E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic generalized epilepsy |
|
E.1.1.1 | Medical condition in easily understood language |
Idiopathic generalized epilepsy |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
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 |
The primary objective is to assess the safety and tolerability of LCM as an adjunctive therapy for uncontrolled PGTC seizures in subjects with IGE during long-term exposure. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are:
- To assess the efficacy of adjunctive LCM therapy during long-term exposure for the treatment of subjects with IGE experiencing uncontrolled PGTC seizures
- To allow subjects who have completed SP0982 and eligible Baseline failures from SP0982 to receive LCM |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subject must have completed or be an eligible Baseline failure from the parent study SP0982
Note: Other subjects screened for SP0982 may be considered for rollover to EP0012 if the investigator considers that the subject could
benefit from treatment with open-label lacosamide and based on prior discussion with and approval from the UCB Study Physician or
representative
|
|
E.4 | Principal exclusion criteria |
1. Subject is receiving any investigational drugs or using any experimental devices in addition to LCM.
2. Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE).
3. Subject has an active suicidal ideation as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the “Since Last Visit” version of the Columbia-Suicide Severity Rating Scale (C-SSRS). The subject should be referred immediately to a Mental Healthcare Professional.
4. Subject has >=2x upper limit of normal (ULN) of any of the following:
alanine aminotransferase (ALT), aspartate aminotransferase (AST),
alkaline phosphatase (ALP), or >ULN total bilirubin (1.5xULN total
bilirubin if known Gilbert's syndrome). If subject has elevations only in
total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to
identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin
<35%).
5. For all subjects who entered EP0012 directly with a Baseline result >ULN
for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the
cause of any clinically meaningful elevation must be understood and
recorded in the electronic Case Report form (eCRF). Tests that result in
ALT, AST, or ALP up to 25% above the exclusion limit may be repeated
once for confirmation. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Number of subjects with treatment-emergent adverse events (TEAEs) over the duration of the Treatment Period
2. Number of subjects withdrawn due to TEAEs
3. Number of subjects with new appearance of absence and/or
myoclonic seizures during the Treatment Period
4. Number of subjects with an increase of up to 25% in days with
absence seizures per 28 days compared to the Prospective Baseline (of study SP0982)
5. Number of subjects with an increase of >25% to 50% in days with
absence seizures per 28 days compared to the Prospective Baseline (of study SP0982)
6. Number of subjects with an increase of >50% to 75% in days with
absence seizures per 28 days compared to the Prospective Baseline (of study SP0982)
7. Number of subjects with an increase of >75% in days with absence
seizures per 28 days compared to the Prospective Baseline (of study SP0982)
8. Number of subjects with an increase of up to 25% in days with
myoclonic seizures per 28 days compared to the Prospective Baseline (of study SP0982)
9. Number of subjects with an increase of >25% to 50% in days with
myoclonic seizures per 28 days compared to the Prospective Baseline (of study SP0982)
10. Number of subjects with an increase of >50% to 75% in days with
myoclonic seizures per 28 days compared to the Prospective Baseline (of study SP0982)
11. Number of subjects with an increase of >75% in days with myoclonic seizures per 28 days compared to the Prospective Baseline (of study SP0982)
12. Percentage of subjects with at least 50% worsening in days with
absence seizures
13. Percentage of subjects with at least 50% worsening in days with
myoclonic seizures |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. - 3. During the Treatment Period (up to 5 years)
4. - 13. From Visit 1 to End of Treatment Period (up to 5 years) |
|
E.5.2 | Secondary end point(s) |
1. Percentage of treatment-emergent marked abnormalities in
hematology parameters
2. Percentage of treatment-emergent marked abnormalities in chemistry parameters
3. Percentage of treatment-emergent marked abnormalities in 12-lead
electrocardiogram (ECGs)
4. Percentage of treatment-emergent marked abnormalities in vital sign measurements
5. Percent change in Primary Generalized Tonic-clonic seizure (PGTCS)
frequency per 28 days from Combined Baseline |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. - 4. During the study (up to 5 years)
5. From Combined Baseline until Termination Visit (up to 5 years) |
|
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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
|
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 80 |
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 | No |
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 |
Australia |
Belgium |
Brazil |
Bulgaria |
China |
Czechia |
France |
Germany |
Hungary |
Israel |
Italy |
Japan |
Korea, Republic of |
Mexico |
Poland |
Portugal |
Romania |
Russian Federation |
Slovakia |
Spain |
Taiwan |
Turkey |
United States |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 8 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 2 |
E.8.9.2 | In all countries concerned by the trial years | 8 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 2 |