An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain
Condition: Chronic Refractory Neuropathic Pain
MeSH terms: Neuralgia
Intervention: Lacosamide
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
Intervention MeSH terms: Lacosamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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