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

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Oxycodone Oxycodone hydrochloride Lidocaine

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Mean daily diary pain ratings during final week of each treatment period [ Time Frame: Daily ] [ Designated as safety issue: No ]
subject identifies daily pain rating using a numeric rating scale

Secondary Outcome Measures:

Tolerability (e.g., number of adverse effects, number of drop-outs) [ Time Frame: rating of adverse events occur at each visit ] [ Designated as safety issue: Yes ]
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
Safety (i.e., number of serious adverse events) [ Time Frame: rating and review of any adverse events occurs at each visit ] [ Designated as safety issue: Yes ]
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
Brief Pain Inventory interference items [ Time Frame: occurs Visit 1, 3,4,5 ] [ Designated as safety issue: No ]
subject completes the brief pain questionaire
Daily diary sleep interference ratings [ Time Frame: daily ] [ Designated as safety issue: No ]
Subject identifies degree of sleep interference on a daily basis
Beck Depression Inventory [ Time Frame: occurs at Visit 1, 3, 4 and 5 ] [ Designated as safety issue: Yes ]
Subject completes Beck questionaire
Short-form Health Survey 36 (SF-36) [ Time Frame: Occurs at Visit 1, 3, 4 and 5 ] [ Designated as safety issue: No ]
Subject completes questionaire
Short-Form McGill Pain Questionnaire [ Time Frame: Occurs Visit 1, 3, 4 and 5 ] [ Designated as safety issue: No ]
Subject completes questionaire
Patient Global Impression of Change scale [ Time Frame: Occurs Visit 3, 4, 5 ] [ Designated as safety issue: No ]
Subject completes questionaire
Kurtzke Expanded Disability Status Scale [ Time Frame: Occurs at Visit 1 ] [ Designated as safety issue: No ]
Subject completes questionaire on functional status

Enrollment:	19
Study Start Date:	January 2007
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Lidocaine Patch 5% 5% lidocaine patch used as intervention	Drug: Lidocaine patch 5% lidocaine 5% patch; 12 hours on, 12 hours off Other Name: Lidoderm
Placebo Comparator: placebo patch placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm	Drug: Placebo lidocaine patches used with extended release oxycodone group; used with placebo pills/placebo patches
Active Comparator: extended release oxycodone randomized subjects given extended release oxycodone and placebo patches during this treatment period	Drug: Extended-release oxycodone extended-release oxycodone titrating schedule Other Name: Oxycontin
Placebo Comparator: placebo pills placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group	Drug: Placebo extended-release oxycodone pills placebo pills with titrating schedule

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

Locations

United States, New York
University of Rochester Medical Center
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

Responsible Party:	Robert H. Dworkin, PhD, University of Rochester
ClinicalTrials.gov Identifier:	NCT00414453 History of Changes
Other Study ID Numbers:	TALENT-MS
Study First Received:	December 19, 2006
Last Updated:	August 16, 2011
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:

Multiple Sclerosis
Neuralgia
Sclerosis
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
Signs and Symptoms
Pathologic Processes

Lidocaine
Oxycodone
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Narcotics
Analgesics

ClinicalTrials.gov processed this record on February 09, 2012