Phase 3
Completed N=621
Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.
Painful Diabetic Neuropathy
Source: ClinicalTrials.gov NCT00546351 ↗
Enrolled (actual)
621
Serious AEs
21.3%
Results posted
Apr 2012
Primary outcomePrimary: 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). — 416 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
416 | — |
| PRIMARY 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). |
132 | — |
| SECONDARY Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit. |
6.45 | — |
| SECONDARY Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit. |
3.01 | — |
| SECONDARY Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline. |
65.83 | — |
| SECONDARY Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit. |
30.47 | — |
| SECONDARY Patient's Global Impression of Change (PGIC) at Last Visit. |
82.6; 11.4; 6.0 | — |
| SECONDARY Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit. |
-3.2 | — |
| SECONDARY Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit. |
3.0 | — |
| SECONDARY Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit. |
2.9 | — |
| SECONDARY Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit. |
2.1 | — |
| SECONDARY Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit. |
2.9 | — |
| SECONDARY Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit. |
3.8 | — |
| SECONDARY Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit. |
3.2 | — |
| SECONDARY Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit. |
3.4 | — |
| SECONDARY Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit. |
2.0 | — |
| SECONDARY Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit. |
2.9 | — |
| SECONDARY Average Pain Interference With Sleep (11-point Likert Scale) at Baseline. |
5.98 | — |
| SECONDARY Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit. |
2.73 | — |
| SECONDARY Average Pain Interference With Activity (11-point Likert Scale) at Baseline. |
6.11 | — |
| SECONDARY Average Pain Interference With Activity (11-point Likert Scale) at Last Visit. |
2.89 | — |
| SECONDARY Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline. |
32.8 | — |
| SECONDARY Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit. |
38.4 | — |
| SECONDARY Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline. |
42.8 | — |
| SECONDARY Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit. |
44.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00546351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.