Multiple Sclerosis Clinical Trial

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

Summary

This study will determine whether treatment with an extended-release opioid or topical lidocaine is effective in relieving distal symmetric lower extremity burning pain associated with multiple sclerosis (MS). If treatment with topical lidocaine is efficacious, it will have important implications for understanding this chronic pain syndrome, which is widely assumed to be caused by central nervous system pathology.

View Full Description

Full Description

This study is a single-center, double-blind, 15-week, 3-period crossover clinical trial. Subjects will complete each of the following 5-week long periods (unless they withdraw from the trial): 1) placebo pills and topical lidocaine patches, 2)extended-release oxycodone pills and placebo(vehicle) patches, and 3)placebo pills and placebo patches. Sixty subjects will be randomized to one of 6 treatment sequences. It is expected that this trial will take approximately 2 years to complete.

View Eligibility Criteria

Eligibility Criteria

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 3 months 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 for pain.
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 to screening.
History of peripheral neuropathy, lower limb amputation, or another neuromuscular syndrome 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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

19

Study ID:

NCT00414453

Recruitment Status:

Terminated

Sponsor:

University of Rochester

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

University of Rochester Medical Center
Rochester New York, 14642, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

19

Study ID:

NCT00414453

Recruitment Status:

Terminated

Sponsor:


University of Rochester

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider