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

NCT ID: NCT00220337

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 371 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-21
• Study Completion Date: 2007-10-31

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.

Conditions

Painful Diabetic Neuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lacosamide (LCM)

Open label active treatment

Group Type: EXPERIMENTAL

Lacosamide

Intervention Type: DRUG

Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years

Interventions

Lacosamide

Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years

Intervention Type: DRUG

Other Intervention Names

SPM 927

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SCHWARZ BIOSCIENCES GmbH - Part of UCB Group

UNKNOWN

Sponsor Role: collaborator

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

UCB (+1 844 599 2273)

Locations

Monheim, , Germany

Countries

Germany

Other Identifiers

2004-000960-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP0830

Identifier Type: -

Identifier Source: org_study_id