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

Phase 4

Terminated

Conditions: Chronic Pain
Multiple Sclerosis
Neuropathic Pain

Interventions: Drug: Lidocaine patch 5%
Drug: Extended-release oxycodone
Drug: Placebo extended-release oxycodone pills
Drug: Placebo lidocaine patches

Registration Number: NCT00414453

Lead Sponsor: University of Rochester

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 19

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lidocaine 5% + placebo patch, ER and placebo pills	Lidocaine patch 5%	5% lidocaine patch used as intervention placebo patch used with extended release oxycodone or with placebo pills and placebo patches a randomized subjects given extended release oxycodone and placebo patches during this treatment placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group period
Lidocaine 5% + placebo patch, ER and placebo pills	Extended-release oxycodone	5% lidocaine patch used as intervention placebo patch used with extended release oxycodone or with placebo pills and placebo patches a randomized subjects given extended release oxycodone and placebo patches during this treatment placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group period
Lidocaine 5% + placebo patch, ER and placebo pills	Placebo extended-release oxycodone pills	5% lidocaine patch used as intervention placebo patch used with extended release oxycodone or with placebo pills and placebo patches a randomized subjects given extended release oxycodone and placebo patches during this treatment placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group period
Lidocaine 5% + placebo patch, ER and placebo pills	Placebo lidocaine patches	5% lidocaine patch used as intervention placebo patch used with extended release oxycodone or with placebo pills and placebo patches a randomized subjects given extended release oxycodone and placebo patches during this treatment placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group period

Primary Outcome Measures

Name	Time	Method
Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period	Daily	subject identifies daily pain rating during final week of each treatment period using a numeric rating scale

Secondary Outcome Measures

Name	Time	Method
Safety (i.e., Number of Serious Adverse Events)	rating and review of any adverse events occurs at each visit	Subject is asked about any adverse events that may have occurred since last contact; also subject can document any adverse events on daily pain diary scales
Brief Pain Inventory Interference Items	occurs Visit 1, 3,4,5	subject completes the brief pain questionaire
Daily Diary Sleep Interference Ratings	daily	Subject identifies degree of sleep interference on a daily basis
Beck Depression Inventory	occurs at Visit 1, 3, 4 and 5	Subject completes Beck questionaire
Short-Form McGill Pain Questionnaire	Occurs Visit 1, 3, 4 and 5	Subject completes short form McGill Pain questionaire
Kurtzke Expanded Disability Status Scale	Occurs at Visit 1	Subject completes questionaire on functional status
Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)	rating of adverse events occur at each visit	subject is questioned regarding any adverse events that have occured since the last contact; also subject can document any issues on daily pain rating diaries
Short-form Health Survey 36 (SF-36)	Occurs at Visit 1, 3, 4 and 5	Subject completes short form health survey 36 questionaire
Patient Global Impression of Change Scale	Occurs Visit 3, 4, 5	Subject completes patient global impression questionaire of change scale