An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain

Phase 2

Completed

Conditions: Chronic Refractory Neuropathic Pain

Interventions: Drug: Lacosamide

Registration Number: NCT00237458

Lead Sponsor: UCB Pharma

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 7

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lacosamide	Lacosamide	Open-label active treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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 - 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 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).
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
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
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).
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.