E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 | 6.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034089 |
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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 trial are to evaluate the safety and tolerability of SPM 927 when given as iv infusions in subjects who are receiving oral SPM 927 in addition to up to 3 concomitant AEDs for partial seizures with or without secondary generalization. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent. 2. Subject has, in the opinion of the investigator, adequate seizure control for participation in the trial, and is willing and able to comply with all trial requirements including hospitalization, multiple blood draws and intravenous infusions. 3. Subject is currently enrolled in an open-label extension trial receiving oral SPM 927 for the treatment of partial seizures and has been enrolled for at least 8 weeks. 4. Subject has been on a stable bid dosage regimen between 200mg/day and 600mg/day SPM 927, inclusive, for the last 2 weeks. 5. Subject has been on a stable bid dosage regimen of 700 or 800mg/day SPM 927 for the last 2 weeks. Applicable only if doses above 600mg/day are allowed (see Section 11.1.5.2). 6. Subject has been on a stable dose of concomitant AED(s) for the last 2 weeks. 7. Subject has had stable VNS settings for the last 2 weeks, if applicable SPM 927. |
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E.4 | Principal exclusion criteria |
1. Subject is receiving any investigational drugs or using any experimental devices other than SPM 927. 2. Subject has previously received iv SPM 927. 3. Subject meets the withdrawal criteria for the open-label extension trial. 4. Subject has any medical or psychiatric condition that, in the opinion of the investigator, would compromise the subject’s ability to participate in this trial or possibly confound interpretation of the data. 5. Subject has diastolic blood pressure less than 50mm Hg or greater than 105mm Hg or heart rate less than 50 beats per minute (bpm) or greater than 110bpm, measured in a supine position after 3 minutes at rest. 6. Subject has a history of any kind of status epilepticus within the 12-month period prior to trial entry. 7. Subject has confirmed clinically relevant abnormality by ECG.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary variables are AEs as well as the results of vital signs monitoring, ECGs, clinical laboratory tests, physical examination, and neurological examination. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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The end of the trial is defined as the last telephone contact of the last subject. |
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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 | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 14 |