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

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

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis; Chronic Pain; Neuropathic Pain
• Intervention / Treatment: Drug: Lidocaine patch 5%; Drug: Extended-release oxycodone; Drug: Placebo extended-release oxycodone pills; Drug: Placebo lidocaine patches

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: 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

Drug: Lidocaine patch 5%; lidocaine 5% patch; 12 hours on, 12 hours off; Other Names: Lidoderm; Drug: Extended-release oxycodone; extended-release oxycodone titrating schedule; Other Names: Oxycontin; Drug: Placebo extended-release oxycodone pills; placebo pills with titrating schedule; Other Names: Placebo pill; Drug: Placebo lidocaine patches; used with extended release oxycodone group; used with placebo pills/placebo patches; Other Names: Placebo patch

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)	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	rating of adverse events occur at each visit
Safety (i.e., Number of Serious Adverse Events)	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	rating and review of any adverse events occurs at each visit
Brief Pain Inventory Interference Items	subject completes the brief pain questionaire	occurs Visit 1, 3,4,5
Daily Diary Sleep Interference Ratings	Subject identifies degree of sleep interference on a daily basis	daily
Beck Depression Inventory	Subject completes Beck questionaire	occurs at Visit 1, 3, 4 and 5
Short-form Health Survey 36 (SF-36)	Subject completes short form health survey 36 questionaire	Occurs at Visit 1, 3, 4 and 5
Short-Form McGill Pain Questionnaire	Subject completes short form McGill Pain questionaire	Occurs Visit 1, 3, 4 and 5
Patient Global Impression of Change Scale	Subject completes patient global impression questionaire of change scale	Occurs Visit 3, 4, 5
Kurtzke Expanded Disability Status Scale	Subject completes questionaire on functional status	Occurs at Visit 1

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Endo Pharmaceuticals
• Investigators: Principal Investigator: Robert H. Dworkin, PhD, University of Rochester

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: December 19, 2006
• First Submitted That Met QC Criteria: December 20, 2006
• First Posted (Estimate): December 21, 2006

Study Record Updates

• Last Update Posted (Estimate): July 17, 2015
• Last Update Submitted That Met QC Criteria: June 23, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Chronic pain; Multiple sclerosis; Neuropathic pain; Lidocaine; Central neuropathic pain; Peripheral neuropathic pain; Opioid analgesic
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Multiple Sclerosis; Sclerosis; Chronic Pain; Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Oxycodone
• Other Study ID Numbers: TALENT-MS