A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
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|ClinicalTrials.gov Identifier: NCT00220337|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Painful Diabetic Neuropathy||Drug: lacosamide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||371 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
Open label active treatment
Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years
Other Name: SPM 927
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220337
|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|