Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (TALENT-MS)
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- University of Rochester
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Lidocaine 5% + placebo patch, ER and placebo 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
Intervention: Lidocaine patch 5% (Drug)
Lidocaine 5% + placebo patch, ER and placebo 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
Intervention: Extended-release oxycodone (Drug)
Lidocaine 5% + placebo patch, ER and placebo 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
Intervention: Placebo extended-release oxycodone pills (Drug)
Lidocaine 5% + placebo patch, ER and placebo 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
Intervention: Placebo lidocaine patches (Drug)
Outcomes
Primary Outcomes
Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period
Time Frame: Daily
subject identifies daily pain rating during final week of each treatment period using a numeric rating scale
Secondary Outcomes
- Safety (i.e., Number of Serious Adverse Events)(rating and review of any adverse events occurs at each visit)
- Brief Pain Inventory Interference Items(occurs Visit 1, 3,4,5)
- Daily Diary Sleep Interference Ratings(daily)
- Beck Depression Inventory(occurs at Visit 1, 3, 4 and 5)
- Short-Form McGill Pain Questionnaire(Occurs Visit 1, 3, 4 and 5)
- Kurtzke Expanded Disability Status Scale(Occurs at Visit 1)
- Short-form Health Survey 36 (SF-36)(Occurs at Visit 1, 3, 4 and 5)
- Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)(rating of adverse events occur at each visit)
- Patient Global Impression of Change Scale(Occurs Visit 3, 4, 5)
Investigators
Robert Dworkin
Principal Investigator
University of Rochester