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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00414453
• Other study ID #: TALENT-MS
• Status: Terminated
• Phase: Phase 4
• First received: December 19, 2006
• Last updated: June 23, 2015
• Start date: January 2007
• Est. completion date: August 2011

Study information

• Verified date: June 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Chronic Pain
• Multiple Sclerosis
• Neuralgia
• Neuropathic Pain
• Sclerosis

Intervention

Drug:
• Lidocaine patch 5%
lidocaine 5% patch; 12 hours on, 12 hours off
• Extended-release oxycodone
extended-release oxycodone titrating schedule
• Placebo extended-release oxycodone pills
placebo pills with titrating schedule
• Placebo lidocaine patches
used with extended release oxycodone group; used with placebo pills/placebo patches

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period	subject identifies daily pain rating during final week of each treatment period using a numeric rating scale	Daily	No
Secondary	Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)	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	rating of adverse events occur at each visit	Yes
Secondary	Safety (i.e., Number of Serious Adverse Events)	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	rating and review of any adverse events occurs at each visit	Yes
Secondary	Brief Pain Inventory Interference Items	subject completes the brief pain questionaire	occurs Visit 1, 3,4,5	No
Secondary	Daily Diary Sleep Interference Ratings	Subject identifies degree of sleep interference on a daily basis	daily	No
Secondary	Beck Depression Inventory	Subject completes Beck questionaire	occurs at Visit 1, 3, 4 and 5	Yes
Secondary	Short-form Health Survey 36 (SF-36)	Subject completes short form health survey 36 questionaire	Occurs at Visit 1, 3, 4 and 5	No
Secondary	Short-Form McGill Pain Questionnaire	Subject completes short form McGill Pain questionaire	Occurs Visit 1, 3, 4 and 5	No
Secondary	Patient Global Impression of Change Scale	Subject completes patient global impression questionaire of change scale	Occurs Visit 3, 4, 5	No
Secondary	Kurtzke Expanded Disability Status Scale	Subject completes questionaire on functional status	Occurs at Visit 1	No