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

UCB

Status and phase

Completed

Phase 2

Conditions

Chronic Refractory Neuropathic Pain

Treatments

Drug: Lacosamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00237458

SP0647

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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