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

Phase 1

• Conditions: Epilepsy; Patients with newly diagnosed partial seizures (with or without secondary generalization); MedDRA version: 9.1Level: LLTClassification code 10061334Term: Partial seizures

• Registration Number: EUCTR2005-004023-19-SK
• Lead Sponsor: Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United Kingdom

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-30
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

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

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial
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 within the past 12 months, with at least one occurring in the past 6 months. Seizures may be of the following types: 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 naïve to AED treatment or be treated with a single AED for less than 14 days prior to screening (Visit 1);
6. Male or female patients must be 16 years of age or older or consistent with local
regulations 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; 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

Subjects presenting with any of the following will not be included in the trial:

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 × 10 /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