).

  Baseline, Month 3, Month 6 (last 3 months of treatment)

Secondary Outcomes (21)

• Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment

  Baseline, Month 3, Month 6 (last 3 months of treatment)

• Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation

  Baseline, Month 3, Month 6 (last 3 months of treatment)

• Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment

  Baseline, Month 3, Month 6 (last 3 months of treatment)

• Percent of Days Without Crisis During the Study

  Baseline through Month 6 (or end of treatment)

• Time to First Seizure

  Baseline to Month 6 (or end of treatment)

Study Arms (1)

1.0

OTHER

Drug: Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide

Interventions

Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide DRUG

* 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

Also known as: Neurontin, Lamictal, Lyrica, Keppra, Topamax, Gabatril, Episen, Zonegran

1.0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Gabapentin; Lamotrigine; Levetiracetam; Pregabalin; Tiagabine; Topiramate; Zonisamide

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetamides; Amides; Acetates; Pyrrolidinones; Pyrrolidines; Nipecotic Acids; Acids, Heterocyclic; Piperidines; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Sulfonamides; Sulfones; Sulfur Compounds; Isoxazoles; Azoles

Limitations and Caveats

This study was cancelled with 111 patients enrolled due to lack of recruitment, and inability to analyze the study by treatment groups. Seizures were analyzed by 3 month data instead of 2 month data as originally planned.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 4, 2009
• Study Start: May 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 25, 2021
• Results First Posted: July 23, 2010

Record last verified: 2010-11