Status:
COMPLETED
An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain
Lead Sponsor:
UCB Pharma
Conditions:
Chronic Refractory Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00237458
Start Date
May 1 2001
End Date
March 1 2011
Last Update
August 28 2017
Active Locations (1)
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1
Monheim, Germany