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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00414453
Recruitment Status : Terminated (Did not reach enrollment goals)
First Posted : December 21, 2006
Results First Posted : July 17, 2015
Last Update Posted : July 17, 2015
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Robert Dworkin, University of Rochester

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Chronic Pain Multiple Sclerosis Drug: Lidocaine patch 5% Drug: Extended-release oxycodone Drug: Placebo extended-release oxycodone pills Drug: Placebo lidocaine patches Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (TALENT-MS)
Study Start Date : January 2007
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Lidoderm

Drug: Extended-release oxycodone
extended-release oxycodone titrating schedule
Other Name: Oxycontin

Drug: Placebo extended-release oxycodone pills
placebo pills with titrating schedule
Other Name: Placebo pill

Drug: Placebo lidocaine patches
used with extended release oxycodone group; used with placebo pills/placebo patches
Other Name: Placebo patch


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs) [ Time Frame: rating of adverse events occur at each visit ]
    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

  2. Safety (i.e., Number of Serious Adverse Events) [ Time Frame: rating and review of any adverse events occurs at each visit ]
    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

  3. Brief Pain Inventory Interference Items [ Time Frame: occurs Visit 1, 3,4,5 ]
    subject completes the brief pain questionaire

  4. Daily Diary Sleep Interference Ratings [ Time Frame: daily ]
    Subject identifies degree of sleep interference on a daily basis

  5. Beck Depression Inventory [ Time Frame: occurs at Visit 1, 3, 4 and 5 ]
    Subject completes Beck questionaire

  6. Short-form Health Survey 36 (SF-36) [ Time Frame: Occurs at Visit 1, 3, 4 and 5 ]
    Subject completes short form health survey 36 questionaire

  7. Short-Form McGill Pain Questionnaire [ Time Frame: Occurs Visit 1, 3, 4 and 5 ]
    Subject completes short form McGill Pain questionaire

  8. Patient Global Impression of Change Scale [ Time Frame: Occurs Visit 3, 4, 5 ]
    Subject completes patient global impression questionaire of change scale

  9. Kurtzke Expanded Disability Status Scale [ Time Frame: Occurs at Visit 1 ]
    Subject completes questionaire on functional status


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414453


Locations
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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Endo Pharmaceuticals
Investigators
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Principal Investigator: Robert H. Dworkin, PhD University of Rochester
More Information
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Responsible Party: Robert Dworkin, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT00414453    
Other Study ID Numbers: TALENT-MS
First Posted: December 21, 2006    Key Record Dates
Results First Posted: July 17, 2015
Last Update Posted: July 17, 2015
Last Verified: June 2015
Keywords provided by Robert Dworkin, University of Rochester:
Neuropathic pain
Chronic pain
Multiple sclerosis
Central neuropathic pain
 Peripheral neuropathic pain
Opioid analgesic
Lidocaine
Additional relevant MeSH terms:
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Multiple Sclerosis
Neuralgia
Sclerosis
Chronic Pain
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Lidocaine
Oxycodone
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics