Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis
This study has been terminated.
(Did not reach enrollment goals)
Sponsor:
University of Rochester
Collaborator:
Endo Pharmaceuticals
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00414453
First received: December 19, 2006
Last updated: August 16, 2011
Last verified: August 2011
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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 4 |
| 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:
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 May 19, 2013