| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Epilepsy; Patients with newly diagnosed partial seizures (with or without secondary generalization) |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 8.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10061334 |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
1. To evaluate the efficacy of pregabalin as a monotherapy treatment compared with lamotrigine, both administered BID, in patients with newly diagnosed partial seizures.
2. To assess the safety and tolerability of pregabalin monotherapy compared with lamotrigine.
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| E.2.2 | Secondary objectives of the trial |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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: simple partial [SP], complex partial [CP], or secondarily generalized tonic clonic [SGTC]. Seizures are classified according to the International League against Epilepsy Classification of Seizures26 (Appendix 2);
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.
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| E.4 | Principal 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 2 weeks 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. (See Appendix 1);
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. Women taking an oral contraceptive prior to study entry are acceptable;
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 1 week of V2;
17. Use of a vagal nerve stimulator; and/or
18. Prior use of pregabalin or lamotrigine.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| The proportion of patients who are seizure-free for a minimum period of 6 continuous 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). |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 90 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 3 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 10 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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