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

NCT00414453 | Terminated Phase 4 Results

• 1 other identifier: TALENT-MS
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Chronic Pain; Multiple Sclerosis

Keywords

Neuropathic pain; Chronic pain; Multiple sclerosis; Central neuropathic pain; Peripheral neuropathic pain; Opioid analgesic; Lidocaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)

  rating of adverse events occur at each visit

• 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

Study Arms (1)

Lidocaine 5% + placebo patch, ER and placebo pills

ACTIVE COMPARATOR

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%; Drug: Extended-release oxycodone; Drug: Placebo extended-release oxycodone pills; Drug: Placebo lidocaine patches

Interventions

Lidocaine patch 5% DRUG

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

Also known as: Lidoderm

Lidocaine 5% + placebo patch, ER and placebo pills

Extended-release oxycodone DRUG

extended-release oxycodone titrating schedule

Also known as: Oxycontin

Lidocaine 5% + placebo patch, ER and placebo pills

Placebo extended-release oxycodone pills DRUG

placebo pills with titrating schedule

Also known as: Placebo pill

Lidocaine 5% + placebo patch, ER and placebo pills

Placebo lidocaine patches DRUG

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

Also known as: Placebo patch

Lidocaine 5% + placebo patch, ER and placebo pills

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• "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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Endo Pharmaceuticals: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neuralgia; Chronic Pain; Multiple Sclerosis

Interventions

Lidoderm; Oxycodone

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Robert H Dworkin
• Organization: University of Rochester

robert_dworkin@urmc.rochester.edu

275-8214

Study Officials

• Robert H. Dworkin, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 21, 2006
• Study Start: January 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 17, 2015
• Results First Posted: July 17, 2015

Record last verified: 2015-06

Locations

US (1)