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 Pharma7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Refractory Neuropathic Pain

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

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 Outcomes

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).