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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00220337
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2014
Information provided by:
UCB Pharma

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 371 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Lacosamide

Arm Intervention/treatment
Experimental: 1
Open label active treatment
Drug: lacosamide
Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years
Other Name: SPM 927

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00220337

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Monheim, Germany
Sponsors and Collaborators
UCB Pharma
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
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Responsible Party: Study Director, UCB Identifier: NCT00220337    
Other Study ID Numbers: SP0830
2004-000960-28 ( EudraCT Number )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: September 2009
Additional relevant MeSH terms:
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Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action