Trial · NCT00220337
A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
NCT00220337, Phase 3, Completed, UCB Pharma; results first posted 2023-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy. Trials, record NCT00220337. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00220337
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
- NCT number
- NCT00220337
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 371 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Painful Diabetic Neuropathy
- Interventions
- Lacosamide
- First posted
- 2005-09-22
- Last updated
- 2023-07-24
- Other registries' IDs
- eudract:2004-000960-28
- Results first posted
- 2023-07-24
Source ClinicalTrials.gov
Registered outcomes113
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Adverse Events (AE) Reported Spontaneously by the Subject or Observed by the Investigator | From Screening until Safety Follow up Visit (up to 140 weeks) | An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. |
| Primary | Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period | During the titration period (up to Week 8) | Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (\<=.85x Lower Limit Normal \[LLN\] or \>= 1.15x Upper Limit Normal \[ULN\] - Hemoglobin (\<=.85x LLN or \>=1.15x ULN) - White Blood Cell (WBC) Count (\<=3.0 or \>=16.0 G/l) - Basophils (\>=5.0%) - Eosinophils (\>=10%) - Monocytes (\>=20%) - Platelet Count (\<=100 or \>=600 G/l) |
| Primary | Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period | During the maintenance period (up to 136 weeks) | Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (\<=.85x Lower Limit Normal \[LLN\] or \>= 1.15x Upper Limit Normal \[ULN\] - Hemoglobin (\<=.85x LLN or \>=1.15x ULN) - White Blood Cell (WBC) Count (\<=3.0 or \>=16.0 G/l) - Basophils (\>=5.0%) - Eosinophils (\>=10%) - Monocytes (\>=20%) - Platelet Count (\<=100 or \>=600 G/l) |
| Primary | Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period | During the titration period (up to Week 8) | Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase (\[ALT\] 3x ULN) - Alanine aminotransferase (\[ALT\] 5x ULN) - Alanine aminotransferase \[(ALT\] 10x ULN) - Aspartate aminotransferase (\[AST\] 3x ULN) - Aspartate aminotransferase (\[AST\] 5x ULN) - Aspartate aminotransferase (\[AST\] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase (\[GGT\] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (\<26 g/l) - Blood Urea Nitrogen (\>=14.28 mmol/l) - Creatinine (\>=2.0 mg/dl) - Calcium (\<=7.6 or \>=11.0 mg/dl) - Chloride (\<=90 or \>=112 mmol/l) - Phosphorus (\<=2.0 or \>=6.0 mg/dl) - Potassium (\<=3.0 or \>=6.0 mmol/l) - Sodium (\<127 or \>151 mmol/l) - Glucose (\<50 or \>=200 mg/dl) - Total Cholesterol (\>6.5 mmol/l) - Uric Acid (\>565.06 umol/l) |
| Primary | Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period | During the maintenance period (up to 136 weeks) | Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase (\[ALT\] 3x ULN) - Alanine aminotransferase (\[ALT\] 5x ULN) - Alanine aminotransferase \[(ALT\] 10x ULN) - Aspartate aminotransferase (\[AST\] 3x ULN) - Aspartate aminotransferase (\[AST\] 5x ULN) - Aspartate aminotransferase (\[AST\] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase (\[GGT\] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (\<26 g/l) - Blood Urea Nitrogen (\>=14.28 mmol/l) - Creatinine (\>=2.0 mg/dl) - Calcium (\<=7.6 or \>=11.0 mg/dl) - Chloride (\<=90 or \>=112 mmol/l) - Phosphorus (\<=2.0 or \>=6.0 mg/dl) - Potassium (\<=3.0 or \>=6.0 mmol/l) - Sodium (\<127 or \>151 mmol/l) - Glucose (\<50 or \>=200 mg/dl) - Total Cholesterol (\>6.5 mmol/l) - Uric Acid (\>565.06 umol/l) |
| Primary | Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit | Baseline, Last Visit (up to 140 weeks) | Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits. |
| Primary | Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit | Baseline, Last Visit (up to 140 weeks) | Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits. |
| Primary | Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit | Baseline, Last Visit (up to 140 weeks) | Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits. |
| Primary | Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit | Baseline, Last Visit (up to 140 weeks) | Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits. |
| Primary | Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit | Baseline, Last Visit (up to 140 weeks) | Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits. |
1 to 10 of 113Source ClinicalTrials.gov
See all 113 registered outcomesOutcomes113
