A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
NCT ID: NCT00235443
Last Updated: 2018-07-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
451 participants
INTERVENTIONAL
2004-09-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
lacosamide
Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period.
Interventions
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lacosamide
Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
32 Years
81 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Anniston, Alabama, United States
Hoover, Alabama, United States
Huntsville, Alabama, United States
Northport, Alabama, United States
Tuscaloosa, Alabama, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Irvine, California, United States
Los Angeles, California, United States
San Diego, California, United States
Santa Monica, California, United States
Spring Valley, California, United States
Tustin, California, United States
Walnut Creek, California, United States
Denver, Colorado, United States
Stratford, Connecticut, United States
Newark, Delaware, United States
Wilmington, Delaware, United States
Bradenton, Florida, United States
Clearwater, Florida, United States
Fort Myers, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
Pembroke Pines, Florida, United States
Pinellas Park, Florida, United States
South Miami, Florida, United States
St. Petersburg, Florida, United States
Sunrise, Florida, United States
Tallahassee, Florida, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Elk Grove Village, Illinois, United States
North Chicago, Illinois, United States
Evansville, Indiana, United States
West Des Moines, Iowa, United States
Crestview Hills, Kentucky, United States
Louisville, Kentucky, United States
Madisonville, Kentucky, United States
Paducah, Kentucky, United States
Owings Mills, Maryland, United States
Towson, Maryland, United States
Brockton, Massachusetts, United States
Ann Arbor, Michigan, United States
St Louis, Missouri, United States
Great Falls, Montana, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Lawrenceville, New Jersey, United States
Voorhees Township, New Jersey, United States
Albany, New York, United States
Mineola, New York, United States
White Plains, New York, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
Greenville, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Portland, Oregon, United States
Upland, Pennsylvania, United States
Greer, South Carolina, United States
Bristol, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Richardson, Texas, United States
San Antonio, Texas, United States
Bennington, Vermont, United States
Richmond, Virginia, United States
Salem, Virginia, United States
Virginia Beach, Virginia, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Wenatchee, Washington, United States
Countries
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References
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Shaibani A, Biton V, Rauck R, Koch B, Simpson J. Long-term oral lacosamide in painful diabetic neuropathy: a two-year open-label extension trial. Eur J Pain. 2009 May;13(5):458-63. doi: 10.1016/j.ejpain.2008.05.016. Epub 2008 Jul 10.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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SP0745
Identifier Type: -
Identifier Source: org_study_id
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