An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy

Study Overview
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Brief Summary
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The primary objective of the trial is to assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy.

Official Title
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An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy

Conditions
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Painful Diabetic Neuropathy

Intervention / Treatment
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* Drug: SPM927/Lacosamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has successfully completed a previous trial with SPM 927 in diabetic neuropathy and, in the investigator's opinion, would benefit from long-term administration of SPM 927. Subject has stable, good or fair diabetic control (HbA1c ≤10% ). Exclusion Criteria: Subject has other conditions that cause neuropathic pain at least as severe as the diabetic pain, i.e. peripheral arterio-vascular disease. Subject receives treatment for seizures. Subject has had an amputation related to diabetes, other than toe amputation. Subject has major skin ulcers. Subject has clinically significant ECG abnormalities. Subject expects to take during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, skeletal muscle relaxants, benzodiazepines or over-the-counter medications with centrally acting properties. Subject has laboratory values which are outside the normal range and judged by the investigator to be clinically significant. Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin, or GGT) ≥ 2x ULN at Visit 1. At Visit 1, subject has impaired renal function, i.e., creatinine clearance (ClCr) is lower than 60 mL/min.
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: 1<br> | Drug: SPM927/Lacosamide<br>* SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation<br>* Other names: SPM927 / Lacosamide / Vimpat®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy |  | Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits | 
| Adverse events reported spontaneously by the subject or observed by the investigator |  | Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits. | 
| Changes laboratory, ECG and vital signs parameters. |  | Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits. | 
| Changes in physical or neurological examination findings |  | Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits. | 
| Subject withdrawal due to adverse events |  | Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective is to gather further information on the efficacy of SPM 927 in this indication. |  | Daily assessment during entire trial participation including assessments at site visits | 
| Within-subject change in average pain score: Daily assessments throughout the trial |  | Daily assessment during entire trial participation including assessments at site visits | 
| Change in subject's perception of different neuropathic pain qualities during specific site visit |  | Daily assessment during entire trial participation including assessments at site visits | 
| Time to exit (days) de to lack of efficacy of treatment |  | Daily assessment during entire trial participation including assessments at site visits | 
| Change in subject's perception of sleep and activity throughout the trial, daily assessments |  | Daily assessment during entire trial participation including assessments at site visits | 
| Patient's Global Impression of Change in Pain (PGIC) during specific site visit |  | Daily assessment during entire trial participation including assessments at site visits | 
| Clinical Global Impression of Change in Pain (CGIC): Assessments during specific site visit |  | Daily assessment during entire trial participation including assessments at site visits | 
| Quality of life assessments during specific site visits |  | Daily assessment during entire trial participation including assessments at site visits | 

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