Phase 3
N=551
A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy
Painful Diabetic Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT00350103 ↗Enrolled (actual)
551
Serious AEs
7.6%
Results posted
Mar 2024
Primary outcome: Primary: Change in Average Daily Pain Score From Baseline Week to the Last 4 Weeks of the Maintenance Phase — -1.9; -2.2; -2.4 units on a scale — p==0.0410
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SPM 929 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average Daily Pain Score From Baseline Week to the Last 4 Weeks of the Maintenance Phase |
-1.9; -2.2; -2.4 | =0.0410 sig |
| SECONDARY Time to Sustainable Pain Relief |
31.0; 11.0; 10.0 | — |
| SECONDARY Percentage of Subjects With >= 30% or >= 2-point Reduction of with-in Subject Change in Average Daily Pain Score From the Baseline Week to the Last 4 Weeks of the Maintenance Phase |
50.3; 56.4; 55.4 | — |
| SECONDARY Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 3 |
-0.5; -0.7; -0.7 | — |
| SECONDARY Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 4 |
-0.9; -1.4; -1.3 | — |
| SECONDARY Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 5 |
-1.3; -1.7; -1.8 | — |
| SECONDARY Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 6 |
-1.9; -2.1; -2.2 | — |
| SECONDARY Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 7 |
-2.2; -2.3; -2.5 | — |
| SECONDARY Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 8 |
-2.2; -2.5; -2.6 | — |
| SECONDARY Within-subject Change in Average Daily Pain Score From the Baseline Week to the Titration Phase |
-1.0; -1.3; -1.4 | — |
| SECONDARY Within-subject Change in Average Daily Pain Score From the Baseline Week to the Maintenance Phase |
-2.1; -2.3; -2.3 | — |
| SECONDARY Within-subject Change in Average Daily Pain Score From the Baseline Week to the Treatment Phase |
-1.6; -1.9; -2.0 | — |
| SECONDARY Within-subject Change in Average Daily Pain Score From the Baseline Week to the Last 4 Weeks of Maintenance Phase |
-1.9; -2.2; -2.4 | — |
| SECONDARY Within-subject Change From the Baseline Week to Visit 3 in Daily Perception of Pain Interference With Subject's Sleep |
-0.5; -0.7; -0.6 | — |
| SECONDARY Within-subject Change From the Baseline Week to Visit 4 in Daily Perception of Pain Interference With Subject's Sleep |
-0.9; -1.3; -1.3 | — |
| SECONDARY Within-subject Change From the Baseline Week to Visit 5 in Daily Perception of Pain Interference With Subject's Sleep |
-1.4; -1.7; -1.8 | — |
| SECONDARY Within-subject Change From the Baseline Week to Visit 6 in Daily Perception of Pain Interference With Subject's Sleep |
-1.9; -2.0; -2.2 | — |
| SECONDARY Within-subject Change From the Baseline Week to Visit 7 in Daily Perception of Pain Interference With Subject's Sleep |
-2.2; -2.3; -2.5 | — |
| SECONDARY Within-subject Change From the Baseline Week to Visit 8 in Daily Perception of Pain Interference With Subject's Sleep |
-2.1; -2.5; -2.5 | — |
| SECONDARY Within-subject Change From the Baseline Week to the Titration Phase in Daily Perception of Pain Interference With Subject's Sleep |
-1.0; -1.3; -1.3 | — |
| SECONDARY Within-subject Change From the Baseline Week to the Maintenance Phase in Daily Perception of Pain Interference With Subject's Sleep |
-2.0; -2.2; -2.4 | — |
| SECONDARY Within-subject Change From the Baseline Week to the Treatment Phase in Daily Perception of Pain Interference With Subject's Sleep |
-1.6; -1.8; -2.0 | — |
| SECONDARY Within-subject Change From the Baseline Week to the Last 4 Weeks of Maintenance Phase in Daily Perception of Pain Interference With Subject's Sleep |
-1.9; -2.1; -2.3 | — |
| SECONDARY Within-subject Change From the Baseline Week to Visit 3 in Daily Perception of Pain Interference With Subject's General Activity |
-0.6; -0.7; -0.7 | — |
| SECONDARY Within-subject Change From the Baseline Week to Visit 4 in Daily Perception of Pain Interference With Subject's General Activity |
-1.0; -1.3; -1.3 | — |
| SECONDARY Within-subject Change From the Baseline Week to Visit 5 in Daily Perception of Pain Interference With Subject's General Activity |
-1.4; -1.6; -1.8 | — |
| SECONDARY Within-subject Change From the Baseline Week to Visit 6 in Daily Perception of Pain Interference With Subject's General Activity |
-1.9; -2.0; -2.1 | — |
| SECONDARY Within-subject Change From the Baseline Week to Visit 7 in Daily Perception of Pain Interference With Subject's General Activity |
-2.2; -2.3; -2.3 | — |
| SECONDARY Within-subject Change From the Baseline Week to Visit 8 in Daily Perception of Pain Interference With Subject's General Activity |
-2.1; -2.4; -2.4 | — |
| SECONDARY Within-subject Change From the Baseline Week to the Titration Phase in Daily Perception of Pain Interference With Subject's General Activity |
-1.0; -1.2; -1.3 | — |
| SECONDARY Within-subject Change From the Baseline Week to the Maintenance Phase in Daily Perception of Pain Interference With Subject's General Activity |
-2.0; -2.2; -2.2 | — |
| SECONDARY Within-subject Change From the Baseline Week to the Treatment Phase in Daily Perception of Pain Interference With Subject's General Activity |
-1.6; -1.8; -1.9 | — |
| SECONDARY Within-subject Change From the Baseline Week to the Last 4 Weeks of the Maintenance Phase in Daily Perception of Pain Interference With Subject's General Activity |
-1.9; -2.1; -2.2 | — |
| SECONDARY Percentage of Days of Rescue Medication Use During the Treatment Phase |
6.6; 7.0; 9.1 | — |
| SECONDARY Within-subject Change From Baseline to Visit 8 in Subject's Quality of Life |
3.8; 4.4; 15.3; 10.3; 13.4; 16.9 | — |
| SECONDARY Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 8 |
1.2; 0.6; 1.2; 1.7; 3.5; 2.6 | — |
| SECONDARY Percentage of Patients With Categorized Satisfaction With Medications at Visit 8 |
11.7; 14.0; 15.5; 43.9; 45.5; 50.0 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores at Visit 8 |
-13.4; -15.2; -17.1; -7.0; -2.1; -4.6 | — |
Summary
The purpose of this trial is to assess whether 400mg/day of lacosamide is effective in reducing pain caused by distal diabetic neuropathy. Two dose-escalation schemes for lacosamide will be used to further determine the efficacy of the "standard" scheme and to evaluate the efficacy and safety of a more rapid titration scheme. Subjects will be randomly assigned to one of three treatment groups. Subjects in two of the groups will receive lacosamide at a dose of 400mg/day, but different dose-escalation schemes will be used to reach this final dose. The third group of subjects will receive a placebo. Subjects will have a 2 in 3 (66 %) chance of getting lacosamide.
The maximum lacosamide dose in this trial will be 400mg/day. The maximum treatment duration will be 18 weeks, including a two-week Pre-Treatment Phase and a 12 weeks period on a stable dose of lacosamide or placebo.
Eligibility Criteria
Inclusion Criteria
- Subject has had symptoms of painful diabetic neuropathy for at least 6 months and has a diagnosis of diabetes mellitus (Type I or Type II).
Exclusion Criteria
- Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial
Data sourced from ClinicalTrials.gov (NCT00350103). 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.