Chronic Refractory Neuropathic Pain
Conditions
Brief summary
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.
Interventions
DRUGLacosamide
Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is informed and given ample time and opportunity to think about her/his participation in this extension trial and has given her/his written informed consent * Subject met all inclusion criteria defined in the SP611 trial with SPM927 at the time of enrollment into trial SP611 * Subject has successfully completed trial SP611 and, in the investigator's opinion, would benefit from long-term administration of SPM927 * Subject is willing and able to comply with all trial requirements, including the ability to complete trial questionnaires
Exclusion criteria
* Subject previously participated in this trial * Subject has participated in another trial of an investigational drug within the last 3 months (excluding trial SP611) or is currently participating in another trial of an investigational drug * Subject has had prior therapy with a Nonsteroidal Anti-inflammatory Drug (NSAID) or Anti-epileptic Drug (AED) within 28 days prior to the Eligibility Visit * Subject has evidence or history of significant Cardiovascular Disease within 12 months prior to the Eligibility Visit * Subject has laboratory values, which are outside the normal range and judged by the Investigator to be clinically significant * Subject has abnormal Renal or Hepatic function * Subject has a history of Malignancies with the exception of subjects with a documented disease-free interval of 5 years or more * Subject has a history of chronic alcohol or drug abuse within the last 12 months * Subject has any medical or psychiatric condition which, in the opinion of the Investigator, could jeopardize or compromise the subject's ability to participate in this continuation trial * Subject with a known history of severe Anaphylactic Reaction and/or serious or life threatening Blood Dyscrasias
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Burning. | From Baseline Visit to Final Week of Treatment (approximately 9 years) | Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain). |
| Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Paraesthesiae. | From Baseline Visit to Final Week of Treatment (approximately 9 years) | Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain). |
| Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness. | From Baseline Visit to Final Week of Treatment (approximately 9 years) | Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain). |
| Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Allodynia. | From Baseline Visit to Final Week of Treatment (approximately 9 years) | 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. |
| Within-Subject Change In Average Daily Pain Score During the Treatment Period. | From Baseline Visit to Final Week of Treatment (approximately 9 years) | The Average Daily Pain Score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced). |
| Investigator's Global Impression of Change In Pain During The Treatment Period. | From Baseline Visit to Final Week of Treatment (approximately 9 years) | 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: 1. Much better 2. Moderately better 3. Mildly better 4. No change 5. Mildly worse 6. Moderately worse 7. Much worse |
| Percentage of Days With Concomitant Pain (Rescue) Medications Taken During Baseline Phase. | Baseline Period (approximately 1 week) | 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. |
| Percentage of Days With Concomitant Pain (Rescue) Medications Taken During Titration Phase. | Titration Period (approximately 6 weeks) | 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. |
| Percentage of Days With Concomitant Pain (Rescue) Medications Taken During Titration and Treatment Phases. | From Titration Phase through Treatment Phase (approximately 9 years) | 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. |
| Subject's Global Impression of Change In Pain During The Treatment Period. | From Baseline Visit to Final Week of Treatment (approximately 9 years) | 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: 1. Much better 2. Moderately better 3. Mildly better 4. No change 5. Mildly worse 6. Moderately worse 7. Much worse |
| Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting. | From Baseline Visit to Final Week of Treatment (approximately 9 years) | Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain). |
Countries
Germany
Participant flow
Recruitment details
The study started in May 2001 with subjects from Germany. The primary completion date and study completion date occurred in March 2011.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Lacosamide Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Lacosamide |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 47.4 years STANDARD_DEVIATION 10.18 |
| Region of Enrollment Germany | 7 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 7 |
| serious Total, serious adverse events | 4 / 7 |
Outcome results
Primary
Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.
Time frame: From Baseline Visit to Final Week of Treatment (approximately 10 years)
Population: Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period. | 7 participants |
Primary
Number of Subjects Withdrawing From Study Due To A Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.
Time frame: From Baseline Visit to Final Week of Treatment (approximately 10 years)
Population: Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Number of Subjects Withdrawing From Study Due To A Treatment-Emergent Adverse Event (TEAE) During The Treatment Period. | 2 participants |
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: 1. Much better 2. Moderately better 3. Mildly better 4. No change 5. Mildly worse 6. Moderately worse 7. Much worse
Time frame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
Population: Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lacosamide | Investigator's Global Impression of Change In Pain During The Treatment Period. | Better | 85.7 percentage of participants |
| Lacosamide | Investigator's Global Impression of Change In Pain During The Treatment Period. | No Change | 14.3 percentage of participants |
| Lacosamide | Investigator's Global Impression of Change In Pain During The Treatment Period. | Worse | 0 percentage of participants |
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.
Time frame: Baseline Period (approximately 1 week)
Population: Of the 7 subjects in the Safety Set (SS), 4 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lacosamide | Percentage of Days With Concomitant Pain (Rescue) Medications Taken During Baseline Phase. | 100 percentage of days | Standard Deviation 0 |
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.
Time frame: From Titration Phase through Treatment Phase (approximately 9 years)
Population: Of the 7 subjects in the Safety Set (SS), 5 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lacosamide | Percentage of Days With Concomitant Pain (Rescue) Medications Taken During Titration and Treatment Phases. | 12.3 percentage of days | Standard Deviation 7.91 |
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.
Time frame: Titration Period (approximately 6 weeks)
Population: Of the 7 subjects in the Safety Set (SS), 4 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lacosamide | Percentage of Days With Concomitant Pain (Rescue) Medications Taken During Titration Phase. | 51.3 percentage of days | Standard Deviation 36.98 |
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: 1. Much better 2. Moderately better 3. Mildly better 4. No change 5. Mildly worse 6. Moderately worse 7. Much worse
Time frame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
Population: Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lacosamide | Subject's Global Impression of Change In Pain During The Treatment Period. | Better | 85.7 percentage of participants |
| Lacosamide | Subject's Global Impression of Change In Pain During The Treatment Period. | No Change | 14.3 percentage of participants |
| Lacosamide | Subject's Global Impression of Change In Pain During The Treatment Period. | Worse | 0 percentage of participants |
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).
Time frame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
Population: Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lacosamide | Within-Subject Change In Average Daily Pain Score During the Treatment Period. | -2.9 units on a scale | Standard Deviation 3.38 |
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.
Time frame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
Population: Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lacosamide | Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Allodynia. | 0.6 units on a scale | Standard Deviation 2.37 |
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).
Time frame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
Population: Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lacosamide | Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Burning. | 0.4 units on a scale | Standard Deviation 2.15 |
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).
Time frame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
Population: Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lacosamide | Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness. | -2.4 units on a scale | Standard Deviation 3.78 |
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).
Time frame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
Population: Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lacosamide | Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Paraesthesiae. | -2.1 units on a scale | Standard Deviation 3.34 |
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).
Time frame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
Population: Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lacosamide | Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting. | -2.3 units on a scale | Standard Deviation 4.27 |