Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis

Inclusion Criteria:

• "Definite MS" as defined by revised McDonald criteria.

• Bilateral distal symmetric burning pain involving both feet for at least three months.

• Baseline weekly average pain rating equal to four or greater on 0-10 numerical scale.

• Stable MS medication and pain-related medications for 8 weeks prior to screening.

• Must come to Research Center for appointments

Exclusion Criteria:

• Topical treatment with lidocaine, capsaicin, or other topical analgesics within 3months prior to screening.

• Any treatment with opioid analgesics or tramadol within 3 months prior to screening.

• Hypersensitivity to Lidoderm, lidocaine, or other local anesthetics.

• Hypersensitivity or inability to tolerate opioid analgesics.

• Current treatment with a total of 3 or more antidepressant or anticonvulsant drugs forpain.

• Current treatment with Class I anti-arrhythmic agents at baseline.

• Beck Depression Inventory score > 16 or clinically significant depression or dementia.

• History of suicide attempt or current intent or plan.

• History of excessive alcohol use or any illicit drug use within the past 2 years.

• Lack of adequate birth control in pre-menopausal women of childbearing age.

• Other pain more severe than lower extremity burning pain.

• Open skin lesions in the area where the lidocaine patch is to be applied.

• Cancer within the previous 5 years other than skin cancer.

• MS exacerbation or any treatment with corticosteroids within 3 months prior toscreening.

• History of peripheral neuropathy, lower limb amputation, or another neuromuscularsyndrome or systemic disorder known to be associated with sensory neuropathy.

• Does not meet criteria of baseline lab values at screening visit.

• Nerve conduction studies consistent with peripheral neuropathy.