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Trial of Analgesia With Lidocaine or Extended-Release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis
This study is currently recruiting participants.
Verified by University of Rochester, December 2006
First Received: December 19, 2006   Last Updated: February 12, 2009   History of Changes
Sponsor: University of Rochester
Collaborator: Endo Pharmaceuticals
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00414453
  Purpose

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 Intervention 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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Trial of Analgesia With Lidocaine or Extended-Release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (TALENT-MS)

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Mean daily diary pain ratings during final week of each treatment period

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: January 2007
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414453

Contacts
Contact: Janet A Vaughan, MS, NP 585-273-2445 janet_vaughan@urmc.rochester.edu
Contact: Lisa M Bailey, RN 585-275-3910 lisa_bailey@urmc.rochester.edu

Locations
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Endo Pharmaceuticals
Investigators
Principal Investigator: Robert H. Dworkin, PhD University of Rochester School of Medicine and Dentistry
  More Information

No publications provided

Study ID Numbers: TALENT-MS
Study First Received: December 19, 2006
Last Updated: February 12, 2009
ClinicalTrials.gov Identifier: NCT00414453     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Neuropathic pain
Chronic pain
Multiple sclerosis
Central neuropathic pain
Peripheral neuropathic pain
Opioid analgesic
Lidocaine

Additional relevant MeSH terms:
Oxycodone
Physiological Effects of Drugs
Anesthetics
Pain
Signs and Symptoms
Pathologic Processes
Multiple Sclerosis
Neuromuscular Diseases
Sensory System Agents
Therapeutic Uses
Analgesics
Anti-Arrhythmia Agents
Analgesics, Opioid
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Demyelinating Diseases
Neuralgia
Nervous System Diseases
Lidocaine
Central Nervous System Depressants
Narcotics
Sclerosis
Cardiovascular Agents
Anesthetics, Local
Pharmacologic Actions
Peripheral Nervous System Diseases
Neurologic Manifestations
Demyelinating Autoimmune Diseases, CNS
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010