E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Epilepsy; partial onset or generalized tonic clonic seizures |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10015037 |
E.1.2 | Term | Epilepsy |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 |
The objectives of this study are:
• To obtain information about the long term safety of Lacosamide (LCM) in comparison with Carbamazepine Controlled Release (CBZ CR) when used as monotherapy in subjects with recently diagnosed partial onset or generalized tonic clonic seizures
• To allow subjects who completed the monotherapy study SP0993 to continue to receive LCM or CBZ CR
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E.2.2 | Secondary objectives of the trial |
See section 4.1.2 and 4.2 of the protocol. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject or by the parent(s) or legal representative. The Informed Consent form or a specific Assent form, where required, will be signed and dated by minors.
2. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator.
3. Subject has remained seizure free and completed the Maintenance Phase of the SP0993 monotherapy study; or subject has experienced 1 or more seizures on the first or second target dose (ie second target does without dose reduction) during the SP0993 Maintenance Phase; or subject has been transferred from SP0993 to SP0994 as a result of
SP0993 Protocol Amendment 6.2 (Bulgaria , Canada, Germany, Japan,
Latvia, Lithuania, Mexico, Philippines, Romania, Russia, Slovakia, South Korea, Sweden, Ukraine, United States)
4. Subject is expected to benefit from participation in SP0994 in the opinion of the investigator. |
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E.4 | Principal exclusion criteria |
1. Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM) or Cabamazepine Controlled Release (CBZ CR).
2. Subject experienced a seizure at the third target dose during the Evaluation Phase or Maintenance Phase of the SP0993 study.
3. Subject is taking benzodiazepines for a nonepilepsy indication. Benzodiazepines as rescue therapy for epilepsy may be used as needed, but not more frequently than once per week.
4. Subject meets a withdrawal criterion (ie, 'must withdraw') (other than the criterion of a seizure during the Maintenance Phase at the first or second target dose without dose reduction) for the previous study SP0993.
5. Subject is experiencing an ongoing SAE from the previous study SP0993.
6. For France, subject is covered by a judicial protection measure (ie, articles L.1121-6 and
L.1121-8 of the French Public Health Code).
7. Subject has a lifetime history of suicide attempt (including an active attempt, interrupted
attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by
a positive response (Yes) to either Question 4 or Question 5 of the Columbia Suicide
Severity Rating Scale (C-SSRS) at Screening. Or subject has a positive response (Yes) to
either Question 4 or Question 5 of the C-SSRS at Screening in the “Since Last Visit”
version.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary safety variables are as follows:
• AEs reported spontaneously by the subject and/or caregiver or observed by the investigator
• Subject withdrawals due to AEs
• SAEs
The exploratory efficacy variables are:
• Percentage of subjects seizure free
• Time to discontinuation
The exploratory health outcomes variables are:
• Health care resource use: Additional health care provider visits unforeseen by the protocol and hospitalizations |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The other safety variables are as follows:
• Changes in hematology, chemistry, and urinalysis parameters
• Changes in 12-lead electrocardiograms (ECGs)
• Changes in vital sign measurements (ie, blood pressure [BP] and pulse rate)
• Changes in physical or neurological examination findings
• Changes in body weight |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
After database lock of SP0993, SP0994 will be unblinded. Open label acces according to law. |
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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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 115 |
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 |
Australia |
Canada |
European Union |
Russian Federation |
Ukraine |
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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 | 6 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
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 | 0 |