Painful Diabetic Neuropathy
Conditions
Keywords
Lacosamide, Vimpat®
Brief summary
The primary objective of the trial is to assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy.
Interventions
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
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Quality of life assessments during specific site visits | 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 |
| 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 |
Outcome results
None listed