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With Adverse Events (AE) Reported Spontaneously by the Subject or Observed by the Investigator | From Screening until Safety Follow up Visit (up to 140 weeks) | The Safety Set (SS) was defined as all subjects who signed the informed consent form and took at least 1 dose of trial medication. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period | During the titration period (up to Week 8) | Safety Set included 371 subjects. Only subjects with valid data for hematology parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different hematologic parameters. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period | During the maintenance period (up to 136 weeks) | Safety Set included 371 subjects. Only subjects with valid data for hematology parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different hematologic parameters. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period | During the titration period (up to Week 8) | Safety Set included 371 subjects. Only subjects with valid data for clinical chemistry parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different clinical chemistry parameters. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period | During the maintenance period (up to 136 weeks) | Safety Set included 371 subjects. Only subjects with valid data for clinical chemistry parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different clinical chemistry parameters. | percentage of participants | NUMBER |
| PRIMARY | Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit | Baseline, Last Visit (up to 140 weeks) | Only subjects with urine pH= 5.0 at baseline are included in this analysis. | Participants | NUMBER |
| PRIMARY | Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit | Baseline, Last Visit (up to 140 weeks) | Only subjects with urine pH= 6.0 at baseline are included in this analysis. | Participants | NUMBER |
| PRIMARY | Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit | Baseline, Last Visit (up to 140 weeks) | Only subjects with urine pH= 6.5 at baseline are included in this analysis. | Participants | NUMBER |
| PRIMARY | Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit | Baseline, Last Visit (up to 140 weeks) | Only subjects with urine pH= 7.0 at baseline are included in this analysis. | Participants | NUMBER |
| PRIMARY | Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit | Baseline, Last Visit (up to 140 weeks) | Only subjects with urine pH= 7.5 at baseline are included in this analysis. | Participants | NUMBER |
1 to 10 of 113Source ClinicalTrials.gov
See all 113 outcomesResults by group848
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Adverse Events (AE) Reported Spontaneously by the Subject or Observed by the Investigator | Lacosamide | 80.9 | percentage of participants | ||
| Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period | Lacosamide | Hematocrit | 0.8 | percentage of participants | |
| Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period | Lacosamide | Hemoglobin | 0.5 | percentage of participants | |
| Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period | Lacosamide | White Blood Cell | 1.4 | percentage of participants | |
| Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period | Lacosamide | Basophils | 1.1 | percentage of participants | |
| Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period | Lacosamide | Eosinophils | 0 | percentage of participants | |
| Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period | Lacosamide | Monocytes | 0 | percentage of participants | |
| Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period | Lacosamide | Platelet Count | 1.1 | percentage of participants | |
| Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period | Lacosamide | Hematocrit | 6.2 | percentage of participants | |
| Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period | Lacosamide | Hemoglobin | 5.5 | percentage of participants |
1 to 10 of 848Source ClinicalTrials.gov
See all 848 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lacosamide | 371 | |
| Overall Study | COMPLETED | Lacosamide | 192 | |
| Overall Study | NOT COMPLETED | Lacosamide | 179 |
Source ClinicalTrials.gov
Adverse events112
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 | Nasopharyngitis | Infections and infestations | Lacosamide | 43 | 371 | |
| other | Influenza | Infections and infestations | Lacosamide | 21 | 371 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Lacosamide | 26 | 371 | |
| other | Dizziness | Nervous system disorders | Lacosamide | 75 | 371 | |
| other | Headache | Nervous system disorders | Lacosamide | 44 | 371 | |
| other | Somnolence | Nervous system disorders | Lacosamide | 34 | 371 | |
| other | Tremor | Nervous system disorders | Lacosamide | 24 | 371 | |
| other | Hypertension | Vascular disorders | Lacosamide | 26 | 371 | |
| other | Vertigo | Ear and labyrinth disorders | Lacosamide | 45 | 371 | |
| other | Nausea | Gastrointestinal disorders | Lacosamide | 49 | 371 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lacosamide | 7 | 371 |
| Total, other adverse events | Lacosamide | 229 | 371 |
| Total, serious adverse events | Lacosamide | 83 | 371 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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