Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00135109
• Date of registration: 23/08/2005
• Primary sponsor: UCB, Inc.
• Public title: Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy
• Scientific title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy
• Date of first enrolment: October 2004
• Target sample size: 654
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00135109
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: UCB, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diabetic neuropathy

Exclusion Criteria:

- Subject has previously participated in this trial or subject has previously been
assigned to treatment in a trial of the drug under investigation in this trial.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic Neuropathies

Intervention(s)

Drug: SPM 927

Primary Outcome(s)

To investigate the efficacy of 200, 400, and 600mg/day of lacosamide compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy.

Secondary Outcome(s)

To investigate the effect of lacosamide on subjects' perception of pain, sleep, activity, and quality of life, as well as to investigate the pharmacokinetics and safety of lacosamide.

Secondary ID(s)

SP768

Source(s) of Monetary Support

Please refer to primary and secondary sponsors