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This trial is the follow-on trial to a preceeding open-label trial which included patients with chronic refractory neuropathic pain. It is conducted at one site in the United Kingdom and the patient enrollment is completed. The patients had successfully completed the above mentioned trial and, in the investigator's opinion, would benefit from long-term administration of Lacosamide. After a 1-week run-in phase the patients were uptitrated to their optimal dose and then continued into the maintenance phase. Different pain qualities are assessed by a patient's diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Experimental | Open-label active treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period. | From Baseline Visit to Final Week of Treatment (approximately 10 years) | |
| Number of Subjects Withdrawing From Study Due To A Treatment-Emergent Adverse Event (TEAE) During The Treatment Period. | From Baseline Visit to Final Week of Treatment (approximately 10 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Within-Subject Change In Average Daily Pain Score During the Treatment Period. | The Average Daily Pain Score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced). | From Baseline Visit to Final Week of Treatment (approximately 9 years) |
| Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monheim | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14625037 | Result | McCleane G, Koch B, Rauschkolb C. Does SPM 927 have an analgesic effect in human neuropathic pain? An open label study. Neurosci Lett. 2003 Dec 4;352(2):117-20. doi: 10.1016/j.neulet.2003.08.036. | |
| 18619874 | Result | Shaibani A, Biton V, Rauck R, Koch B, Simpson J. Long-term oral lacosamide in painful diabetic neuropathy: a two-year open-label extension trial. Eur J Pain. 2009 May;13(5):458-63. doi: 10.1016/j.ejpain.2008.05.016. Epub 2008 Jul 10. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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One subject was discontinued on the study due to the Adverse Event of Vertigo. However, the Termination page of the Case Report Form reflected that the subject withdrew consent. Therefore, the Participant Flow will reflect 3 subjects did not complete the study, while the subjects withdrawing from Adverse Events will reflect 2.
The study started in May 2001 with subjects from Germany. The primary completion date and study completion date occurred in March 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lacosamide | Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain). |
| From Baseline Visit to Final Week of Treatment (approximately 9 years) |
| Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Burning. | Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain). | From Baseline Visit to Final Week of Treatment (approximately 9 years) |
| Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Paraesthesiae. | Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain). | From Baseline Visit to Final Week of Treatment (approximately 9 years) |
| Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness. | Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain). | From Baseline Visit to Final Week of Treatment (approximately 9 years) |
| Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Allodynia. | Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain). Allodynia is defined as neuropathic pain caused by normally innocuous stimuli becoming painful. | From Baseline Visit to Final Week of Treatment (approximately 9 years) |
| Subject's Global Impression of Change In Pain During The Treatment Period. | The Subject's Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:
| From Baseline Visit to Final Week of Treatment (approximately 9 years) |
| Investigator's Global Impression of Change In Pain During The Treatment Period. | The Investigator's Global Impression of Change is a physician's assessment of the patient's overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:
| From Baseline Visit to Final Week of Treatment (approximately 9 years) |
| Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Baseline Phase. | The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment). The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication. Summary statistics include mean and standard deviation. | Baseline Period (approximately 1 week) |
| Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration Phase. | The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment). The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication. Summary statistics include mean and standard deviation. | Titration Period (approximately 6 weeks) |
| Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration and Treatment Phases. | The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment). The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication. Summary statistics include mean and standard deviation. | From Titration Phase through Treatment Phase (approximately 9 years) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lacosamide | Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period. | Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis. | Posted | Number | participants | From Baseline Visit to Final Week of Treatment (approximately 10 years) |
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| Primary | Number of Subjects Withdrawing From Study Due To A Treatment-Emergent Adverse Event (TEAE) During The Treatment Period. | Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis. | Posted | Number | participants | From Baseline Visit to Final Week of Treatment (approximately 10 years) |
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| Secondary | Within-Subject Change In Average Daily Pain Score During the Treatment Period. | The Average Daily Pain Score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced). | Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | From Baseline Visit to Final Week of Treatment (approximately 9 years) |
|
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| Secondary | Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting. | Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain). | Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | From Baseline Visit to Final Week of Treatment (approximately 9 years) |
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| Secondary | Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Burning. | Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain). | Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | From Baseline Visit to Final Week of Treatment (approximately 9 years) |
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| Secondary | Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Paraesthesiae. | Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain). | Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | From Baseline Visit to Final Week of Treatment (approximately 9 years) |
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| Secondary | Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness. | Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain). | Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | From Baseline Visit to Final Week of Treatment (approximately 9 years) |
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| Secondary | Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Allodynia. | Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain). Allodynia is defined as neuropathic pain caused by normally innocuous stimuli becoming painful. | Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | From Baseline Visit to Final Week of Treatment (approximately 9 years) |
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| Secondary | Subject's Global Impression of Change In Pain During The Treatment Period. | The Subject's Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:
| Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis. | Posted | Number | percentage of participants | From Baseline Visit to Final Week of Treatment (approximately 9 years) |
|
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| Secondary | Investigator's Global Impression of Change In Pain During The Treatment Period. | The Investigator's Global Impression of Change is a physician's assessment of the patient's overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:
| Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis. | Posted | Number | percentage of participants | From Baseline Visit to Final Week of Treatment (approximately 9 years) |
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| Secondary | Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Baseline Phase. | The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment). The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication. Summary statistics include mean and standard deviation. | Of the 7 subjects in the Safety Set (SS), 4 are included in this analysis. | Posted | Mean | Standard Deviation | percentage of days | Baseline Period (approximately 1 week) |
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| Secondary | Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration Phase. | The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment). The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication. Summary statistics include mean and standard deviation. | Of the 7 subjects in the Safety Set (SS), 4 are included in this analysis. | Posted | Mean | Standard Deviation | percentage of days | Titration Period (approximately 6 weeks) |
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| Secondary | Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration and Treatment Phases. | The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment). The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication. Summary statistics include mean and standard deviation. | Of the 7 subjects in the Safety Set (SS), 5 are included in this analysis. | Posted | Mean | Standard Deviation | percentage of days | From Titration Phase through Treatment Phase (approximately 9 years) |
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The Time Frame for Adverse Event Reporting was the maximum exposure time of 9.5 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lacosamide | Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years | 4 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | MedDRA version 9.1 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA version 9.1 | Non-systematic Assessment |
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| Femur Fracture | Injury, poisoning and procedural complications | MedDRA version 9.1 | Non-systematic Assessment |
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| Weight Decreased | Investigations | MedDRA version 9.1 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Circulatory Collapse | Vascular disorders | MedDRA version 9.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus Bradycardia | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Sinus Tachycardia | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Conjunctival Haemorrhage | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Iritis | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Enterocolitis Haemorrhagic | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Peptic Ulcer | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Localised Infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Lower Respiratory Tract Infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Mumps | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Viral Infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Foot Fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| Fractured Coccyx | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| Joint Sprain | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| Muscle Strain | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Basophil Count Increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Blood Phosphorus Increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Blood Sodium Decreased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Electrocardiogram QT Corrected Interval Prolonged | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Electrocardiogram QT Prolonged | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Gamma-glutamyltransferase Increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Neutrophil Count Decreased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Platelet Count Decreased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Thyroxine Free Increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Diabetes Mellitus Non-insulin-dependent | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Tension Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
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UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB (Study Director) | UCB Clinical Trial Call Center | +1 887 822 9493 |
| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| C476828 | 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)- |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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