E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Painful distal diabetic neuropathy |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012680 |
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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 primary objective of the trial is to assess the tolerability and safety of long-term lacosamide administratíon in subjects with painful distal diabetic neuropathy. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the efficacy of long-term use of lacosamide in this indication. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
A DOUBLE-BLIND, RANDOMIZED WITHDRAWAL OF LACOSAMIDE IN SUBJECTS WITH PAINFUL DIABETIC NEUROPATHY-SUBTRIAL TO SP746
Protocol Amendment 2: 19 May 2006
The primary objective of this subtrial is to demonstrate the efficacy of lacosamide in subjects with painful diabetic neuropathy who have been treated longterm with lacosamide. Secondary objectives include assessment of additional efficacy parameters and an evaluation of the effects of withdrawal on the safety of lacosamide. |
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E.3 | Principal inclusion criteria |
A subject is considered eligible for participation in the trial if the following inclusion criteria are satisfied:
1. Subject is informed and has been given ample time and opportunity to think about her/his participation and has given her/his written informed consent. Note: subjects completing the double-blind trial must provide written informed consent at the start of the Transition Phase (Visit 9 of SP743 or Visit 8 of SP874).
2. Subject has completed SP743 or SP874 and, in the investigator’s opinion, might benefit from long-term administration of lacosamide. Exception: subjects who prematurely discontinued SP743 or SP874 due to lack of efficacy or due to intolerability to trial medication (after Visit 5 but prior to entering the Maintenance Phase) may be eligible to participate in SP746, after consultation with the medical monitor.
3. Subject is willing and able to comply with all trial requirements, including the completion of trial questionnaires. |
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E.4 | Principal exclusion criteria |
A subject is not eligible for participation in the trial if any of the following exclusion criteria are met.
1. Subject has clinically relevant ECG abnormalities, or a QTc interval ≥500ms, and/or a QTc interval increase of ≥60ms from the mean pre-dose QTc value at Visit 2 of SP743 or SP874.
2. Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥3 times the upper limit of the normal range (ULN) with total bilirubin ≥2 times ULN or transaminases (AST and/or ALT) ≥5 times ULN.
3. Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject’s ability to participate in this trial.
4. Subject is a pregnant or nursing female, or is of childbearing potential and is not surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of contraception.
5. Subject has hypersensitivity to components of the trial medication.
6. Subject has previously participated in this or any other follow-on trial of lacosamide.
7. Subject has participated in another trial of an investigational drug or device within the last 30 days (except the prerequisite lacosamide trials) or is currently participating in another trial of an investigational drug or device.
8. Subject has an ongoing serious adverse event (SAE) assessed to be related to the trial medication either by the investigator or the sponsor.
9. Subject has sick sinus syndrome and does not have a pacemaker.
10. Subject has atrial fibrillation/flutter, ventricular tachyarrhythmia (eg, ventricular tachycardia, ventricular fibrillation, aborted cardiac arrest), symptomatic heart block at Visit 1, or is diagnosed with Brugada syndrome.
11. Subject has diagnosis of New York Heart Association Class III or Class IV heart failure. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Adverse events reported spontaneously by the subject or observed by the investigator.
2. Changes in hematology, clinical chemistry, and urinanalysis parameters.
3. Changes in vital sign measurements and physical (including neurological) examination findings.
4. Changes in 12-lead ECGs.
5. Subject withdrawals due to adverse events.
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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 | 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.8.3 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 83 |
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 | Yes |
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 date of the last visit of the last patient 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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |