Back to resultsAn Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain
Primary Purpose
Chronic Refractory Neuropathic Pain
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Lacosamide
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Refractory Neuropathic Pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lacosamide
Arm Description
Open-label active treatment
Outcomes
Primary Outcome Measures
Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.
Number of Subjects Withdrawing From Study Due To A Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.
Secondary Outcome Measures
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).
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).
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).
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).
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).
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.
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:
Much better
Moderately better
Mildly better
No change
Mildly worse
Moderately worse
Much worse
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:
Much better
Moderately better
Mildly better
No change
Mildly worse
Moderately worse
Much worse
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00237458
Brief Title
An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain
Official Title
An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Refractory Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
Open-label active treatment
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
SPM 927, Vimpat
Intervention Description
Dosage: Lacosamide up to 400 mg/day;
Dosage form: Film-coated tablets;
Dosage Frequency and Duration: Two times per day; 9.5 years
Primary Outcome Measure Information:
Title
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)
Title
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)
Secondary Outcome Measure Information:
Title
Within-Subject Change In Average Daily Pain Score During the Treatment Period.
Description
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)
Title
Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting.
Description
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)
Title
Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Burning.
Description
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)
Title
Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Paraesthesiae.
Description
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)
Title
Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness.
Description
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)
Title
Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Allodynia.
Description
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)
Title
Subject's Global Impression of Change In Pain During The Treatment Period.
Description
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:
Much better
Moderately better
Mildly better
No change
Mildly worse
Moderately worse
Much worse
Time Frame
From Baseline Visit to Final Week of Treatment (approximately 9 years)
Title
Investigator's Global Impression of Change In Pain During The Treatment Period.
Description
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:
Much better
Moderately better
Mildly better
No change
Mildly worse
Moderately worse
Much worse
Time Frame
From Baseline Visit to Final Week of Treatment (approximately 9 years)
Title
Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Baseline Phase.
Description
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)
Title
Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration Phase.
Description
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)
Title
Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration and Treatment Phases.
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Monheim
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
14625037
Citation
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.
Results Reference
result
PubMed Identifier
18619874
Citation
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.
Results Reference
result
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain
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