A RANDOMIZED, COMPARATIVE, DOUBLE-BLIND, PARALLEL-GROUP, MULTICENTER, MONOTHERAPY, STUDY OF PREGABALIN LYRICA AND LAMOTRIGINE LAMICTAL IN PATIENTS WITH NEWLY DIAGNOSED PARTIAL SEIZURES - ND

• Conditions: Epilepsy; monotherapy in patients newly diagnosed with partial seizures with or without secondary generalization; MedDRA version: 8.1Level: LLTClassification code 10061334Term: Partial seizures

• Registration Number: EUCTR2005-004023-19-IT
• Lead Sponsor: PFIZER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. Diagnosis. The diagnosis of epilepsy must be established by the patient s history, neurological examination, and family history excluding confounding disorders such as pseudoseizures and syncope . An EEG must be performed during the baseline period or have been performed within 3 months prior to randomization. An MRI scan or CT scan with contrast is required during the baseline period or within 6 months prior to randomization; 2. Patients must have had at least 2 partial seizures 2 complex partial CP , 1 CP, and 1 secondarily generalized tonic clonic SGTC or 2 SGTC . Seizures are classified according to the International League against Epilepsy Classification of Seizures ; 3. Seizures should not have occurred within 2 weeks of an acute neurological event eg, a stroke ; 4. Patients with nocturnal seizures may be included if there is evidence of an epileptic focus on either EEG, CT, or MRI scan; 5. Patients must either be na ve to AED treatment or be treated with a suboptimal dose of a single AED for less than 14 days prior to screening Visit 1 ; 6. Male or female patients must be 18 years of age or over and weigh more than 40 kg; 7. Women must be non-pregnant and non-lactating, and must be premenarchal, postmenopausal, surgically sterilized, or using a barrier or hormonal method of contraception. All women must have a negative serum pregnancy test at screening; 8. Have a 12-lead ECG at Screening without significant abnormal findings see Section 7.2.4 ; 9. A written informed consent signed by the patient or parent/legal guardian must be provided prior to undergoing screening tests and any study related procedures; and 10. Patients must be reliable, cooperative and in the opinion of the investigator likely to be compliant with study procedures. They, or their reliable observer s , must be thought able to document the occurrence of seizures, along with a record of doses of study medication taken, in a daily diary.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. A treatable cause of seizures eg, identified etiologies including metabolic, neoplastic or active infectious origin; 2. Primary generalized seizures, which include Clonic, tonic, and tonic-clonic seizures; Absence seizures; Myoclonic seizures; Reflex epilepsies; 3. Lennox Gastaut syndrome; 4. Reported status epilepticus SE ; 5. Seizures related to head trauma within the last month preceding V1; 6. Situation related seizures or pseudoseizures; 7. Progressive neurologic or systemic disorder; 8. WBC count 2500/mm3; neutrophil count of 1500/mm3; platelet count of 100 103 /mm3; 9. A history or clinical evidence of cardiovascular, hematologic, hepatic or renal disease ALT, aspartate aminotransferase AST , bilirubin or urea of greater than twice the upper limit of normal ULN at screening ; 10. Creatinine clearance CLcr / 60 mL/min as estimated from serum creatinine using Cockcroft and Gault equation. 11. Significant psychiatric disorder or recurrent episodes of severe depression any pharmacologic treatment or hospitalization for the illness within 12 months prior to screening . Patients with mild chronic depression, without a history of recent hospitalization, who are being maintained on a stable dose of a single antidepressant are acceptable; 12. Received any investigational drugs within 3 months prior to V1; 13. Taking any concomitant medication that could alter the effectiveness of the study drug; 14. A history of drug or alcohol abuse; 15. Are pregnant, breast-feeding, or intend to become pregnant during the course of the study; 16. Those taking valproic acid products within the 2 weeks preceding V1; 17. Use of a vagal nerve stimulator; and/or 18. Prior use of pregabalin or lamotrigine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of pregabalin as a monotherapy treatment compared with lamotrigine both administered twice daily BID in patients with newly diagnosed partial seizures.;Secondary Objective: To assess the safety and tolerability of pregabalin monotherapy compared with lamotrigine.;Primary end point(s): The proportion of patients who are seizure-free for a minimum period of 6 months during the 52-week double-blind efficacy assessment phase excluding the initial dose escalation for both treatment arms to reach target Level 1 and excluding the taper or extension phases .