Painful distal diabetic neuropathy MedDRA version: 9.0 Level: LLT Classification code 10012680
Conditions
Interventions
Product Name: Lacosamide
Product Code: SPM 927
Pharmaceutical Form: Film-coated tablet
CAS Number: 175481-36-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
SCHWARZ BIOSCIENCES GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: The secondary objective is to evaluate the efficacy of long-term use of lacosamide in this indication.;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. | — |
Countries
Austria, Finland, Italy, Spain
Outcome results
None listed