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

UCB

Status and phase: Completed; Phase 3

Conditions: Painful Diabetic Neuropathy

Treatments: Drug: Lacosamide

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00220337

2004-000960-28 (EudraCT Number)

SP0830

Details and patient eligibility

About

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.

Enrollment: 371 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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371 participants in 1 patient group

Lacosamide (LCM)

Experimental group

Description:

Open label active treatment

Treatment:

Drug: Lacosamide