Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.

Study Overview
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Brief Summary
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SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy.

Official Title
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A Multi-center, Open-label, follow-on Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Including a Double-blind, Randomized Time Point Withdrawal Subtrial.

Conditions
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Painful Diabetic Neuropathy

Intervention / Treatment
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* Drug: Lacosamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who completed Study SP743 (NCT00238524) or SP874 (NCT00350103) and, in the investigator's opinion, might benefit from long-term administration of SP746 (NCT00546351). Exception: subjects who prematurely discontinued SP743 (NCT00238524) or SP874 (NCT00350103) due to lack of efficacy or due to intolerability to trial medication (after Visit 5but prior to entering the Maintenance Phase) may be eligible to participate in SP746 (NCT00546351), after consultation with the medical monitor Exclusion Criteria: Subject has clinically relevant ECG abnormalities, or a QTc interval ≥500 ms, and/or a QTc interval increase of ≥60 ms from the mean pre-dose QTc value at Visit 2 of SP743 (NCT00238524) or SP874 (NCT00350103) 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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lacosamide<br>50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years. | Drug: Lacosamide<br>* 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years<br>* Other names: Vimpat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years). | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | From entry Visit 1 through end of treatment (approximately 6.5 years) | 
| Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years). | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Is fatal Is life-threatening Results in persistent or significant disability/incapacity Requires inpatient hospitalization Prolongs existing inpatient hospitalization Is a congenital anomaly/birth defect Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above | From entry Visit 1 through end of treatment (approximately 6.5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit. | On the Likert Scale, 0 = no pain and 10 = worst possible pain. | Baseline | 
| Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit. | On the Likert Scale, 0 = no pain and 10 = worst possible pain. | Last Visit (approximately 2 years) | 
| Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline. | Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain. | Baseline | 
| Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit. | On VAS 0 mm = no pain and 100 mm = worst possible pain. | Last Visit (approximately 2 years) | 
| Patient's Global Impression of Change (PGIC) at Last Visit. | The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]). Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse). | Last Visit (approximately 2 years) | 
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit. | 0 = no pain and 10 = most intense pain sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) | 
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit. | 0 = not sharp and 10 = most sharp sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) | 
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit. | 0 = not hot and 10 = the most hot sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) | 
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit. | 0 = not cold and 10 = the coldest sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) | 
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit. | 0 = not dull and 10 = most dull sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) | 
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit. | 0 = not unpleasant and 10 = most unpleasant sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) | 
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit. | 0 = no surface pain and 10 = most intense surface pain imaginable. | Baseline Visit; Last Visit (approximately 2 years) | 
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit. | 0 = no deep pain and 10 = most intense deep pain imaginable. | Baseline Visit; Last Visit (approximately 2 years) | 
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit. | 0 = not itchy and 10 = most itchy sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) | 
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit. | 0 = not sensitive and 10 = most sensitive sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) | 
| Average Pain Interference With Sleep (11-point Likert Scale) at Baseline. | 0 = no interference with sleep and 10 = worst possible interference with sleep. | Baseline | 
| Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit. | 0 = no interference with sleep and 10 = worst possible interference with sleep. | Last Visit | 
| Average Pain Interference With Activity (11-point Likert Scale) at Baseline. | 0 = no interference with activity and 10 = worst possible interference with activity. | Baseline | 
| Average Pain Interference With Activity (11-point Likert Scale) at Last Visit. | 0 = no interference with activity and 10 = worst possible interference with activity. | Last Visit | 
| Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline. | The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score. | Baseline | 
| Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit. | The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score. | Last Visit | 
| Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline. | The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score. | Baseline | 
| Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit. | The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score. | Last Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lacosamide