Trial · NCT00235443
A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
NCT00235443, Phase 2, Phase 3, Completed, UCB Pharma; results first posted 2009-10-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy. Trials, record NCT00235443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00235443
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
- NCT number
- NCT00235443
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 451 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Diabetic Neuropathy
- Interventions
- lacosamide
- First posted
- 2005-10-10
- Last updated
- 2018-07-17
- Results first posted
- 2009-10-05
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator. | Throughout the study up to a maximum study period of 2.8 years | Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious). |
| Secondary | Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10). | Baseline to end of entire treatment phase (maximum study period of 2.8 years). | Change from Baseline in average daily pain score using an 11-point Likert scale (0-10). On Likert scale, 0=no pain and 10=worst possible pain. |
| Secondary | Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS). | Baseline to end of entire treatment phase (maximum study period of 2.8 years). | Change from Baseline in average pain score as measured by a 100mm Visual Analogue Scale (VAS). On VAS 0mm=no pain and 100mm=worst possible pain. |
| Secondary | Patient's Global Impression of Change (PGIC) From Baseline in Pain. | Baseline to Termination Visit | Patient's Global Impression of Change (PGIC) from Baseline in Pain. Original categorical responses are much worse, moderately worse, mildly worst, no change, mildly better, moderately better, and much better. Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse). |
| Secondary | Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity. | Baseline to Termination Visit | Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for intensity of pain where 0=no pain and 10=most intense pain sensation imaginable. |
| Secondary | Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness | Baseline to Termination Visit | Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for sharpness of pain where 0=not sharp and 10=most sharp sensation imaginable ("like a knife"). |
| Secondary | Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat | Baseline to Termination Visit | Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with heat sensation where 0=not hot and 10=the most hot sensation imaginable ("on fire"). |
| Secondary | Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness | Baseline to Termination Visit | Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with dullness of pain where 0=not dull and 10=most dull sensation imaginable. |
| Secondary | Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold | Baseline to Termination Visit | Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with cold sensation where 0=not cold and 10=most cold sensation imaginable ("freezing"). |
| Secondary | Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity | Baseline to Termination Visit | Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with sensitivity of pain where 0=not sensitive and 10=most sensitive sensation imaginable ("raw skin"). |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator. | Throughout the study up to a maximum study period of 2.8 years | Safety population are subjects who took at least one dose of lacosamide (LCM). | Participants | NUMBER |
| SECONDARY | Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10). | Baseline to end of entire treatment phase (maximum study period of 2.8 years). | Safety population are subjects who took at least one dose of lacosamide (LCM). | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS). | Baseline to end of entire treatment phase (maximum study period of 2.8 years). | Safety population are subjects who took at least one dose of lacosamide (LCM). | Units on a scale | MEAN |
| SECONDARY | Patient's Global Impression of Change (PGIC) From Baseline in Pain. | Baseline to Termination Visit | Safety population are subjects who took at least one dose of lacosamide (LCM). | Participants | NUMBER |
| SECONDARY | Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity. | Baseline to Termination Visit | Safety population are subjects who took at least one dose of lacosamide (LCM). | Units on a scale | MEAN |
| SECONDARY | Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness | Baseline to Termination Visit | Safety population are subjects who took at least one dose of lacosamide (LCM). | Units on a scale | MEAN |
| SECONDARY | Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat | Baseline to Termination Visit | Safety population are subjects who took at least one dose of lacosamide (LCM). | Units on a scale | MEAN |
| SECONDARY | Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness | Baseline to Termination Visit | Safety population are subjects who took at least one dose of lacosamide (LCM). | Units on a scale | MEAN |
| SECONDARY | Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold | Baseline to Termination Visit | Safety population are subjects who took at least one dose of lacosamide (LCM). | Units on a scale | MEAN |
| SECONDARY | Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity | Baseline to Termination Visit | Safety population are subjects who took at least one dose of lacosamide (LCM). | Units on a scale | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group140
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator. | Lacosamide 100mg/Day | 11 | Participants | ||
| Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator. | Lacosamide 200mg/Day | 52 | Participants | ||
| Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator. | Lacosamide 300mg/Day | 74 | Participants | ||
| Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator. | Lacosamide 400mg/Day | 196 | Participants | ||
| Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator. | Lacosamide 500mg/Day | 33 | Participants | ||
| Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator. | Lacosamide 600mg/Day | 50 | Participants | ||
| Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator. | Total | 416 | Participants | ||
| Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10). | Lacosamide 100mg/Day | -5.15 | Standard Deviation 2.345 | Units on a scale | |
| Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10). | Lacosamide 200mg/Day | -4.30 | Standard Deviation 1.991 | Units on a scale | |
| Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10). | Lacosamide 300mg/Day | -3.70 | Standard Deviation 2.020 | Units on a scale |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lacosamide 100mg/Day | 11 | |
| Overall Study | STARTED | Lacosamide 200mg/Day | 57 | |
| Overall Study | STARTED | Lacosamide 300mg/Day | 85 | |
| Overall Study | STARTED | Lacosamide 400mg/Day | 205 | |
| Overall Study | STARTED | Lacosamide 500mg/Day | 39 | |
| Overall Study | STARTED | Lacosamide 600mg/Day | 54 | |
| Overall Study | COMPLETED | Lacosamide 100mg/Day | 3 | |
| Overall Study | COMPLETED | Lacosamide 200mg/Day | 19 | |
| Overall Study | COMPLETED | Lacosamide 300mg/Day | 23 | |
| Overall Study | COMPLETED | Lacosamide 400mg/Day | 108 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,288
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 | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Lacosamide 100mg/Day | 1 | 11 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Lacosamide 200mg/Day | 1 | 57 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Lacosamide 300mg/Day | 4 | 85 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Lacosamide 400mg/Day | 10 | 205 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | Lacosamide 500mg/Day | 1 | 39 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Lacosamide 600mg/Day | 1 | 54 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Total | 18 | 451 | 18 |
| other | Atrial fibrillation | Cardiac disorders | Lacosamide 100mg/Day | 0 | 11 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Lacosamide 200mg/Day | 3 | 57 | 3 |
| other | Atrial fibrillation | Cardiac disorders | Lacosamide 300mg/Day | 1 | 85 | 1 |
1 to 10 of 1,288Source ClinicalTrials.gov
See all 1,288 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lacosamide 100mg/Day | ||
| Total, all-cause mortality | Lacosamide 200mg/Day | ||
| Total, all-cause mortality | Lacosamide 300mg/Day | ||
| Total, all-cause mortality | Lacosamide 400mg/Day | ||
| Total, all-cause mortality | Lacosamide 500mg/Day | ||
| Total, all-cause mortality | Lacosamide 600mg/Day | ||
| Total, all-cause mortality | Total | ||
| Total, other adverse events | Lacosamide 100mg/Day | 10 | 11 |
| Total, other adverse events | Lacosamide 200mg/Day | 47 | 57 |
| Total, other adverse events | Lacosamide 300mg/Day | 68 | 85 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 18619874 | DERIVED |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT00235443
GET https://conductscience.org/api/trials/v1/NCT00235443/results?page=2