Trial · NCT00350103

A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy

NCT00350103, Phase 3, Completed, UCB Pharma; results first posted 2024-03-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy. Trials, record NCT00350103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00350103

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy
NCT number: NCT00350103
Status: Completed
Phases: Phase 3
Enrollment: 551 participants, actual
Lead sponsor: UCB Pharma
Conditions: Painful Diabetic Neuropathy
Interventions: SPM 929, Placebo
First posted: 2006-07-10
Last updated: 2024-03-22
Other registries' IDs: eudract:2005-005788-27
Results first posted: 2024-03-22

Source ClinicalTrials.gov

Registered outcomes38

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Average Daily Pain Score From Baseline Week to the Last 4 Weeks of the Maintenance Phase	Last 4 weeks of Maintenance Phase, compared to the Baseline Week	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week.
Secondary	Time to Sustainable Pain Relief	From start of trial medication intake (Week 0) up to the last 4 weeks of the Maintenance Phase	Time to sustainable pain relief was defined as the time from Baseline to the first day on which there was a ≥1-point improvement over Baseline in the Likert pain score for those subjects for whom there was also ≥30% reduction in average daily pain score over the last 28 days of the Maintenance Phase as compared to Baseline.
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	Baseline week, last 4 weeks of the Maintenance Phase	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening.
Secondary	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 3	Baseline week, Visit 3	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.
Secondary	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 4	Baseline week, Visit 4	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.
Secondary	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 5	Baseline week, Visit 5	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.
Secondary	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 6	Baseline week, Visit 6	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.
Secondary	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 7	Baseline week, Visit 7	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.
Secondary	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 8	Baseline week, Visit 8	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.
Secondary	Within-subject Change in Average Daily Pain Score From the Baseline Week to the Titration Phase	Titration Phase (4 weeks), compared to the Baseline Week	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the titration phase and the average of the Baseline Week.

1 to 10 of 38Source ClinicalTrials.gov

See all 38 registered outcomes

Outcomes38

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Average Daily Pain Score From Baseline Week to the Last 4 Weeks of the Maintenance Phase	Last 4 weeks of Maintenance Phase, compared to the Baseline Week	Only subjects with available data for subject's average daily pain scores are included in the analysis.	units on a scale	MEAN
SECONDARY	Time to Sustainable Pain Relief	From start of trial medication intake (Week 0) up to the last 4 weeks of the Maintenance Phase	Only subjects with available data for subject's average daily pain scores are included in the analysis.	days	MEDIAN
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	Baseline week, last 4 weeks of the Maintenance Phase	Only subjects with available data for subject's average daily pain scores are included in the analysis.	percentage of participants	NUMBER
SECONDARY	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 3	Baseline week, Visit 3	Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.	units on a scale	MEAN
SECONDARY	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 4	Baseline week, Visit 4	Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.	units on a scale	MEAN
SECONDARY	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 5	Baseline week, Visit 5	Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.	units on a scale	MEAN
SECONDARY	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 6	Baseline week, Visit 6	Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.	units on a scale	MEAN
SECONDARY	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 7	Baseline week, Visit 7	Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.	units on a scale	MEAN
SECONDARY	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 8	Baseline week, Visit 8	Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.	units on a scale	MEAN
SECONDARY	Within-subject Change in Average Daily Pain Score From the Baseline Week to the Titration Phase	Titration Phase (4 weeks), compared to the Baseline Week	Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.	units on a scale	MEAN

1 to 10 of 38Source ClinicalTrials.gov

See all 38 outcomes

Results by group178

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Average Daily Pain Score From Baseline Week to the Last 4 Weeks of the Maintenance Phase	Placebo	-1.9	Standard Deviation 2.20	units on a scale
Change in Average Daily Pain Score From Baseline Week to the Last 4 Weeks of the Maintenance Phase	Lacosamide FT	-2.2	Standard Deviation 2.05	units on a scale
Change in Average Daily Pain Score From Baseline Week to the Last 4 Weeks of the Maintenance Phase	Lacosamide ST	-2.4	Standard Deviation 2.08	units on a scale
Time to Sustainable Pain Relief	Placebo	31.0	95% Confidence Interval 11.0 to NA	days
Time to Sustainable Pain Relief	Lacosamide FT	11.0	95% Confidence Interval 7.0 to 35.0	days
Time to Sustainable Pain Relief	Lacosamide ST	10.0	95% Confidence Interval 6.0 to NA	days
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	Placebo	50.3		percentage of participants
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	Lacosamide FT	56.4		percentage of participants
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	Lacosamide ST	55.4		percentage of participants
Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 3	Placebo	-0.5	Standard Deviation 1.13	units on a scale

1 to 10 of 178Source ClinicalTrials.gov

See all 178 results by group

Participant flow21

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	179
Overall Study	STARTED	Lacosamide Fast Titration (FT)	190
Overall Study	STARTED	Lacosamide Standard Titration (ST)	182
Overall Study	Entered Titration Phase	Placebo	179
Overall Study	Entered Titration Phase	Lacosamide Fast Titration (FT)	189
Overall Study	Entered Titration Phase	Lacosamide Standard Titration (ST)	181
Overall Study	Completed Titration Phase	Placebo	162
Overall Study	Completed Titration Phase	Lacosamide Fast Titration (FT)	164
Overall Study	Completed Titration Phase	Lacosamide Standard Titration (ST)	165
Overall Study	Entered Maintenance Phase	Placebo	162

1 to 10 of 21Source ClinicalTrials.gov

See all 21 participant flow

Adverse events90

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Vertigo	Ear and labyrinth disorders	Placebo	2	179
other	Vertigo	Ear and labyrinth disorders	Lacosamide Pooled FT and ST	21	370
other	Nausea	Gastrointestinal disorders	Placebo	4	179
other	Nausea	Gastrointestinal disorders	Lacosamide Pooled FT and ST	28	370
other	Nasopharyngitis	Infections and infestations	Placebo	11	179
other	Nasopharyngitis	Infections and infestations	Lacosamide Pooled FT and ST	20	370
other	Dizziness	Nervous system disorders	Placebo	3	179
other	Dizziness	Nervous system disorders	Lacosamide Pooled FT and ST	29	370
other	Headache	Nervous system disorders	Placebo	6	179
other	Headache	Nervous system disorders	Lacosamide Pooled FT and ST	23	370

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	179
Total, all-cause mortality	Lacosamide Pooled FT and ST	0	370
Total, other adverse events	Placebo	21	179
Total, other adverse events	Lacosamide Pooled FT and ST	82	370
Total, serious adverse events	Placebo	14	179
Total, serious adverse events	Lacosamide Pooled FT and ST	28	370

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29588972	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Lacosamide Pooled FT and ST vs Placebo: deaths from any cause	Trial comparisons
Lacosamide Pooled FT and ST vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00350103

GET https://conductscience.org/api/trials/v1/NCT00350103/registered?page=2

API reference For AI assistants