A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy
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Purpose
The purpose of this trial is to assess whether 400mg/day of lacosamide is effective in reducing pain caused by distal diabetic neuropathy. Two dose-escalation schemes for lacosamide will be used to further determine the efficacy of the "standard" scheme and to evaluate the efficacy and safety of a more rapid titration scheme. Subjects will be randomly assigned to one of three treatment groups. Subjects in two of the groups will receive lacosamide at a dose of 400mg/day, but different dose-escalation schemes will be used to reach this final dose. The third group of subjects will receive a placebo. Subjects will have a 2 in 3 (66 %) chance of getting lacosamide.
The maximum lacosamide dose in this trial will be 400mg/day. The maximum treatment duration will be 18 weeks, including a two-week Pre-Treatment Phase and a 12 weeks period on a stable dose of lacosamide or placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Painful Diabetic Neuropathy |
Drug: SPM 929 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-blind, Placebo Controlled Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy Using Two Different Titration Schemes |
- To investigate the efficacy of LCM compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy. Two titration schemes will be used; the first is a standard titration scheme such that the target dose of 400mg/day [ Time Frame: 8 days and 22 days ]
- To investigate the onset of action under treatment of LCM, the effect of LCM on subjects' perception of pain, sleep, activity, and quality of life, and to further investigate the safety of LCM
| Estimated Enrollment: | 537 |
| Study Start Date: | June 2006 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject has had symptoms of painful diabetic neuropathy for at least 6 months and has a diagnosis of diabetes mellitus (Type I or Type II).
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00350103 History of Changes |
| Other Study ID Numbers: | SP874 |
| Study First Received: | July 6, 2006 |
| Last Updated: | September 9, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetic Neuropathies Pain Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Peripheral Nervous System Diseases |
Neuromuscular Diseases Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Signs and Symptoms Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on June 17, 2013