Status:
COMPLETED
A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
Lead Sponsor:
UCB Pharma
Conditions:
Diabetic Neuropathy
Eligibility:
All Genders
32-81 years
Phase:
PHASE2
PHASE3
Brief Summary
Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the diffe...
Detailed Description
This phase 2/3 open-label trial is being conducted at approximately 100 sites in the US to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful ...
Eligibility Criteria
Inclusion
- Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion, might benefit from long-term administration of SPM 927. Exception: subjects who prematurely discontinued Study SP742 or SP768 due to lack of efficacy or due to intolerability to trial medication may be eligible to participate in Study SP745, after consultation with the medical monitor.
Exclusion
- Subject has clinically relevant electrocardiogram (ECG) abnormalities, or QT-corrected (QTc) interval \>=500 milliseconds (ms), and/or a QTc interval increase of \>=60ms from the mean pre-dose QTc value at Visit 2 of Studies SP665, SP742 or SP768.
- Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>=3 times the upper limit of the normal range (ULN) with total bilirubin \>=2 times ULN or transaminases (AST and/or ALT) \>=5 times ULN.
- Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
451 Patients enrolled
Trial Details
Trial ID
NCT00235443
Start Date
September 1 2004
End Date
July 1 2008
Last Update
July 17 2018
Active Locations (84)
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1
Anniston, Alabama, United States
2
Hoover, Alabama, United States
3
Huntsville, Alabama, United States
4
Northport, Alabama, United States