A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy

Completed · Phase 2/Phase 3

Conditions studied: Diabetic Neuropathy

In brief

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 different doses of lacosamide will be investigated.

Key facts

Study ID

NCT00235443

Run by

UCB Pharma

People needed

451

Starts

2004-09-01

Expected to finish

2008-07-01

Last updated by the study team

2018-07-17

Who can join

Age: 32 and older, up to 81. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Hoover, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Northport, Alabama, United States
• Study site — Tuscaloosa, Alabama, United States
• Study site — Peoria, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Irvine, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Monica, California, United States
• Study site — Spring Valley, California, United States
• Study site — Tustin, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Denver, Colorado, United States
• Study site — Stratford, Connecticut, United States
• Study site — Newark, Delaware, United States
• Study site — Wilmington, Delaware, United States
• Study site — Bradenton, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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