Clinical trial NCT00414453: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Neuropathic Pain
Chronic Pain
Multiple Sclerosis
Keywords: Neuropathic pain
Chronic pain
Multiple sclerosis
Central neuropathic pain
Peripheral neuropathic pain
Opioid analgesic
Lidocaine
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Endo Pharmaceuticals
First posted: 2006-12-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period
timeFrame: Daily
Secondary outcomes:
measure: Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)
timeFrame: rating of adverse events occur at each visit
measure: Safety (i.e., Number of Serious Adverse Events)
timeFrame: rating and review of any adverse events occurs at each visit
measure: Brief Pain Inventory Interference Items
timeFrame: occurs Visit 1, 3,4,5
measure: Daily Diary Sleep Interference Ratings
timeFrame: daily
measure: Beck Depression Inventory
timeFrame: occurs at Visit 1, 3, 4 and 5
measure: Short-form Health Survey 36 (SF-36)
timeFrame: Occurs at Visit 1, 3, 4 and 5
measure: Short-Form McGill Pain Questionnaire
timeFrame: Occurs Visit 1, 3, 4 and 5
measure: Patient Global Impression of Change Scale
timeFrame: Occurs Visit 3, 4, 5
measure: Kurtzke Expanded Disability Status Scale
timeFrame: Occurs at Visit 1
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Robert H. Dworkin, PhD
role: PRINCIPAL_INVESTIGATOR
References: