Trial of Analgesia With Lidocaine or Extended-Release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis
Information source: University of Rochester
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuropathic Pain; Chronic Pain; Multiple Sclerosis
Intervention: Lidocaine patch 5% (Drug); Extended-release oxycodone (Drug); Placebo extended-release oxycodone pills (Drug); Placebo lidocaine patches (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Rochester Official(s) and/or principal investigator(s):
Robert H. Dworkin, PhD, Principal Investigator, Affiliation: University of Rochester School of Medicine and Dentistry
Overall contact:
Janet A Vaughan, MS, NP, Phone: 585-273-2445, Email: janet_vaughan@urmc.rochester.edu
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.
Clinical Details
Official title: Trial of Analgesia With Lidocaine or Extended-Release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (TALENT-MS)
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Mean daily diary pain ratings during final week of each treatment period
Secondary outcome: Tolerability (e.g., number of adverse effects, number of drop-outs)Safety (i.e., number of serious adverse events) Brief Pain Inventory interference items Daily diary sleep interference ratings Beck Depression Inventory Short-form Health Survey 36 (SF-36) Short-Form McGill Pain Questionnaire Patient Global Impression of Change scale Kurtzke Expanded Disability Status Scale
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Janet A Vaughan, MS, NP, Phone: 585-273-2445, Email: janet_vaughan@urmc.rochester.edu
University of Rochester Medical Center, Rochester, New York 14642, United States; Recruiting
Additional Information
Starting date: January 2007
Last updated: July 8, 2008
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