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

• ClinicalTrials.gov Identifier: NCT00414453
• Recruitment Status: Terminated
• First Posted: December 21, 2006
• Results First Posted: July 17, 2015
• Last Update Posted: July 17, 2015
• Sponsor: University of Rochester
• Collaborator: Endo Pharmaceuticals
• Information provided by (Responsible Party): Robert Dworkin, University of Rochester

Tracking Information

• First Submitted Date: December 19, 2006
• First Posted Date: December 21, 2006
• Results First Submitted Date: March 11, 2015
• Results First Posted Date: July 17, 2015
• Last Update Posted Date: July 17, 2015
• Study Start Date: January 2007
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 23, 2015)

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

• Original Primary Outcome Measures (submitted: December 20, 2006): Mean daily diary pain ratings during final week of each treatment period

Current Secondary Outcome Measures (submitted: June 23, 2015)

• 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
• 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
• Brief Pain Inventory Interference Items [ Time Frame: occurs Visit 1, 3,4,5 ]
  subject completes the brief pain questionaire
• Daily Diary Sleep Interference Ratings [ Time Frame: daily ]
  Subject identifies degree of sleep interference on a daily basis
• Beck Depression Inventory [ Time Frame: occurs at Visit 1, 3, 4 and 5 ]
  Subject completes Beck questionaire
• 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
• Short-Form McGill Pain Questionnaire [ Time Frame: Occurs Visit 1, 3, 4 and 5 ]
  Subject completes short form McGill Pain questionaire
• Patient Global Impression of Change Scale [ Time Frame: Occurs Visit 3, 4, 5 ]
  Subject completes patient global impression questionaire of change scale
• Kurtzke Expanded Disability Status Scale [ Time Frame: Occurs at Visit 1 ]
  Subject completes questionaire on functional status

Original Secondary Outcome Measures (submitted: December 20, 2006)

• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis
• Official Title: Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (TALENT-MS)
• 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.
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Neuropathic Pain
• Chronic Pain
• Multiple Sclerosis

Intervention

• 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

Study Arms

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

Interventions:

• Drug: Lidocaine patch 5%
• Drug: Extended-release oxycodone
• Drug: Placebo extended-release oxycodone pills
• Drug: Placebo lidocaine patches

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: August 16, 2011): 19
• Original Enrollment (submitted: December 20, 2006): 60
• Actual Study Completion Date: August 2011
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00414453
• Other Study ID Numbers: TALENT-MS
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Robert Dworkin, University of Rochester
• Original Responsible Party: Not Provided
• Current Study Sponsor: University of Rochester
• Original Study Sponsor: Same as current
• Collaborators: Endo Pharmaceuticals

Investigators

• Principal Investigator: Robert H. Dworkin, PhD; University of Rochester

• PRS Account: University of Rochester
• Verification Date: June 2015