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A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00220337
First received: September 1, 2005
Last updated: September 9, 2009
Last verified: September 2009
History of Changes

September 1, 2005
September 9, 2009
December 2004
October 2007   (final data collection date for primary outcome measure)
To assess the tolerability and safety of long-term lacosamide administration in subjects with painful diabetic neuropathy. Assessment of adverse events, changes in laboratory parameters, ECGs, and physical examinations.
Not Provided
Complete list of historical versions of study NCT00220337 on ClinicalTrials.gov Archive Site
To evaluate the efficacy of long-term use of lacosamide in this indication. Efficacy will be determined by pain score ratings assessed in a patient's diary and with ratings at the clinic visits.
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A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
A Multicenter, Open-label Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy

The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a longer period of time and whether it continues to work well to treat pain.

Subjects will receive lacosamide at a dose that will be individually determined to be the one that provides most pain relief with the least side effects. The maximum dose will be 600mg/day. Subjects may participate in this trial until October 2007. This time may be extended to allow them to participate until lacosamide is commercially available.

If a subject meet the requirements for the study at Visit 1 and after a two weeks phase without trial medication, s/he enters a Titration Phase to determine the personal optimal dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks thereafter.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Painful Diabetic Neuropathy
Drug: lacosamide
Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years
Other Name: SPM 927
Experimental: 1
Open label active treatment
Intervention: Drug: lacosamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
371
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Painful diabetic neuropathy

Exclusion Criteria:

  • no clinically relevant liver enzyme abnormalities and impaired renal function, no cardiac abnormalities, no pregnant or nursing females
Both
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Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00220337
SP830
Not Provided
Study Director, UCB
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP