Status:
COMPLETED
An Efficacy and Safety Study of Carisbamate in the Treatment of Nerve Pain in Diabetics
Lead Sponsor:
SK Life Science, Inc.
Conditions:
Diabetic Neuropathies
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of carisbamate (800 and 1200 mg/day) in patients with diabetic neuropathic pain.
Detailed Description
This is a randomized (study medication assigned by chance), double-blind (neither the investigator or the patient knows the name of the study assigned drug), placebo- and active-controlled, parallel-g...
Eligibility Criteria
Inclusion
- Patients with diabetes mellitus (type 1 or 2)
- Have had diabetes-related painful peripheral neuropathy in the lower extremities for \>=6 months prior to entry
- Have experienced lower extremity pain on a nearly daily basis for the previous 3 months
- Have a mean daily average DPN pain score of \>=4 (on an 11-point scale) during the baseline period
- Have had a stable diabetic treatment regimen, including oral hypoglycemics, insulin, or diet, for \>=3 months before screening
- Have hemoglobin A1c levels \<=11%
- Willing to discontinue prohibited medications, including antiepileptic drugs (including gabapentin and pregabalin), opioids or opioid-containing pain medications, and antidepressants
- Women must be postmenopausal for \>=2 years, surgically sterile, abstinent, or practicing a highly effective method of birth control
- Women of childbearing potential must have a negative pregnancy test at screening and on Day 1.
Exclusion
- History of poor response to \>=3 classes of medications for DPN
- Currently taking warfarin (Coumadin)
- Prior treatment with neurolysis (destruction of nerves by application of chemicals, heat, or cold), neurosurgery, intrathecal pumps, or spinal cord stimulators for DPN
- Use of herbal topical creams or ointments for pain relief with 48 hours, capsaicin with 6 months, or systemic (oral) corticosteroids with 3 months before the baseline period
- Any dermatologic or vascular disease in the limbs affected by the neuralgia that may interfere with assessment, including a diabetic ulcer or to or limb amputation
- Hospitalized within the last month for episodes of hypoglycemia or hyperglycemia
- History of progressive or neurologic disorders (such as multiple sclerosis, amyotrophic lateral sclerosis)
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT00870454
Start Date
May 1 2009
End Date
December 1 2010
Last Update
January 24 2013
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