Phase 3
N=451
A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
Diabetic Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT00235443 ↗Enrolled (actual)
451
Serious AEs
22.2%
Results posted
Oct 2009
Primary outcome: Primary: Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator. — 11; 52; 74; 196 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- lacosamide (Drug)
- Age
- Adult, Older Adult · 32+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator. |
11; 52; 74; 196; 33; 50 | — |
| SECONDARY Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10). |
-5.15; -4.30; -3.70; -3.29; -3.54; -2.73 | — |
| SECONDARY Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS). |
-47.83; -43.06; -35.24; -30.06; -36.73; -27.70 | — |
| SECONDARY Patient's Global Impression of Change (PGIC) From Baseline in Pain. |
10; 42; 50; 147; 26; 34 | — |
| SECONDARY Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity. |
-4.6; -4.4; -3.1; -2.7; -3.5; -2.0 | — |
| SECONDARY Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness |
-4.5; -4.2; -3.3; -2.8; -3.9; -1.9 | — |
| SECONDARY Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat |
-5.3; -3.0; -3.1; -2.6; -2.8; -1.2 | — |
| SECONDARY Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness |
-3.4; -2.6; -2.6; -2.4; -2.4; -1.8 | — |
| SECONDARY Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold |
-1.6; -1.9; -1.2; -1.7; -2.2; -0.5 | — |
| SECONDARY Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity |
-2.8; -3.4; -1.8; -2.1; -2.7; -1.4 | — |
| SECONDARY Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness |
-2.2; -2.0; -1.4; -1.1; -2.1; -0.5 | — |
| SECONDARY Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness |
-5.0; -4.0; -3.3; -2.9; -3.3; -1.5 | — |
| SECONDARY Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain |
-4.5; -3.3; -3.2; -2.7; -3.3; -1.5 | — |
| SECONDARY Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain |
-3.5; -3.3; -3.3; -2.6; -2.7; -1.5 | — |
| SECONDARY Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale) |
-4.62; -3.86; -3.32; -3.15; -3.34; -2.85 | — |
| SECONDARY Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale) |
-4.82; -3.82; -3.36; -3.00; -3.30; -2.54 | — |
| SECONDARY Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) |
3.3; 5.5; 5.1; 3.7; 3.5; 2.1 | — |
| SECONDARY Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) |
-3.4; -0.1; 0.7; -1.1; -3.7; -0.4 | — |
Summary
Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.
Eligibility Criteria
Inclusion Criteria
- Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion, might benefit from long-term administration of SPM 927. Exception: subjects who prematurely discontinued Study SP742 or SP768 due to lack of efficacy or due to intolerability to trial medication may be eligible to participate in Study SP745, after consultation with the medical monitor.
Exclusion Criteria
- Subject has clinically relevant electrocardiogram (ECG) abnormalities, or QT-corrected (QTc) interval >=500 milliseconds (ms), and/or a QTc interval increase of >=60ms from the mean pre-dose QTc value at Visit 2 of Studies SP665, SP742 or SP768.
- 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.
Data sourced from ClinicalTrials.gov (NCT00235443). 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.