Epilepsy - Primary genralised tonic clonic seizures
Conditions
Interventions
Product Name: Lamotrigine extended release
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Lamotrigine
CAS Number: 84057-84-1
Concentration unit: mg milligram(s)
Concentration number
Sponsors
GlaxoSmithKline Research and Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is = 13 years of age (male or female). 2. Has a confident diagnosis of epilepsy with PGTC seizures for more than 24 weeks prior to the Baseline Phase. 3. Has EEG evidence of either spike-and-wave discharges consistent with PGTC, or at least 2 EEGs with no indication of focal abnormalities. The EEG may be historical or prospective. Investigators may use a historical EEG as long as there is appropriate documentation. 4. Has a documented history of PGTC seizures with or without other generalized seizure type(s) with no focal onset, and at least 1 PGTC seizure during the eight consecutive weeks (i.e., 56 consecutive days) prior to starting the 8-week Baseline Phase. 5. Has at least 3 PGTC seizures occurring anytime during an 8-week (i.e., 56 days) prospective Baseline Phase. 6. Is currently treated with a stable regimen of one or two AED(s) for at least four weeks prior to starting the Baseline Phase (historical or prospective). 7. Is able and willing to maintain an accurate and complete daily written seizure diary, or has a parent/caregiver who is able and willing to maintain an accurate and complete daily written seizure diary for the entire duration of the study. 8. Is able to comply with dosing of study drugs, background AEDs and all study procedures. 9. Has given written informed consent, or has a parent/legally authorized representative who has given written informed consent, prior to the performance of any study assessments. 10. If female, and of childbearing potential, must be using an acceptable form of birth control, to include one of the following: a. Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (a minimum of 3 weeks). b. Consistent and correct use of one of the following methods of birth control: • Male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for that female subject • Implants of levonorgestrel • Injectable progestogen • Oral contraceptive (either combined, with at least 50µg estrogen for women on EIAEDs, or progestogen only) • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year • Double barrier method consisting of spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm). Are the trial subjects under 18? yes 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
Exclusion criteria: 1. Has a history of partial seizures or interictal expression of partial seizures as evidenced by EEG (see Section 14.1, “Appendix 1: Algorithm to Exclude Subjects with Partial Seizures 2. Has had status epilepticus within the 24 weeks prior to, or during, the Baseline Phase. 3. Is taking three or more background AEDs chronically. 4. Has Lennox-Gastaut syndrome. 5. Is currently using or has previously used lamotrigine. 6. Is currently taking felbamate. 7. Is abusing alcohol and/or other substance(s). 8. Has taken an investigational drug within the previous 30 days or plans to take an investigational drug anytime during the study. 9. Is receiving chronic treatment with any medication that could influence seizure control. 10. Is currently following the ketogenic diet. 11. Is planning surgery to control seizures during the study. 12. Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormality that are likely to interfere with the objectives of the study. 13. Has any clinically significant cardiac, renal, hepatic condition, or a condition that affects the absorption, distribution, metabolism or excretion of drugs. 14. Is pregnant, breastfeeding, or planning to become pregnant during the study or within the three weeks after the last dose of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of once daily adjunctive therapy with LTG extended-release in subjects with PGTC seizures;Secondary Objective: • To evaluate the safety and tolerability of adjunctive therapy with LTG extended-release in subjects with PGTC seizures. • To evaluate the effect of adjunctive therapy with LTG extended-release on mood and quality of life in this population. • To characterize the population pharmacokinetics of lamotrigine in subjects with PGTC seizures and to assess the presence of pharmacokinetic/pharmacodynamic relationship between systemic lamotrigine exposure and clinical outcome. ;Primary end point(s): Percent change from Baseline in PGTC seizure frequency during the entire Double-Blind Treatment Phase. | — |
Countries
Germany
Outcome results
None listed