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

NCT ID: NCT00414453

Last Updated: 2015-07-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2011-08-31

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.

Conditions

Neuropathic Pain; Chronic Pain; Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Lidocaine patch 5%

Intervention Type: DRUG

lidocaine 5% patch; 12 hours on, 12 hours off

Extended-release oxycodone

Intervention Type: DRUG

extended-release oxycodone titrating schedule

Placebo extended-release oxycodone pills

Intervention Type: DRUG

placebo pills with titrating schedule

Placebo lidocaine patches

Intervention Type: DRUG

used with extended release oxycodone group; used with placebo pills/placebo patches

Interventions

Lidocaine patch 5%

lidocaine 5% patch; 12 hours on, 12 hours off

Intervention Type: DRUG

Extended-release oxycodone

extended-release oxycodone titrating schedule

Intervention Type: DRUG

Placebo extended-release oxycodone pills

placebo pills with titrating schedule

Intervention Type: DRUG

Placebo lidocaine patches

used with extended release oxycodone group; used with placebo pills/placebo patches

Intervention Type: DRUG

Other Intervention Names

Lidoderm; Oxycontin; Placebo pill; Placebo patch

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Robert Dworkin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert H. Dworkin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

TALENT-MS

Identifier Type: -

Identifier Source: org_study_id